Deafness, Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
Conditions
Keywords
Bone anchored hearing aid, Bone anchored implant, Abbreviated Profile of Hearing Aid Benefit (APHAB), Health Utility Index (HUI), Holgers Index, Implant stability
Brief summary
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment). To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).
Detailed description
Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact. The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012. The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.
Interventions
DEVICEMinimally invasive surgery and BA400
The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).
DEVICETraditional surgery and BA300
The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
Sponsors
Cochlear Bone Anchored Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for the Baha system * Signed informed consent
Exclusion criteria
* Patient scheduled for simultaneously bilateral implant surgery * Uncontrolled diabetes as judged by the investigator * Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids * Unable to follow the cleaning instruction * Unable to follow investigational procedures, e.g. to complete quality of life scales * Participation in another investigation with pharmaceuticals and/or device * Condition that may have an impact on the outcome of the investigation as judged by the investigator * Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | 12 months | Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation - Max of Holgers Index | From Day 10 to 12 Months, and to 36 Months | Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection. 0\. No irritation 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* R. Removal of the abutment / implant necessary due to infection\* R Removal of implant for reasons not related to skin problems\* |
| Max Numbness | 12 & 36 months | Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used: 1. No numbness 2. Numbness within 2 cm from the abutment 3. Numbness within and beyond 2 cm from the abutment |
| Pain in the Scar and Neuropathic Pain | Day 10, Weeks 3, 6, 12, 24, Months 12 and 36 | The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. |
| Pain - Maximum of Neuropathic and Scar Pain | 12 months | The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months. |
| Pain by Visit - Categorical | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'. |
| Soft Tissue Thickening/Overgrowth | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale: 0\. No soft tissue thickening or overgrowth 1. Slight soft tissue thickening or overgrowth 2. Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated\* 3. Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.\* * Should also be reported on the AE page in the CRF |
| Visible Abutment Length by Visit for Patients With no Change of Abutment | Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36 | The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant. In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment |
| The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12, Months 12 and 36 | The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10. The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color). Both patient and observer should also score the overall opinion of the scar on the 1-10 scale. For all above scales 1=normal skin, 10 worst scar imaginable. Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable). The pain not with in the scar variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain |
| Surgery Time | Day 0 | Surgery time (minutes) was recorded |
| Wound Healing | Day 10, Weeks 3, 6, 12 and 24 | A surgeon or a surgical nurse determined if the wound was healed or not healed. |
| Inflammation - Holgers Index by Visit | Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36 | Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used: 0\. No irritation. Epidermal debris removed, if present 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* 4. Removal of the abutment / implant necessary due to infection\* R. Removal of implant for reasons not related to skin problems\* |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Sound Processor | Weeks 6, 12, 24, Months 12, 24, 36 | Use of the sound processor can be seen as a reflection of patient satisfaction and treatment compliance. Patients were asked to record how many hours per week they used the sound processor after Baha loading at week 3. |
| Implant Stability (ISQ) | Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36 | ISQ is a well-established method to measure stability of osseointegrated implants and has been used for several years both for bone conduction implants and for dental implants. Measurements were performed using resonance frequency analysis at the abutment level. The highest and lowest ISQ value out of two perpendicular measurements obtained at each time point was recorded, ISQ High and ISQ Low. The ISQ values ranges from 1 to 100. Overall, the length of test abutments (BA400) were longer than control abutments (BA300) and there is an inverse correlation between abutment length and stability. A direct comparison between the groups is not relevant. Implant Stability Quotient (ISQ) was recorded at surgery as a baseline value and at visit 2-10. |
| Smoking Habits by Visit | baseline, Weeks 3, 12, Months 12, 24 and 36 | Nicotine use and smoking habits were recorded for patients. 1. Does not smoke 2. Less than 10 cigarettes/day (Low consumption) 3. Between 11 and 20 cigarettes/day (Medium consumption) 4. Between 21 and 40 cigarettes/day (High consumption) 5. More than 40 cigarettes/day (Very high consumption) In Sweden a large proportion of adults use another form of tobacco, wet snuff. In Sweden the patients were asked if they used wet snuff. |
| Loss of Implant | from surgery through to 36 months | 'Loss of Implant' refers to the loss of the implant for reasons including failure of implant to osseointegrate, or an implant that was loose form surgery. It does not include elected removal of the device. |
| Removal of Abutment | from surgery through to 36 months | Count of subjects who had their abutment removed for reasons of health and safety, such as infection, inflammation or pain. |
| Health Utilies Index (HUI-III & HUI-II) | baseline (pre-surgery), week 24, months 12 and 36 | Health Utilities Index (HUI) is a generic preference-based system for measuring comprehensive health status and health-related quality of life. Each index provides descriptive evidence on multiple dimensions of life quality. HUI3: Comprehensive Health State, Vision, Hearing, Speech, Ambulation, Emotion, Cognition, Pain. HUI2: Comprehensive Health State, Sensation, Mobility, Emotion, Cognition, Self Care, Pain. Subjects completed HUI2/3 questionnaires at visit 1 (baseline), 7 (week 24), 8 (month 12) and 10 (month 36). HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead. |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Pre-surgery (baseline) to 24 weeks, 12 and 36 months | The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. The subjects will complete the APHAB at pre-surgery, week 24, month 12 and 36. Questions assess 'Ease of Communication', 'Background Noise', 'Reverberation', 'Aversiveness', and 'Global' in the aided and unaided situations. The aided situation was compared to the unaided situation at baseline (pre-surgery). For each subscale, a score of 99 indicates that there is 'always' difficulty, and a score of 1 indicated that there is 'never' difficulty for that particular subscale. |
Countries
France, Netherlands, Spain, Sweden
Participant flow
Pre-assignment details
106 subjects signed informed consent. Before surgery one subject cancelled surgery, one subject withdraw consent and one subject got the wrong allocation due to logistic problems. This resulted in that 103 subjects received the allocated intervention (51 test and 52 control).
Participants by arm
| Arm | Count |
|---|---|
| Minimally Invasive Surgery and BA400 This arm involves no soft tissue reduction around the BA400 implant.
Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm) | 51 |
| Traditional Surgery and BA300 This arm involves traditional soft tissue reduction around the BA300 implant
Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm). | 52 |
| Total | 103 |
Baseline characteristics
| Characteristic | Traditional Surgery and BA300 | Total | Minimally Invasive Surgery and BA400 |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 16.6 | 52.4 years STANDARD_DEVIATION 14.5 | 54.2 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment France | 5 participants | 10 participants | 5 participants |
| Region of Enrollment Netherlands | 29 participants | 55 participants | 26 participants |
| Region of Enrollment Spain | 14 participants | 29 participants | 15 participants |
| Region of Enrollment Sweden | 4 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 27 Participants | 52 Participants | 25 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
| Type of hearing loss Conductive | 10 participants | 15 participants | 5 participants |
| Type of hearing loss Mixed | 35 participants | 66 participants | 31 participants |
| Type of hearing loss Single-Sided Sensorineural | 7 participants | 22 participants | 15 participants |
| Use of nicotine No | 38 participants | 75 participants | 37 participants |
| Use of nicotine Unknown | 1 participants | 1 participants | 0 participants |
| Use of nicotine Yes | 13 participants | 27 participants | 14 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 52 | 1 / 52 |
| other Total, other adverse events | 35 / 52 | 39 / 52 |
| serious Total, serious adverse events | 7 / 52 | 10 / 52 |
Outcome results
Primary
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Time frame: 12 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 1 | 14 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 3 | 7 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 2 | 14 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 4 | 1 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 0 | 15 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 4 | 0 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 0 | 7 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 1 | 13 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 2 | 24 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 3 | 8 participants |
p-value: 0.12Mantel Haenszel
Primary
Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability
Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events: 1. Holgers Index \>=2 any time between 3 weeks to 1 year 2. Any overgrowth any time between 3 weeks to 1 year 3. Pain (scar/neuropathic) according to POSAS \>=3 any time between 3 weeks to 1 year 4. Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject.
Time frame: 36 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 1 | 12 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 3 | 9 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 2 | 16 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 4 | 2 participants |
| Minimally Invasive Surgery and BA400 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 0 | 12 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 4 | 1 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 0 | 5 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 1 | 15 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 2 | 23 participants |
| Traditional Surgery and BA300 | Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability | Combined endpoint score = 3 | 8 participants |
Comparison: Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only oncep-value: 0.45Mantel Haenszel
Secondary
Inflammation - Holgers Index by Visit
Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used: 0\. No irritation. Epidermal debris removed, if present 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* 4. Removal of the abutment / implant necessary due to infection\* R. Removal of implant for reasons not related to skin problems\*
Time frame: Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to month 36.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 2 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 3 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 0 | 32 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 1 | 15 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 4/ Removal | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 0 | 27 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 1 | 17 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 2 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 3 | 4 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 4/ Removal | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 0 | 32 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 1 | 17 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 2 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 3 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 4/ Removal | 1 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 0 | 33 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 1 | 11 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 2 | 3 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 3 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 4/ Removal | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 0 | 32 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 1 | 13 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 2 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 3 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 4/ Removal | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 0 | 41 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 1 | 4 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 2 | 1 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 3 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 4/ Removal | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 0 | 37 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 1 | 8 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 2 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 3 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 4/ Removal | 1 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 0 | 38 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 1 | 5 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 2 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 3 | 2 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 2 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 2 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 0 | 27 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 1 | 15 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 0 | 40 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 0 | 35 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 1 | 17 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 3 | 1 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 3 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 0 | 37 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Day 10 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 2 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 0 | 33 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 1 | 6 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 1 | 16 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 3 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 2 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 24 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 3 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 2 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 0 | 29 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 0 | 39 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 1 | 18 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 1 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 2 | 3 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 1 | 9 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 3 | 1 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 3 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 6 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 2 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 0 | 36 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 36 | Holgers 3 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 1 | 12 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 3 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 2 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 24 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 3 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Month 12 | Holgers 4/ Removal | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Holgers Index by Visit | Week 12 | Holgers 4/ Removal | 0 Participants |
Comparison: Holgers Index Day 10p-value: 0.38Mantel Haenszel
Comparison: Holgers Index Week 3p-value: 0.17Mantel Haenszel
Comparison: Holgers Index Week 6p-value: 0.37Mantel Haenszel
Comparison: Holgers Index Week 12p-value: 0.73Mantel Haenszel
Comparison: Holgers Index Week 24p-value: 0.47Mantel Haenszel
Comparison: Holgers Index Month 12p-value: 0.73Mantel Haenszel
Comparison: Holgers Index Month 24p-value: 0.37Mantel Haenszel
Comparison: Holgers Index Month 36p-value: 0.75Mantel Haenszel
Secondary
Inflammation - Max of Holgers Index
Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection. 0\. No irritation 1. Slight redness. Local temporary treatment, if needed 2. Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated\* 3. Reddish and moist; sometimes granulations tissue, revision surgery is indicated\* R. Removal of the abutment / implant necessary due to infection\* R Removal of implant for reasons not related to skin problems\*
Time frame: From Day 10 to 12 Months, and to 36 Months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 0 | 10 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 1 | 26 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 2 | 7 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 3 | 8 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 4 | 0 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 0 | 9 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 1 | 23 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 2 | 7 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 3 | 11 Participants |
| Minimally Invasive Surgery and BA400 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 4 | 1 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 2 | 9 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 0 | 8 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 0 | 8 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 1 | 32 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 4 | 0 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 2 | 10 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 1 | 31 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 3 | 2 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 36 Months | Max of Holgers index = 3 | 4 Participants |
| Traditional Surgery and BA300 | Inflammation - Max of Holgers Index | Max of Holgers 12 Months | Max of Holgers index = 4 | 0 Participants |
Comparison: Maximum of Holgers at 12 Monthsp-value: 0.4Mantel Haenszel
Comparison: Maximum of Holgers at 36 Monthsp-value: 0.14Mantel Haenszel
Secondary
Max Numbness
Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used: 1. No numbness 2. Numbness within 2 cm from the abutment 3. Numbness within and beyond 2 cm from the abutment
Time frame: 12 & 36 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 12 months | No numbness | 27 Participants |
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 12 months | Numbness within 2 cm from the abutment | 17 Participants |
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 12 months | Numbness within and beyond 2 cm from the abutment | 7 Participants |
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 36 months | No numbness | 27 Participants |
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 36 months | Numbness within 2 cm from the abutment | 16 Participants |
| Minimally Invasive Surgery and BA400 | Max Numbness | Max Numbness 36 months | Numbness within and beyond 2 cm from the abutment | 8 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 36 months | Numbness within 2 cm from the abutment | 12 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 12 months | No numbness | 9 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 36 months | No numbness | 9 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 12 months | Numbness within 2 cm from the abutment | 12 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 36 months | Numbness within and beyond 2 cm from the abutment | 31 Participants |
| Traditional Surgery and BA300 | Max Numbness | Max Numbness 12 months | Numbness within and beyond 2 cm from the abutment | 31 Participants |
Comparison: maximum numbness at 12 monthsp-value: <0.0001Mantel Haenszel
Comparison: maximum numbness at 36 monthsp-value: <0.0001Mantel Haenszel
Secondary
Pain by Visit - Categorical
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much. Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'.
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Scar pain | 1: No Pain | 25 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Scar pain | 4-6: Moderate Pain | 4 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Scar pain | 2-3: Mild Pain | 16 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Scar pain | 7-10: Severe Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Scar pain | 4-6: Moderate Pain | 5 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Scar pain | 7-10: Severe Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Scar pain | 7-10: Severe Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 1: No Pain | 43 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 1: No Pain | 44 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 1: No Pain | 46 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 2-3: Mild Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 1: No Pain | 44 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 4-6: Moderate Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 2-3: Mild Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 7-10: Severe Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Scar pain | 1: No Pain | 35 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Scar pain | 1: No Pain | 33 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 4-6: Moderate Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Scar pain | 2-3: Mild Pain | 8 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 2-3: Mild Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Scar pain | 4-6: Moderate Pain | 6 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 7-10: Severe Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 24: Scar pain | 7-10: Severe Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 4-6: Moderate Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 1: No Pain | 43 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Scar pain | 1: No Pain | 35 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 2-3: Mild Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 4-6: Moderate Pain | 3 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 4-6: Moderate Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Scar pain | 2-3: Mild Pain | 10 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Scar pain | 2-3: Mild Pain | 10 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Scar pain | 1: No Pain | 30 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Scar pain | 4-6: Moderate Pain | 5 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Scar pain | 2-3: Mild Pain | 11 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Scar pain | 4-6: Moderate Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 6: Scar pain | 7-10: Severe Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 12: Scar pain | 7-10: Severe Pain | 4 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 2-3: Mild Pain | 5 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 1: No Pain | 43 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 1: No Pain | 44 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 2-3: Mild Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Scar pain | 1: No Pain | 33 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 4-6: Moderate Pain | 1 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 2-3: Mild Pain | 3 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 7-10: Severe Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Day 10: Scar pain | 4-6: Moderate Pain | 4 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Scar pain | 1: No Pain | 28 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Scar pain | 2-3: Mild Pain | 12 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 4-6: Moderate Pain | 0 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Scar pain | 4-6: Moderate Pain | 3 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 3: Scar pain | 2-3: Mild Pain | 11 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Month 36: Scar pain | 7-10: Severe Pain | 2 Participants |
| Minimally Invasive Surgery and BA400 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 7-10: Severe Pain | 0 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 4-6: Moderate Pain | 0 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 1: No Pain | 43 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 2-3: Mild Pain | 4 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 4-6: Moderate Pain | 2 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Neuropathic pain | 7-10: Severe Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Scar pain | 1: No Pain | 32 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Scar pain | 2-3: Mild Pain | 10 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Scar pain | 4-6: Moderate Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Day 10: Scar pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 1: No Pain | 36 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 2-3: Mild Pain | 11 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 4-6: Moderate Pain | 4 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Scar pain | 1: No Pain | 34 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Scar pain | 2-3: Mild Pain | 14 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Scar pain | 4-6: Moderate Pain | 4 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 3: Scar pain | 7-10: Severe Pain | 0 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 1: No Pain | 42 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 2-3: Mild Pain | 5 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 4-6: Moderate Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Scar pain | 1: No Pain | 32 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Scar pain | 2-3: Mild Pain | 13 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Scar pain | 4-6: Moderate Pain | 5 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 6: Scar pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 1: No Pain | 36 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 2-3: Mild Pain | 5 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 4-6: Moderate Pain | 5 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Neuropathic pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Scar pain | 1: No Pain | 30 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Scar pain | 2-3: Mild Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Scar pain | 4-6: Moderate Pain | 8 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 12: Scar pain | 7-10: Severe Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 1: No Pain | 41 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 2-3: Mild Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Scar pain | 1: No Pain | 25 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Neuropathic pain | 7-10: Severe Pain | 2 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Scar pain | 1: No Pain | 29 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Scar pain | 2-3: Mild Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Scar pain | 4-6: Moderate Pain | 6 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Week 24: Scar pain | 7-10: Severe Pain | 2 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 1: No Pain | 40 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 2-3: Mild Pain | 1 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 4-6: Moderate Pain | 4 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Neuropathic pain | 7-10: Severe Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Scar pain | 1: No Pain | 31 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Scar pain | 2-3: Mild Pain | 10 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Scar pain | 4-6: Moderate Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 12: Scar pain | 7-10: Severe Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 1: No Pain | 36 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 2-3: Mild Pain | 2 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 4-6: Moderate Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Neuropathic pain | 7-10: Severe Pain | 0 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Scar pain | 2-3: Mild Pain | 10 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Scar pain | 4-6: Moderate Pain | 4 Participants |
| Traditional Surgery and BA300 | Pain by Visit - Categorical | Month 36: Scar pain | 7-10: Severe Pain | 2 Participants |
Comparison: Day 10: Neuropathic painp-value: 0.52Cochran-Mantel-Haenszel
Comparison: Day 10: Scar painp-value: 0.44Cochran-Mantel-Haenszel
Comparison: Week 3: Neuropathic painp-value: 0.14Cochran-Mantel-Haenszel
Comparison: Week 3: Scar painp-value: 0.59Cochran-Mantel-Haenszel
Comparison: Week 6: Neuropathic painp-value: 0.17Cochran-Mantel-Haenszel
Comparison: Week 6: Scar painp-value: 0.44Cochran-Mantel-Haenszel
Comparison: Week 12: Neuropathic painp-value: 0.0087Cochran-Mantel-Haenszel
Comparison: Week 12: Scar painp-value: 0.84Cochran-Mantel-Haenszel
Comparison: Week 24: Neuropathic painp-value: 0.43Cochran-Mantel-Haenszel
Comparison: Week 24: Scar painp-value: 0.33Cochran-Mantel-Haenszel
Comparison: Month 12 Neuropathic painp-value: 0.21Cochran-Mantel-Haenszel
Comparison: Month 12 Scar painp-value: 0.82Cochran-Mantel-Haenszel
Comparison: Month 36 Neuropathic painp-value: 0.19Cochran-Mantel-Haenszel
Comparison: Month 36 Scar painp-value: 0.77Cochran-Mantel-Haenszel
Secondary
Pain in the Scar and Neuropathic Pain
The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Day 10, Neuropathic pain | 1.45 units on a scale | Standard Deviation 1.47 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Day 10, Scar pain | 1.90 units on a scale | Standard Deviation 1.94 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 3, Neuropathic pain | 1.38 units on a scale | Standard Deviation 1.26 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 3, Scar pain | 1.78 units on a scale | Standard Deviation 1.52 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 6, Neuropathic pain | 1.18 units on a scale | Standard Deviation 0.72 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 6, Scar pain | 1.58 units on a scale | Standard Deviation 1.14 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 12, Neuropathic pain | 1.06 units on a scale | Standard Deviation 0.25 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 12, Scar pain | 2.00 units on a scale | Standard Deviation 1.41 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 24, Neuropathic pain | 1.19 units on a scale | Standard Deviation 0.82 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Week 24, Scar pain | 1.70 units on a scale | Standard Deviation 1.25 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Month 12, Neuropathic pain | 1.26 units on a scale | Standard Deviation 1.05 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Month 12, Scar pain | 2.04 units on a scale | Standard Deviation 2.01 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Month 36, Neuropathic pain | 1.11 units on a scale | Standard Deviation 0.53 |
| Minimally Invasive Surgery and BA400 | Pain in the Scar and Neuropathic Pain | Month 36, Scar pain | 1.98 units on a scale | Standard Deviation 1.88 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Month 12, Neuropathic pain | 1.77 units on a scale | Standard Deviation 1.97 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Day 10, Neuropathic pain | 1.65 units on a scale | Standard Deviation 1.75 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 12, Scar pain | 2.06 units on a scale | Standard Deviation 1.63 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Day 10, Scar pain | 2.08 units on a scale | Standard Deviation 1.64 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Month 36, Neuropathic pain | 1.39 units on a scale | Standard Deviation 1.14 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 3, Neuropathic pain | 1.75 units on a scale | Standard Deviation 1.43 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 24, Neuropathic pain | 1.41 units on a scale | Standard Deviation 1.48 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 3, Scar pain | 1.71 units on a scale | Standard Deviation 1.24 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Month 12, Scar pain | 2.02 units on a scale | Standard Deviation 1.93 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 6, Neuropathic pain | 1.45 units on a scale | Standard Deviation 1.19 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 24, Scar pain | 2.02 units on a scale | Standard Deviation 1.72 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 6, Scar pain | 1.80 units on a scale | Standard Deviation 1.34 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Month 36, Scar pain | 2.05 units on a scale | Standard Deviation 1.83 |
| Traditional Surgery and BA300 | Pain in the Scar and Neuropathic Pain | Week 12, Neuropathic pain | 1.70 units on a scale | Standard Deviation 1.53 |
Comparison: Week 3, Neuropathic painp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: Day 10, Neuropathic painp-value: 0.74Wilcoxon (Mann-Whitney)
Comparison: Day 10, Scar painp-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: Week 3, Scar painp-value: 0.92Wilcoxon (Mann-Whitney)
Comparison: Week 6, Neuropathic painp-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Week 6, Scar painp-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Week 12, Neuropathic painp-value: 0.015Wilcoxon (Mann-Whitney)
Comparison: Week 12, Scar painp-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: Week 24, Neuropathic painp-value: 0.44Wilcoxon (Mann-Whitney)
Comparison: Week 24, Scar painp-value: 0.43Wilcoxon (Mann-Whitney)
Comparison: Month 12, Neuropathic painp-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: Month 12, Scar painp-value: 0.97Wilcoxon (Mann-Whitney)
Comparison: Month 36, Neuropathic painp-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Month 36, Scar painp-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.
Time frame: 12 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 1 - No Pain | 34 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 1 - No Pain | 10 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 4-6 - Moderate Pain | 7 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 2-3 - Mild Pain | 22 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 4-6 - Moderate Pain | 12 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 2-3 - Mild Pain | 7 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 7-10 - Severe Pain | 7 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 7-10 - Severe Pain | 3 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 7-10 - Severe Pain | 6 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 1 - No Pain | 27 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 2-3 - Mild Pain | 8 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 4-6 - Moderate Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 7-10 - Severe Pain | 8 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 1 - No Pain | 10 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 4-6 - Moderate Pain | 21 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 2-3 - Mild Pain | 15 Participants |
Comparison: Neuropathic Categorical Max Painp-value: 0.076Mantel Haenszel
Comparison: Scar Categorical Max Painp-value: 0.49Mantel Haenszel
Secondary
Pain - Maximum of Neuropathic and Scar Pain
The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.
Time frame: 36 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 1 - No Pain | 34 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 2-3 - Mild Pain | 7 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 4-6 - Moderate Pain | 7 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 7-10 - Severe Pain | 3 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 1 - No Pain | 9 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 2-3 - Mild Pain | 20 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 4-6 - Moderate Pain | 13 Participants |
| Minimally Invasive Surgery and BA400 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 7-10 - Severe Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 7-10 - Severe Pain | 6 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 1 - No Pain | 27 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 1 - No Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 2-3 - Mild Pain | 8 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 4-6 - Moderate Pain | 23 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 4-6 - Moderate Pain | 9 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Scar Pain | 2-3 - Mild Pain | 14 Participants |
| Traditional Surgery and BA300 | Pain - Maximum of Neuropathic and Scar Pain | Neuropathic Pain | 7-10 - Severe Pain | 8 Participants |
Comparison: Neuropathic Categorical Max Pain 36 monthsp-value: 0.076Mantel Haenszel
Comparison: Scar Categorical Max Pain 36 monthsp-value: 0.71Mantel Haenszel
Secondary
Soft Tissue Thickening/Overgrowth
The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale: 0\. No soft tissue thickening or overgrowth 1. Slight soft tissue thickening or overgrowth 2. Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated\* 3. Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.\* * Should also be reported on the AE page in the CRF
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 6 | No soft tissue thickening | 48 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Day 10 | Slight soft tissue thickening or overgrowth | 2 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Day 10 | Moderate soft tissue thickening or overgrowth | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Day 10 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 3 | No soft tissue thickening | 41 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 3 | Slight soft tissue thickening or overgrowth | 6 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 3 | Moderate soft tissue thickening or overgrowth | 2 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 3 | Marked/distinct soft tissue thickening or overgrow | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Day 10 | No soft tissue thickening | 48 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 6 | Slight soft tissue thickening or overgrowth | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 6 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 6 | Marked/distinct soft tissue thickening or overgrow | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 12 | No soft tissue thickening | 43 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 12 | Slight soft tissue thickening or overgrowth | 4 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 12 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 12 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 24 | No soft tissue thickening | 38 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 24 | Slight soft tissue thickening or overgrowth | 8 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 24 | Moderate soft tissue thickening or overgrowth | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Week 24 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 12 | No soft tissue thickening | 44 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 12 | Slight soft tissue thickening or overgrowth | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 12 | Moderate soft tissue thickening or overgrowth | 3 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 12 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 24 | No soft tissue thickening | 39 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 24 | Slight soft tissue thickening or overgrowth | 6 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 24 | Moderate soft tissue thickening or overgrowth | 1 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 24 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 36 | No soft tissue thickening | 39 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 36 | Slight soft tissue thickening or overgrowth | 6 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 36 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Minimally Invasive Surgery and BA400 | Soft Tissue Thickening/Overgrowth | Month 36 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 36 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Day 10 | No soft tissue thickening | 52 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 24 | No soft tissue thickening | 42 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Day 10 | Slight soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 24 | No soft tissue thickening | 41 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Day 10 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 24 | Slight soft tissue thickening or overgrowth | 4 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Day 10 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 36 | No soft tissue thickening | 37 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 3 | No soft tissue thickening | 50 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 24 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 3 | Slight soft tissue thickening or overgrowth | 2 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 24 | Slight soft tissue thickening or overgrowth | 4 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 3 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 24 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 3 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 36 | Moderate soft tissue thickening or overgrowth | 2 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 6 | No soft tissue thickening | 48 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 12 | No soft tissue thickening | 44 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 6 | Slight soft tissue thickening or overgrowth | 3 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 24 | Moderate soft tissue thickening or overgrowth | 1 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 6 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 12 | Slight soft tissue thickening or overgrowth | 4 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 6 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 36 | Slight soft tissue thickening or overgrowth | 2 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 12 | No soft tissue thickening | 43 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 12 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 12 | Slight soft tissue thickening or overgrowth | 7 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 24 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 12 | Moderate soft tissue thickening or overgrowth | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Month 12 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
| Traditional Surgery and BA300 | Soft Tissue Thickening/Overgrowth | Week 12 | Marked/distinct soft tissue thickening or overgrow | 0 Participants |
Comparison: Day 10 Soft tissue thickening/overgrowthp-value: 0.12Mantel Haenszel
Comparison: Week 3 Soft tissue thickening/overgrowthp-value: 0.016Mantel Haenszel
Comparison: Week 6 Soft tissue thickening/overgrowthp-value: 0.84Mantel Haenszel
Comparison: Week 12 Soft tissue thickening/overgrowthp-value: 0.53Mantel Haenszel
Comparison: Week 24 Soft tissue thickening/overgrowthp-value: 0.18Mantel Haenszel
Comparison: Month 12 Soft tissue thickening/overgrowthp-value: 0.63Mantel Haenszel
Comparison: Month 24 Soft tissue thickening/overgrowthp-value: 0.81Mantel Haenszel
Comparison: Month 36 Soft tissue thickening/overgrowthp-value: 1Mantel Haenszel
Secondary
Surgery Time
Surgery time (minutes) was recorded
Time frame: Day 0
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Surgery Time | 15.3 minutes | Standard Deviation 6.2 |
| Traditional Surgery and BA300 | Surgery Time | 24.7 minutes | Standard Deviation 8.6 |
p-value: <0.0001Mann-Whitney U test
Secondary
The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36.
The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10. The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color). Both patient and observer should also score the overall opinion of the scar on the 1-10 scale. For all above scales 1=normal skin, 10 worst scar imaginable. Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable). The pain not with in the scar variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain
Time frame: Week 12, Months 12 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pliability (observer) | 2.08 units on a scale | Standard Deviation 1.22 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Painful (patient) | 1.98 units on a scale | Standard Deviation 1.88 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Thickness (observer) | 2.02 units on a scale | Standard Deviation 1.52 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Itching (patient) | 2.49 units on a scale | Standard Deviation 2 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pliability (observer) | 1.69 units on a scale | Standard Deviation 1.06 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Itching (patient) | 2.43 units on a scale | Standard Deviation 1.98 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pigmentation (observer) | 1.69 units on a scale | Standard Deviation 1.26 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Itching (patient) | 2.42 units on a scale | Standard Deviation 2.24 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Surface Area (observer) | 2.04 units on a scale | Standard Deviation 1.12 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Color (patient) | 2.32 units on a scale | Standard Deviation 1.49 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Thickness (observer) | 2.02 units on a scale | Standard Deviation 1.31 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Color (patient) | 1.78 units on a scale | Standard Deviation 1.73 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Surface Area (observer) | 1.94 units on a scale | Standard Deviation 1.28 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Color (patient) | 1.80 units on a scale | Standard Deviation 1.96 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Vascularity (observer) | 1.98 units on a scale | Standard Deviation 1.34 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Stiffness (patient) | 2.30 units on a scale | Standard Deviation 1.71 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Surface Area (observer) | 1.98 units on a scale | Standard Deviation 1.11 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Stiffness (patient) | 1.76 units on a scale | Standard Deviation 1.75 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Relief (observer) | 2.11 units on a scale | Standard Deviation 1.18 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Stiffness (patient) | 1.62 units on a scale | Standard Deviation 1.61 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Total Score (observer) | 12.7 units on a scale | Standard Deviation 5.8 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Thickness (patient) | 2.35 units on a scale | Standard Deviation 1.89 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pigmentation (observer) | 1.62 units on a scale | Standard Deviation 1.01 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Thickness (patient) | 1.80 units on a scale | Standard Deviation 1.85 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Total Score (observer) | 11.7 units on a scale | Standard Deviation 6.9 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Thickness (patient) | 2.09 units on a scale | Standard Deviation 1.96 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Relief (observer) | 1.96 units on a scale | Standard Deviation 1.24 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Irregularity (patient) | 2.89 units on a scale | Standard Deviation 2.14 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Total Score (observer) | 10.9 units on a scale | Standard Deviation 5.6 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Irregularity (patient) | 1.87 units on a scale | Standard Deviation 1.78 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pigmentation (observer) | 1.96 units on a scale | Standard Deviation 1.16 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Irregularity (patient) | 1.89 units on a scale | Standard Deviation 1.9 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Overall Opinion (observer) | 2.28 units on a scale | Standard Deviation 1.24 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Total Score (patient) | 13.3 units on a scale | Standard Deviation 7.6 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Relief (observer) | 1.93 units on a scale | Standard Deviation 1.18 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Total Score (patient) | 11.7 units on a scale | Standard Deviation 9.5 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Overall Opinion (observer) | 2.00 units on a scale | Standard Deviation 1.29 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Total Score (patient) | 11.8 units on a scale | Standard Deviation 10.1 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Thickness (observer) | 2.26 units on a scale | Standard Deviation 1.71 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Overall Opinion (patient) | 2.33 units on a scale | Standard Deviation 1.69 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Overall Opinion (observer) | 1.93 units on a scale | Standard Deviation 1.05 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Overall Opinion (patient) | 1.80 units on a scale | Standard Deviation 1.31 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pliability (observer) | 2.21 units on a scale | Standard Deviation 1.1 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Overall Opinion (patient) | 1.82 units on a scale | Standard Deviation 1.65 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Painful (patient) | 2.00 units on a scale | Standard Deviation 1.41 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pain not within Scar (patient) | 1.00 units on a scale | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Vascularity (observer) | 1.69 units on a scale | Standard Deviation 1.33 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pain not within Scar (patient) | 1.09 units on a scale | Standard Deviation 0.58 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Painful (patient) | 2.04 units on a scale | Standard Deviation 2.01 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pain not within Scar (patient) | 1.00 units on a scale | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Vascularity (observer) | 2.11 units on a scale | Standard Deviation 1.15 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pain not within Scar (patient) | 1.27 units on a scale | Standard Deviation 1.03 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Vascularity (observer) | 2.81 units on a scale | Standard Deviation 1.54 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Vascularity (observer) | 2.28 units on a scale | Standard Deviation 1.48 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Vascularity (observer) | 2.13 units on a scale | Standard Deviation 1.49 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pigmentation (observer) | 2.21 units on a scale | Standard Deviation 1.27 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pigmentation (observer) | 1.91 units on a scale | Standard Deviation 1.21 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pigmentation (observer) | 2.03 units on a scale | Standard Deviation 1.61 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Thickness (observer) | 3.25 units on a scale | Standard Deviation 1.49 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Thickness (observer) | 2.72 units on a scale | Standard Deviation 1.99 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Thickness (observer) | 2.63 units on a scale | Standard Deviation 1.85 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Relief (observer) | 3.15 units on a scale | Standard Deviation 1.56 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Relief (observer) | 2.74 units on a scale | Standard Deviation 1.87 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Relief (observer) | 2.80 units on a scale | Standard Deviation 1.86 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pliability (observer) | 3.23 units on a scale | Standard Deviation 1.75 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pliability (observer) | 2.66 units on a scale | Standard Deviation 1.7 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Pliability (observer) | 2.58 units on a scale | Standard Deviation 1.6 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Surface Area (observer) | 3.06 units on a scale | Standard Deviation 1.34 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Surface Area (observer) | 2.68 units on a scale | Standard Deviation 1.7 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Surface Area (observer) | 2.68 units on a scale | Standard Deviation 1.62 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Total Score (observer) | 17.7 units on a scale | Standard Deviation 7.4 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Total Score (observer) | 15.0 units on a scale | Standard Deviation 9 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Total Score (observer) | 14.8 units on a scale | Standard Deviation 8.9 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Overall Opinion (observer) | 3.02 units on a scale | Standard Deviation 1.22 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Overall Opinion (observer) | 2.60 units on a scale | Standard Deviation 1.65 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Overall Opinion (observer) | 2.43 units on a scale | Standard Deviation 1.52 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Painful (patient) | 2.06 units on a scale | Standard Deviation 1.63 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Painful (patient) | 2.02 units on a scale | Standard Deviation 1.93 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Painful (patient) | 2.05 units on a scale | Standard Deviation 1.83 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Itching (patient) | 2.63 units on a scale | Standard Deviation 2.07 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Itching (patient) | 2.45 units on a scale | Standard Deviation 2.09 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Itching (patient) | 2.39 units on a scale | Standard Deviation 2.07 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Color (patient) | 2.06 units on a scale | Standard Deviation 1.29 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Color (patient) | 1.52 units on a scale | Standard Deviation 1.24 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Color (patient) | 1.58 units on a scale | Standard Deviation 1.63 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Stiffness (patient) | 2.47 units on a scale | Standard Deviation 1.68 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Stiffness (patient) | 1.87 units on a scale | Standard Deviation 1.57 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Stiffness (patient) | 2.05 units on a scale | Standard Deviation 1.6 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Thickness (patient) | 2.60 units on a scale | Standard Deviation 1.64 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Thickness (patient) | 1.89 units on a scale | Standard Deviation 1.62 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Thickness (patient) | 2.13 units on a scale | Standard Deviation 1.68 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Irregularity (patient) | 3.27 units on a scale | Standard Deviation 2.07 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Irregularity (patient) | 2.00 units on a scale | Standard Deviation 1.68 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Irregularity (patient) | 2.35 units on a scale | Standard Deviation 1.97 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Total Score (patient) | 15.1 units on a scale | Standard Deviation 6.5 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Total Score (patient) | 11.9 units on a scale | Standard Deviation 8.1 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Total Score (patient) | 12.6 units on a scale | Standard Deviation 8.7 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Overall Opinion (patient) | 2.81 units on a scale | Standard Deviation 2.13 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Overall Opinion (patient) | 2.15 units on a scale | Standard Deviation 1.53 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 36: Overall Opinion (patient) | 2.23 units on a scale | Standard Deviation 1.79 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Week 12: Pain not within Scar (patient) | 1.62 units on a scale | Standard Deviation 1.5 |
| Traditional Surgery and BA300 | The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36. | Month 12: Pain not within Scar (patient) | 1.67 units on a scale | Standard Deviation 1.92 |
Comparison: Week 12: Vascularity (observer)p-value: 0.026Wilcoxon (Mann-Whitney)
Comparison: Month 12: Vascularity (observer)p-value: 0.33Wilcoxon (Mann-Whitney)
Comparison: Month 36: Vascularity (observer)p-value: 0.094Wilcoxon (Mann-Whitney)
Comparison: Week 12: Pigmentation (observer)p-value: 0.3Wilcoxon (Mann-Whitney)
Comparison: Month 12: Pigmentation (observer)p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Month 36: Pigmentation (observer)p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Week 12: Thickness (observer)p-value: 0.0003Wilcoxon (Mann-Whitney)
Comparison: Month 12: Thickness (observer)p-value: 0.062Wilcoxon (Mann-Whitney)
Comparison: Month 36: Thickness (observer)p-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Week 12: Relief (observer)p-value: 0.0003Wilcoxon (Mann-Whitney)
Comparison: Month 12: Relief (observer)p-value: 0.079Wilcoxon (Mann-Whitney)
Comparison: Month 36: Relief (observer)p-value: 0.025Wilcoxon (Mann-Whitney)
Comparison: Week 12: Pliability (observer)p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: Month 12: Pliability (observer)p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Month 36: Pliability (observer)p-value: 0.0014Wilcoxon (Mann-Whitney)
Comparison: Week 12: Surface Area (observer)p-value: 0.0001Wilcoxon (Mann-Whitney)
Comparison: Month 12: Surface Area (observer)p-value: 0.023Wilcoxon (Mann-Whitney)
Comparison: Month 36: Surface Area (observer)p-value: 0.045Wilcoxon (Mann-Whitney)
Comparison: Week 12: Total Score (observer)p-value: 0.0005Wilcoxon (Mann-Whitney)
Comparison: Month 12: Total Score (observer)p-value: 0.085Wilcoxon (Mann-Whitney)
Comparison: Month 36: Total Score (observer)p-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: Week 12: Overall Opinion (observer)p-value: 0.0015Wilcoxon (Mann-Whitney)
Comparison: Month 12: Overall Opinion (observer)p-value: 0.076Wilcoxon (Mann-Whitney)
Comparison: Month 36: Overall Opinion (observer)p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Week 12: Painful (patient)p-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: Month 12: Painful (patient)p-value: 0.97Wilcoxon (Mann-Whitney)
Comparison: Month 36: Painful (patient)p-value: 0.82Wilcoxon (Mann-Whitney)
Comparison: Week 12: Itching (patient)p-value: 0.86Wilcoxon (Mann-Whitney)
Comparison: Month 12: Itching (patient)p-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: Month 36: Itching (patient)p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Week 12: Color (patient)p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Month 12: Color (patient)p-value: 0.98Wilcoxon (Mann-Whitney)
Comparison: Month 36: Color (patient)p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Week 12: Stiffness (patient)p-value: 0.43Wilcoxon (Mann-Whitney)
Comparison: Month 12: Stiffness (patient)p-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Month 36: Stiffness (patient)p-value: 0.017Wilcoxon (Mann-Whitney)
Comparison: Week 12: Thickness (patient)p-value: 0.13Wilcoxon (Mann-Whitney)
Comparison: Month 12: Thickness (patient)p-value: 0.33Wilcoxon (Mann-Whitney)
Comparison: Month 36: Thickness (patient)p-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: Week 12: Irregularity (patient)p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Month 12: Irregularity (patient)p-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Month 36: Irregularity (patient)p-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Week 12: Total Score (patient)p-value: 0.28Wilcoxon (Mann-Whitney)
Comparison: Month 12: Total Score (patient)p-value: 0.44Wilcoxon (Mann-Whitney)
Comparison: Month 36: Total Score (patient)p-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Week 12: Overall Opinion (patient)p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Week 12: Overall Opinion (patient)p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Month 36: Overall Opinion (patient)p-value: 0.079Wilcoxon (Mann-Whitney)
Comparison: Week 12: Pain not within Scar (patient)p-value: 0.0018Wilcoxon (Mann-Whitney)
Comparison: Month 12: Pain not within Scar (patient)p-value: 0.053Wilcoxon (Mann-Whitney)
Comparison: Month 36: Pain not within Scar (patient)p-value: 0.068Wilcoxon (Mann-Whitney)
Secondary
Visible Abutment Length by Visit for Patients With no Change of Abutment
The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant. In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment
Time frame: Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 Month 36.~This analysis is performed on subjects with no change of abutment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Day 10 | 3.30 millimeters visible abutment length | Standard Deviation 1.23 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 3 | 3.34 millimeters visible abutment length | Standard Deviation 1.18 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 6 | 4.00 millimeters visible abutment length | Standard Deviation 1.3 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 12 | 3.73 millimeters visible abutment length | Standard Deviation 1.35 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 24 | 4.07 millimeters visible abutment length | Standard Deviation 1.55 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 12 | 4.33 millimeters visible abutment length | Standard Deviation 1.52 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 24 | 3.90 millimeters visible abutment length | Standard Deviation 1.61 |
| Minimally Invasive Surgery and BA400 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 36 | 3.74 millimeters visible abutment length | Standard Deviation 1.43 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 36 | 3.35 millimeters visible abutment length | Standard Deviation 1.38 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Day 10 | 4.17 millimeters visible abutment length | Standard Deviation 1.13 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 24 | 3.76 millimeters visible abutment length | Standard Deviation 1.26 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 3 | 3.91 millimeters visible abutment length | Standard Deviation 1.04 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 24 | 3.56 millimeters visible abutment length | Standard Deviation 1.25 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 6 | 3.85 millimeters visible abutment length | Standard Deviation 1.13 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Month 12 | 3.72 millimeters visible abutment length | Standard Deviation 1.2 |
| Traditional Surgery and BA300 | Visible Abutment Length by Visit for Patients With no Change of Abutment | Week 12 | 3.51 millimeters visible abutment length | Standard Deviation 1.27 |
Comparison: Visible Abutment Length Day 10p-value: 0.0009Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Week 3p-value: 0.008Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Week 6p-value: 0.46Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Week 12p-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Week 24p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Month 12p-value: 0.017Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Month 24p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Visible Abutment Length Month 36p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: Change in Visible Test Abutment - Week 3 change from day 10p-value: 0.74Sign test
Comparison: Change in Visible Test Abutment - Week 6 change from day 10p-value: <0.0001Sign test
Comparison: Change in Visible Test Abutment - Week 12 change from day 10p-value: 0.041Sign test
Comparison: Change in Visible Test Abutment - Week 24 change from day 10p-value: 0.0065Sign test
Comparison: Change in Visible Test Abutment - Month 12 change from day 10p-value: 0.0003Sign test
Comparison: Change in Visible Test Abutment - Month 24 change from day 10p-value: 0.028Sign test
Comparison: Change in Visible Test Abutment - Month 36 change from day 10p-value: 0.037Sign test
Comparison: Change in Visible Control Abutment - Week 3 change from day 10p-value: 0.072Sign test
Comparison: Change in Visible Control Abutment - Week 6 change from day 10p-value: 0.034Sign test
Comparison: Change in Visible Control Abutment - Week 12 change from day 10p-value: <0.0001Sign test
Comparison: Change in Visible Control Abutment - Week 24 change from day 10p-value: 0.01Sign test
Comparison: Change in Visible Control Abutment - Month 12 change from day 10p-value: 0.0086Sign test
Comparison: Change in Visible Control Abutment - Month 24 change from day 10p-value: 0.0021Sign test
Comparison: Change in Visible Control Abutment - Month 36 change from day 10p-value: 0.0005Sign test
Secondary
Wound Healing
A surgeon or a surgical nurse determined if the wound was healed or not healed.
Time frame: Day 10, Weeks 3, 6, 12 and 24
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Wound Healing | Day 10, Wound healed | 47 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 6, Wound not healed | 3 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Day 10, Wound not healed | 4 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 6, Wound healed | 47 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 12, Wound healed | 46 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 3, Wound not healed | 4 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 24, Wound not healed | 0 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 12, Wound not healed | 1 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 24, Wound healed | 47 participants |
| Minimally Invasive Surgery and BA400 | Wound Healing | Week 3, Wound healed | 46 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 24, Wound healed | 46 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 12, Wound not healed | 0 participants |
| Traditional Surgery and BA300 | Wound Healing | Day 10, Wound not healed | 14 participants |
| Traditional Surgery and BA300 | Wound Healing | Day 10, Wound healed | 38 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 3, Wound not healed | 8 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 3, Wound healed | 44 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 6, Wound not healed | 3 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 12, Wound healed | 50 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 24, Wound not healed | 0 participants |
| Traditional Surgery and BA300 | Wound Healing | Week 6, Wound healed | 48 participants |
Comparison: Day 10p-value: 0.02Fisher Exact
Comparison: Week 3p-value: 0.4Fisher Exact
Comparison: Week 6p-value: 1Fisher Exact
Comparison: Week 12p-value: 0.97Fisher Exact
Comparison: Week 24p-value: 1Fisher Exact
Other Pre-specified
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. The subjects will complete the APHAB at pre-surgery, week 24, month 12 and 36. Questions assess 'Ease of Communication', 'Background Noise', 'Reverberation', 'Aversiveness', and 'Global' in the aided and unaided situations. The aided situation was compared to the unaided situation at baseline (pre-surgery). For each subscale, a score of 99 indicates that there is 'always' difficulty, and a score of 1 indicated that there is 'never' difficulty for that particular subscale.
Time frame: Pre-surgery (baseline) to 24 weeks, 12 and 36 months
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Aided) | 17.5 units on a scale | Standard Deviation 18 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Unaided) | 32.2 units on a scale | Standard Deviation 24.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Background Noise (Aided) | 29.9 units on a scale | Standard Deviation 14.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Aided) | 30.5 units on a scale | Standard Deviation 13.7 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Aided) | 31.8 units on a scale | Standard Deviation 16.5 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Aided) | 42.5 units on a scale | Standard Deviation 16.3 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Aversiveness (Aided) | 39.3 units on a scale | Standard Deviation 23 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Aided) | 29.4 units on a scale | Standard Deviation 12.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Aided) | 26.7 units on a scale | Standard Deviation 13.5 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Unaided) | 56.9 units on a scale | Standard Deviation 20.9 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Unaided) | 41.8 units on a scale | Standard Deviation 27.5 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Aided) | 42.9 units on a scale | Standard Deviation 21.9 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month12: Background Noise (Unaided) | 65.0 units on a scale | Standard Deviation 20.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Unaided) | 45.5 units on a scale | Standard Deviation 30.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Unaided) | 53.4 units on a scale | Standard Deviation 20 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Aided) | 26.7 units on a scale | Standard Deviation 13 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month12: Aversiveness (Unaided) | 30.2 units on a scale | Standard Deviation 21.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Benefit) | 22.1 units on a scale | Standard Deviation 31.5 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Unaided) | 53.7 units on a scale | Standard Deviation 20.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Unaided) | 44.2 units on a scale | Standard Deviation 26.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Benefit) | 41.8 units on a scale | Standard Deviation 27.5 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Aided) | 35.5 units on a scale | Standard Deviation 20 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Background Noise (Benefit) | 65.0 units on a scale | Standard Deviation 20.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Unaided) | 66.5 units on a scale | Standard Deviation 17.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Benefit) | 53.4 units on a scale | Standard Deviation 20 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Benefit) | 29.9 units on a scale | Standard Deviation 24.3 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Aversiveness (Benefit) | 30.2 units on a scale | Standard Deviation 21.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Unaided) | 57.1 units on a scale | Standard Deviation 21.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Benefit) | 53.7 units on a scale | Standard Deviation 20.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Unaided) | 66.6 units on a scale | Standard Deviation 18.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Aided) | 19.3 units on a scale | Standard Deviation 21.3 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Unaided) | 29.6 units on a scale | Standard Deviation 22.3 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Aided) | 33.5 units on a scale | Standard Deviation 16.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Benefit) | 22.7 units on a scale | Standard Deviation 20.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Aided) | 32.7 units on a scale | Standard Deviation 18.2 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Unaided) | 55.9 units on a scale | Standard Deviation 18.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Aided) | 36.2 units on a scale | Standard Deviation 24.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Aided) | 48.9 units on a scale | Standard Deviation 15.9 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Aided) | 28.5 units on a scale | Standard Deviation 15.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Benefit) | 29.3 units on a scale | Standard Deviation 30.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Unaided) | 45.9 units on a scale | Standard Deviation 23.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Benefit) | -12.3 units on a scale | Standard Deviation 24.9 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Unaided) | 66.5 units on a scale | Standard Deviation 19.4 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Benefit) | 37.8 units on a scale | Standard Deviation 22.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Unaided) | 60.4 units on a scale | Standard Deviation 21.1 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Unaided) | 58.6 units on a scale | Standard Deviation 24.7 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Unaided) | 38.5 units on a scale | Standard Deviation 23 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Benefit) | 31.5 units on a scale | Standard Deviation 24.1 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Unaided) | 57.7 units on a scale | Standard Deviation 18.1 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Benefit) | 25.3 units on a scale | Standard Deviation 20.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Benefit) | 27.6 units on a scale | Standard Deviation 36.6 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Benefit) | -10.7 units on a scale | Standard Deviation 31.2 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Benefit) | 32.8 units on a scale | Standard Deviation 21.1 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Aided) | 40.8 units on a scale | Standard Deviation 17 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Benefit) | 27.8 units on a scale | Standard Deviation 26.8 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Benefit) | 32.9 units on a scale | Standard Deviation 21 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Benefit) | -2.22 units on a scale | Standard Deviation 31.71 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Aided) | 20.1 units on a scale | Standard Deviation 21 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Benefit) | 29.4 units on a scale | Standard Deviation 23.1 |
| Minimally Invasive Surgery and BA400 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Aided) | 33.9 units on a scale | Standard Deviation 22.6 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Benefit) | 35.5 units on a scale | Standard Deviation 22.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Aided) | 21.1 units on a scale | Standard Deviation 17.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Aided) | 35.5 units on a scale | Standard Deviation 23.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Aided) | 33.9 units on a scale | Standard Deviation 20.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Aided) | 46.4 units on a scale | Standard Deviation 22.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Aided) | 30.2 units on a scale | Standard Deviation 17.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Unaided) | 55.4 units on a scale | Standard Deviation 26.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Unaided) | 67.4 units on a scale | Standard Deviation 19.1 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Unaided) | 63.0 units on a scale | Standard Deviation 25.4 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Unaided) | 25.7 units on a scale | Standard Deviation 19.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Unaided) | 61.9 units on a scale | Standard Deviation 20.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Ease of Communication (Benefit) | 39.9 units on a scale | Standard Deviation 26.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Background Noise (Benefit) | 42.0 units on a scale | Standard Deviation 26.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Reverberation (Benefit) | 35.9 units on a scale | Standard Deviation 29.4 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Aversiveness (Benefit) | -23.7 units on a scale | Standard Deviation 24.1 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline: Global (Benefit) | 39.2 units on a scale | Standard Deviation 21.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Aided) | 25.7 units on a scale | Standard Deviation 24.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Aided) | 33.0 units on a scale | Standard Deviation 20.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Aided) | 34.9 units on a scale | Standard Deviation 19.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Aided) | 44.7 units on a scale | Standard Deviation 26.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Aided) | 31.1 units on a scale | Standard Deviation 18.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Unaided) | 52.8 units on a scale | Standard Deviation 28.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Unaided) | 65.3 units on a scale | Standard Deviation 19.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Unaided) | 63.2 units on a scale | Standard Deviation 19.6 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Unaided) | 18.3 units on a scale | Standard Deviation 17.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Unaided) | 60.4 units on a scale | Standard Deviation 19.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Ease of Communication (Benefit) | 30.6 units on a scale | Standard Deviation 36.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Background Noise (Benefit) | 37.6 units on a scale | Standard Deviation 22.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Reverberation (Benefit) | 32.4 units on a scale | Standard Deviation 32.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Aversiveness (Benefit) | -20.4 units on a scale | Standard Deviation 25.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Week 24: Global (Benefit) | 33.5 units on a scale | Standard Deviation 26.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Aided) | 19.7 units on a scale | Standard Deviation 18.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Background Noise (Aided) | 32.3 units on a scale | Standard Deviation 14.1 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Aided) | 30.9 units on a scale | Standard Deviation 14 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Aversiveness (Aided) | 37.4 units on a scale | Standard Deviation 28.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Aided) | 27.6 units on a scale | Standard Deviation 12.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Unaided) | 52.0 units on a scale | Standard Deviation 28.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month12: Background Noise (Unaided) | 64.1 units on a scale | Standard Deviation 19.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Unaided) | 60.9 units on a scale | Standard Deviation 20 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month12: Aversiveness (Unaided) | 23.5 units on a scale | Standard Deviation 20.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Unaided) | 58.7 units on a scale | Standard Deviation 19.9 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Ease of Communication (Benefit) | 52.0 units on a scale | Standard Deviation 28.5 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Background Noise (Benefit) | 64.1 units on a scale | Standard Deviation 19.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Reverberation (Benefit) | 60.9 units on a scale | Standard Deviation 20 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Aversiveness (Benefit) | 23.5 units on a scale | Standard Deviation 20.7 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 12: Global (Benefit) | 58.7 units on a scale | Standard Deviation 19.9 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Aided) | 18.1 units on a scale | Standard Deviation 20.1 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Aided) | 35.7 units on a scale | Standard Deviation 17.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Aided) | 30.6 units on a scale | Standard Deviation 13.9 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Aided) | 36.9 units on a scale | Standard Deviation 25.9 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Aided) | 28.1 units on a scale | Standard Deviation 14.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Unaided) | 50.0 units on a scale | Standard Deviation 23.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Unaided) | 62.9 units on a scale | Standard Deviation 18.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Unaided) | 56.6 units on a scale | Standard Deviation 19.6 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Unaided) | 26.1 units on a scale | Standard Deviation 20.8 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Global (Unaided) | 56.5 units on a scale | Standard Deviation 17.3 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Ease of Communication (Benefit) | 38.5 units on a scale | Standard Deviation 28 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Background Noise (Benefit) | 33.9 units on a scale | Standard Deviation 22.2 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Reverberation (Benefit) | 34.2 units on a scale | Standard Deviation 30.6 |
| Traditional Surgery and BA300 | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Month 36: Aversiveness (Benefit) | -9.19 units on a scale | Standard Deviation 32.95 |
Comparison: Baseline: Ease of Communication (Aided)p-value: 0.047Wilcoxon (Mann-Whitney)
Comparison: Baseline: Background Noise (Aided)p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Baseline: Reverberation (Aided)p-value: 0.015Wilcoxon (Mann-Whitney)
Comparison: Baseline: Aversiveness (Aided)p-value: 0.13Wilcoxon (Mann-Whitney)
Comparison: Baseline: Global (Aided)p-value: 0.041Wilcoxon (Mann-Whitney)
Comparison: Baseline: Ease of Communication (Unaided)p-value: 0.071Wilcoxon (Mann-Whitney)
Comparison: Baseline: Background Noise (Unaided)p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Baseline: Reverberation (Unaided)p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: Baseline: Aversiveness (Unaided)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Baseline: Global (Unaided)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Baseline: Ease of Communication (Benefit)p-value: 0.12Wilcoxon (Mann-Whitney)
Comparison: Baseline: Background Noise (Benefit)p-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Baseline: Reverberation (Benefit)p-value: 0.055Wilcoxon (Mann-Whitney)
Comparison: Baseline: Aversiveness (Benefit)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Baseline: Global (Benefit)p-value: 0.042Wilcoxon (Mann-Whitney)
Comparison: Week 24: Ease of Communication (Aided)p-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Week 24: Background Noise (Aided)p-value: 0.99Wilcoxon (Mann-Whitney)
Comparison: Week 24: Reverberation (Aided)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Week 24: Aversiveness (Aided)p-value: 0.73Wilcoxon (Mann-Whitney)
Comparison: Week 24: Global (Aided)p-value: 0.39Wilcoxon (Mann-Whitney)
Comparison: Week 24: Ease of Communication (Unaided)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Week 24: Background Noise (Unaided)p-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: Week 24: Reverberation (Unaided)p-value: 0.34Wilcoxon (Mann-Whitney)
Comparison: Week 24: Aversiveness (Unaided)p-value: 0.038Wilcoxon (Mann-Whitney)
Comparison: Week 24: Global (Unaided)p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: Week 24: Ease of Communication (Benefit)p-value: 0.63Wilcoxon (Mann-Whitney)
Comparison: Week 24: Background Noise (Benefit)p-value: 0.83Wilcoxon (Mann-Whitney)
Comparison: Week 24: Reverberation (Benefit)p-value: 0.71Wilcoxon (Mann-Whitney)
Comparison: Week 24: Aversiveness (Benefit)p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: Week 24: Global (Benefit)p-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: Month 12: Ease of Communication (Aided)p-value: 0.51Wilcoxon (Mann-Whitney)
Comparison: Month 12: Background Noise (Aided)p-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: Month 12: Reverberation (Aided)p-value: 0.93Wilcoxon (Mann-Whitney)
Comparison: Month 12: Aversiveness (Aided)p-value: 0.62Wilcoxon (Mann-Whitney)
Comparison: Month 12: Global (Aided)p-value: 0.63Wilcoxon (Mann-Whitney)
Comparison: Month 12: Ease of Communication (Unaided)p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Month 12: Background Noise (Unaided)p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Month 12: Reverberation (Unaided)p-value: 0.17Wilcoxon (Mann-Whitney)
Comparison: Month 12: Aversiveness (Unaided)p-value: 0.29Wilcoxon (Mann-Whitney)
Comparison: Month 12: Global (Unaided)p-value: 0.4Wilcoxon (Mann-Whitney)
Comparison: Month 12: Ease of Communication (Benefit)p-value: 0.29Wilcoxon (Mann-Whitney)
Comparison: Month 12: Background Noise (Benefit)p-value: 0.9Wilcoxon (Mann-Whitney)
Comparison: Month 12: Reverberation (Benefit)p-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: Month 12: Aversiveness (Benefit)p-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Month 12: Global (Benefit)p-value: 0.37Wilcoxon (Mann-Whitney)
Comparison: Month 36: Ease of Communication (Aided)p-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: Month 36: Background Noise (Aided)p-value: 0.57Wilcoxon (Mann-Whitney)
Comparison: Month 36: Reverberation (Aided)p-value: 0.71Wilcoxon (Mann-Whitney)
Comparison: Month 36: Aversiveness (Aided)p-value: 0.99Wilcoxon (Mann-Whitney)
Comparison: Month 36: Global (Aided)p-value: 0.78Wilcoxon (Mann-Whitney)
Comparison: Month 36: Ease of Communication (Unaided)p-value: 0.5Wilcoxon (Mann-Whitney)
Comparison: Month 36: Background Noise (Unaided)p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Month 36: Reverberation (Unaided)p-value: 0.64Wilcoxon (Mann-Whitney)
Comparison: Month 36: Aversiveness (Unaided)p-value: 0.041Wilcoxon (Mann-Whitney)
Comparison: Month 36: Global (Unaided)p-value: 0.89Wilcoxon (Mann-Whitney)
Comparison: Month 36: Ease of Communication (Benefit)p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Month 36: Background Noise (Benefit)p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Month 36: Reverberation (Benefit)p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Month 36: Aversiveness (Benefit)p-value: 0.57Wilcoxon (Mann-Whitney)
Comparison: Month 36: Global (Benefit)p-value: 0.21Wilcoxon (Mann-Whitney)
Other Pre-specified
Health Utilies Index (HUI-III & HUI-II)
Health Utilities Index (HUI) is a generic preference-based system for measuring comprehensive health status and health-related quality of life. Each index provides descriptive evidence on multiple dimensions of life quality. HUI3: Comprehensive Health State, Vision, Hearing, Speech, Ambulation, Emotion, Cognition, Pain. HUI2: Comprehensive Health State, Sensation, Mobility, Emotion, Cognition, Self Care, Pain. Subjects completed HUI2/3 questionnaires at visit 1 (baseline), 7 (week 24), 8 (month 12) and 10 (month 36). HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Time frame: baseline (pre-surgery), week 24, months 12 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 month 36.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Emotion (HUI2) | 0.912 units on a scale | Standard Deviation 0.162 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Ambulation (HUI3) | 0.989 units on a scale | Standard Deviation 0.043 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Emotion (HUI2) | 0.916 units on a scale | Standard Deviation 0.138 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Pain (HUI3) | 0.922 units on a scale | Standard Deviation 0.18 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Emotion (HUI2) | 0.918 units on a scale | Standard Deviation 0.126 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Emotion (HUI3) | 0.915 units on a scale | Standard Deviation 0.13 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Emotion (HUI2) | 0.959 units on a scale | Standard Deviation 0.065 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Pain (HUI3) | 0.977 units on a scale | Standard Deviation 0.054 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Cognition (HUI2) | 0.966 units on a scale | Standard Deviation 0.072 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Emotion (HUI3) | 0.950 units on a scale | Standard Deviation 0.073 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Cognition (HUI2) | 0.967 units on a scale | Standard Deviation 0.06 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Comprehensive Health State (HUI2) | 0.799 units on a scale | Standard Deviation 0.186 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Cognition (HUI2) | 0.971 units on a scale | Standard Deviation 0.057 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Speech (HUI3) | 0.975 units on a scale | Standard Deviation 0.078 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Cognition (HUI2) | 0.968 units on a scale | Standard Deviation 0.059 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Comprehensive Health State (HUI2) | 0.853 units on a scale | Standard Deviation 0.114 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Self Care (HUI2) | 0.997 units on a scale | Standard Deviation 0.022 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Cognition (HUI3) | 0.951 units on a scale | Standard Deviation 0.124 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Self Care (HUI2) | 0.997 units on a scale | Standard Deviation 0.022 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Comprehensive Health State (HUI2) | 0.853 units on a scale | Standard Deviation 0.114 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Self Care (HUI2) | 0.997 units on a scale | Standard Deviation 0.022 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Ambulation (HUI3) | 0.990 units on a scale | Standard Deviation 0.053 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Self Care (HUI2) | 1.000 units on a scale | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Comprehensive Health State (HUI2) | 0.896 units on a scale | Standard Deviation 0.081 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Pain (HUI2) | 0.913 units on a scale | Standard Deviation 0.224 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Cognition (HUI3) | 0.966 units on a scale | Standard Deviation 0.074 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Pain (HUI2) | 0.957 units on a scale | Standard Deviation 0.105 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Sensation (HUI2) | 0.687 units on a scale | Standard Deviation 0.264 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Pain (HUI2) | 0.960 units on a scale | Standard Deviation 0.082 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Ambulation (HUI3) | 0.983 units on a scale | Standard Deviation 0.061 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Pain (HUI2) | 0.990 units on a scale | Standard Deviation 0.02 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Sensation (HUI2) | 0.835 units on a scale | Standard Deviation 0.141 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Vision (HUI3) | 0.942 units on a scale | Standard Deviation 0.095 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Comprehensive Health State (HUI3) | 0.617 units on a scale | Standard Deviation 0.272 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Cognition (HUI3) | 0.944 units on a scale | Standard Deviation 0.133 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Comprehensive Health State (HUI3) | 0.705 units on a scale | Standard Deviation 0.173 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Sensation (HUI2) | 0.822 units on a scale | Standard Deviation 0.146 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Comprehensive Health State (HUI3) | 0.688 units on a scale | Standard Deviation 0.206 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Ambulation (HUI3) | 1.000 units on a scale | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Comprehensive Health State (HUI3) | 0.758 units on a scale | Standard Deviation 0.147 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Sensation (HUI2) | 0.828 units on a scale | Standard Deviation 0.148 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Vision (HUI3) | 0.952 units on a scale | Standard Deviation 0.086 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Cognition (HUI3) | 0.966 units on a scale | Standard Deviation 0.074 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Vision (HUI3) | 0.927 units on a scale | Standard Deviation 0.169 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Mobility (HUI2) | 0.987 units on a scale | Standard Deviation 0.058 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Vision (HUI3) | 0.950 units on a scale | Standard Deviation 0.087 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Speech (HUI3) | 0.984 units on a scale | Standard Deviation 0.062 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Mobility (HUI2) | 0.995 units on a scale | Standard Deviation 0.02 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Hearing (HUI3) | 0.627 units on a scale | Standard Deviation 0.304 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Pain (HUI3) | 0.901 units on a scale | Standard Deviation 0.174 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Hearing (HUI3) | 0.756 units on a scale | Standard Deviation 0.082 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Mobility (HUI2) | 0.990 units on a scale | Standard Deviation 0.057 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Hearing (HUI3) | 0.726 units on a scale | Standard Deviation 0.152 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Emotion (HUI3) | 0.893 units on a scale | Standard Deviation 0.17 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Hearing (HUI3) | 0.728 units on a scale | Standard Deviation 0.172 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Mobility (HUI2) | 1.000 units on a scale | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Speech (HUI3) | 0.913 units on a scale | Standard Deviation 0.165 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Pain (HUI3) | 0.933 units on a scale | Standard Deviation 0.12 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Speech (HUI3) | 0.981 units on a scale | Standard Deviation 0.073 |
| Minimally Invasive Surgery and BA400 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Emotion (HUI3) | 0.911 units on a scale | Standard Deviation 0.125 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Speech (HUI3) | 0.989 units on a scale | Standard Deviation 0.055 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Emotion (HUI3) | 0.900 units on a scale | Standard Deviation 0.16 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Speech (HUI3) | 0.975 units on a scale | Standard Deviation 0.078 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Speech (HUI3) | 0.956 units on a scale | Standard Deviation 0.127 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Ambulation (HUI3) | 0.958 units on a scale | Standard Deviation 0.136 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Ambulation (HUI3) | 0.966 units on a scale | Standard Deviation 0.115 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Ambulation (HUI3) | 0.949 units on a scale | Standard Deviation 0.164 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Ambulation (HUI3) | 0.924 units on a scale | Standard Deviation 0.177 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Emotion (HUI3) | 0.945 units on a scale | Standard Deviation 0.108 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Emotion (HUI3) | 0.930 units on a scale | Standard Deviation 0.09 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Emotion (HUI3) | 0.906 units on a scale | Standard Deviation 0.155 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Cognition (HUI3) | 0.948 units on a scale | Standard Deviation 0.144 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Cognition (HUI3) | 0.937 units on a scale | Standard Deviation 0.11 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Cognition (HUI3) | 0.909 units on a scale | Standard Deviation 0.151 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Cognition (HUI3) | 0.935 units on a scale | Standard Deviation 0.108 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Pain (HUI3) | 0.918 units on a scale | Standard Deviation 0.164 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Pain (HUI3) | 0.908 units on a scale | Standard Deviation 0.129 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Pain (HUI3) | 0.899 units on a scale | Standard Deviation 0.215 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Pain (HUI3) | 0.926 units on a scale | Standard Deviation 0.142 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Comprehensive Health State (HUI2) | 0.781 units on a scale | Standard Deviation 0.164 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Comprehensive Health State (HUI2) | 0.862 units on a scale | Standard Deviation 0.099 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Comprehensive Health State (HUI2) | 0.827 units on a scale | Standard Deviation 0.15 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Comprehensive Health State (HUI2) | 0.821 units on a scale | Standard Deviation 0.154 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Sensation (HUI2) | 0.666 units on a scale | Standard Deviation 0.281 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Sensation (HUI2) | 0.849 units on a scale | Standard Deviation 0.066 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Sensation (HUI2) | 0.845 units on a scale | Standard Deviation 0.078 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Sensation (HUI2) | 0.809 units on a scale | Standard Deviation 0.165 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Mobility (HUI2) | 0.972 units on a scale | Standard Deviation 0.093 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Mobility (HUI2) | 0.976 units on a scale | Standard Deviation 0.084 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Mobility (HUI2) | 0.965 units on a scale | Standard Deviation 0.11 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Mobility (HUI2) | 0.961 units on a scale | Standard Deviation 0.105 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Emotion (HUI2) | 0.929 units on a scale | Standard Deviation 0.158 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Emotion (HUI2) | 0.940 units on a scale | Standard Deviation 0.098 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Emotion (HUI2) | 0.901 units on a scale | Standard Deviation 0.14 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Emotion (HUI2) | 0.923 units on a scale | Standard Deviation 0.113 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Cognition (HUI2) | 0.960 units on a scale | Standard Deviation 0.084 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Cognition (HUI2) | 0.956 units on a scale | Standard Deviation 0.066 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Cognition (HUI2) | 0.948 units on a scale | Standard Deviation 0.078 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Cognition (HUI2) | 0.092 units on a scale | Standard Deviation 0.067 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Self Care (HUI2) | 0.994 units on a scale | Standard Deviation 0.03 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Self Care (HUI2) | 0.997 units on a scale | Standard Deviation 0.022 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Self Care (HUI2) | 0.987 units on a scale | Standard Deviation 0.069 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Self Care (HUI2) | 0.993 units on a scale | Standard Deviation 0.033 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Pain (HUI2) | 0.956 units on a scale | Standard Deviation 0.099 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Pain (HUI2) | 0.962 units on a scale | Standard Deviation 0.071 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Pain (HUI2) | 0.941 units on a scale | Standard Deviation 0.146 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Pain (HUI2) | 0.924 units on a scale | Standard Deviation 0.185 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Comprehensive Health State (HUI3) | 0.620 units on a scale | Standard Deviation 0.262 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Comprehensive Health State (HUI3) | 0.671 units on a scale | Standard Deviation 0.196 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Comprehensive Health State (HUI3) | 0.650 units on a scale | Standard Deviation 0.232 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Comprehensive Health State (HUI3) | 0.639 units on a scale | Standard Deviation 0.239 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Vision (HUI3) | 0.964 units on a scale | Standard Deviation 0.023 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Vision (HUI3) | 0.935 units on a scale | Standard Deviation 0.126 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Vision (HUI3) | 0.940 units on a scale | Standard Deviation 0.101 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Vision (HUI3) | 0.929 units on a scale | Standard Deviation 0.115 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Hearing (HUI3) | 0.601 units on a scale | Standard Deviation 0.304 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Week 24: Hearing (HUI3) | 0.716 units on a scale | Standard Deviation 0.089 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 12: Hearing (HUI3) | 0.760 units on a scale | Standard Deviation 0.083 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Month 36: Hearing (HUI3) | 0.683 units on a scale | Standard Deviation 0.197 |
| Traditional Surgery and BA300 | Health Utilies Index (HUI-III & HUI-II) | Baseline: Speech (HUI3) | 0.906 units on a scale | Standard Deviation 0.165 |
Comparison: Baseline: Comprehensive Health State (HUI3)p-value: 0.9Wilcoxon (Mann-Whitney)
Comparison: Week 24: Comprehensive Health State (HUI3)p-value: 0.43Wilcoxon (Mann-Whitney)
Comparison: Month 12: Comprehensive Health State (HUI3)p-value: 0.23Wilcoxon (Mann-Whitney)
Comparison: Month 36: Comprehensive Health State (HUI3)p-value: 0.019Wilcoxon (Mann-Whitney)
Comparison: Baseline: Vision (HUI3)p-value: 0.079Wilcoxon (Mann-Whitney)
Comparison: Week 24: Vision (HUI3)p-value: 0.96Wilcoxon (Mann-Whitney)
Comparison: Month 12: Vision (HUI3)p-value: 0.55Wilcoxon (Mann-Whitney)
Comparison: Month 36: Vision (HUI3)p-value: 0.64Wilcoxon (Mann-Whitney)
Comparison: Baseline: Hearing (HUI3)p-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: Week 24: Hearing (HUI3)p-value: 0.059Wilcoxon (Mann-Whitney)
Comparison: Month 12: Hearing (HUI3)p-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Month 36: Hearing (HUI3)p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Baseline: Speech (HUI3)p-value: 0.73Wilcoxon (Mann-Whitney)
Comparison: Week 24: Speech (HUI3)p-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: Month 12: Speech (HUI3)p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Month 36: Speech (HUI3)p-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: Baseline: Ambulation (HUI3)p-value: 0.5Wilcoxon (Mann-Whitney)
Comparison: Week 24: Ambulation (HUI3)p-value: 0.4Wilcoxon (Mann-Whitney)
Comparison: Month 12: Ambulation (HUI3)p-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: Month 36: Ambulation (HUI3)p-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Baseline: Emotion (HUI3)p-value: 0.13Wilcoxon (Mann-Whitney)
Comparison: Week 24: Emotion (HUI3)p-value: 0.96Wilcoxon (Mann-Whitney)
Comparison: Month 12: Emotion (HUI3)p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Month 36: Emotion (HUI3)p-value: 0.2Wilcoxon (Mann-Whitney)
Comparison: Baseline: Cognition (HUI3)p-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: Week 24: Cognition (HUI3)p-value: 0.31Wilcoxon (Mann-Whitney)
Comparison: Month 12: Cognition (HUI3)p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: Month 36: Cognition (HUI3)p-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Baseline: Pain (HUI3)p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Week 24: Pain (HUI3)p-value: 0.3Wilcoxon (Mann-Whitney)
Comparison: Month 12: Pain (HUI3)p-value: 0.42Wilcoxon (Mann-Whitney)
Comparison: Month 36: Pain (HUI3)p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Baseline: Comprehensive Health State (HUI2)p-value: 0.99Wilcoxon (Mann-Whitney)
Comparison: Week 24: Comprehensive Health State (HUI2)p-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: Month 12: Comprehensive Health State (HUI2)p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: Month 36: Comprehensive Health State (HUI2)p-value: 0.0084Wilcoxon (Mann-Whitney)
Comparison: Baseline: Sensation (HUI2)p-value: 0.77Wilcoxon (Mann-Whitney)
Comparison: Week 24: Sensation (HUI2)p-value: 0.95Wilcoxon (Mann-Whitney)
Comparison: Month 12: Sensation (HUI2)p-value: 0.6Wilcoxon (Mann-Whitney)
Comparison: Month 36: Sensation (HUI2)p-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Baseline: Mobility (HUI2)p-value: 0.51Wilcoxon (Mann-Whitney)
Comparison: Week 24: Mobility (HUI2)p-value: 0.42Wilcoxon (Mann-Whitney)
Comparison: Month 12: Mobility (HUI2)p-value: 0.22Wilcoxon (Mann-Whitney)
Comparison: Month 36: Mobility (HUI2)p-value: 0.0018Wilcoxon (Mann-Whitney)
Comparison: Baseline: Emotion (HUI2)p-value: 0.3Wilcoxon (Mann-Whitney)
Comparison: Week 24: Emotion (HUI2)p-value: 0.52Wilcoxon (Mann-Whitney)
Comparison: Month 12: Emotion (HUI2)p-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: Month 36: Emotion (HUI2)p-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Baseline: Cognition (HUI2)p-value: 0.82Wilcoxon (Mann-Whitney)
Comparison: Week 24: Cognition (HUI2)p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Month 12: Cognition (HUI2)p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Month 36: Cognition (HUI2)p-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Baseline: Self Care (HUI2)p-value: 0.59Wilcoxon (Mann-Whitney)
Comparison: Week 24: Self Care (HUI2)p-value: 1Wilcoxon (Mann-Whitney)
Comparison: Month 12: Self Care (HUI2)p-value: 0.55Wilcoxon (Mann-Whitney)
Comparison: Month 36: Self Care (HUI2)p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: Baseline: Pain (HUI2)p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Week 24: Pain (HUI2)p-value: 0.63Wilcoxon (Mann-Whitney)
Comparison: Month 12: Pain (HUI2)p-value: 0.57Wilcoxon (Mann-Whitney)
Comparison: Month 36: Pain (HUI2)p-value: 0.019Wilcoxon (Mann-Whitney)
Other Pre-specified
Implant Stability (ISQ)
ISQ is a well-established method to measure stability of osseointegrated implants and has been used for several years both for bone conduction implants and for dental implants. Measurements were performed using resonance frequency analysis at the abutment level. The highest and lowest ISQ value out of two perpendicular measurements obtained at each time point was recorded, ISQ High and ISQ Low. The ISQ values ranges from 1 to 100. Overall, the length of test abutments (BA400) were longer than control abutments (BA300) and there is an inverse correlation between abutment length and stability. A direct comparison between the groups is not relevant. Implant Stability Quotient (ISQ) was recorded at surgery as a baseline value and at visit 2-10.
Time frame: Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Surgery: ISQ (High) | 55.4 Implant Stability Quotient | Standard Deviation 6.6 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Surgery: ISQ (Low) | 53.2 Implant Stability Quotient | Standard Deviation 6.7 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Day 10: ISQ (High) | 54.9 Implant Stability Quotient | Standard Deviation 8.7 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Day 10: ISQ (Low) | 52.6 Implant Stability Quotient | Standard Deviation 9.8 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 3: ISQ (High) | 54.6 Implant Stability Quotient | Standard Deviation 9 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 3: ISQ (Low) | 52.2 Implant Stability Quotient | Standard Deviation 9.9 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 6: ISQ (High) | 56.6 Implant Stability Quotient | Standard Deviation 7.3 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 6: ISQ (Low) | 53.3 Implant Stability Quotient | Standard Deviation 9.3 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 12: ISQ (High) | 58.0 Implant Stability Quotient | Standard Deviation 6.3 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 12: ISQ (Low) | 55.6 Implant Stability Quotient | Standard Deviation 6.7 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 24: ISQ (High) | 59.7 Implant Stability Quotient | Standard Deviation 5.4 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Week 24: ISQ (Low) | 57.5 Implant Stability Quotient | Standard Deviation 5.7 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 12: ISQ (High) | 59.6 Implant Stability Quotient | Standard Deviation 5 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 12: ISQ (Low) | 58.0 Implant Stability Quotient | Standard Deviation 4.8 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 24: ISQ (High) | 60.4 Implant Stability Quotient | Standard Deviation 6.1 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 24: ISQ (Low) | 59.0 Implant Stability Quotient | Standard Deviation 6.2 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 36: ISQ (High) | 59.6 Implant Stability Quotient | Standard Deviation 6 |
| Minimally Invasive Surgery and BA400 | Implant Stability (ISQ) | Month 36: ISQ (Low) | 58.2 Implant Stability Quotient | Standard Deviation 5.8 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 12: ISQ (Low) | 65.5 Implant Stability Quotient | Standard Deviation 4.7 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Surgery: ISQ (High) | 66.2 Implant Stability Quotient | Standard Deviation 4.1 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 12: ISQ (Low) | 63.8 Implant Stability Quotient | Standard Deviation 6 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Surgery: ISQ (Low) | 64.1 Implant Stability Quotient | Standard Deviation 4.8 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 36: ISQ (Low) | 62.5 Implant Stability Quotient | Standard Deviation 5.5 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Day 10: ISQ (High) | 63.4 Implant Stability Quotient | Standard Deviation 9.3 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 24: ISQ (High) | 66.8 Implant Stability Quotient | Standard Deviation 4.3 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Day 10: ISQ (Low) | 61.3 Implant Stability Quotient | Standard Deviation 9.7 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 24: ISQ (High) | 66.8 Implant Stability Quotient | Standard Deviation 5.5 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 3: ISQ (High) | 65.2 Implant Stability Quotient | Standard Deviation 5.2 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 24: ISQ (Low) | 64.4 Implant Stability Quotient | Standard Deviation 5.3 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 3: ISQ (Low) | 63.3 Implant Stability Quotient | Standard Deviation 5.8 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 36: ISQ (High) | 67.0 Implant Stability Quotient | Standard Deviation 5.3 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 6: ISQ (High) | 64.6 Implant Stability Quotient | Standard Deviation 6.9 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 12: ISQ (High) | 67.6 Implant Stability Quotient | Standard Deviation 4 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 6: ISQ (Low) | 62.4 Implant Stability Quotient | Standard Deviation 7.9 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Month 24: ISQ (Low) | 66.2 Implant Stability Quotient | Standard Deviation 4.3 |
| Traditional Surgery and BA300 | Implant Stability (ISQ) | Week 12: ISQ (High) | 66.1 Implant Stability Quotient | Standard Deviation 4.9 |
Other Pre-specified
Loss of Implant
'Loss of Implant' refers to the loss of the implant for reasons including failure of implant to osseointegrate, or an implant that was loose form surgery. It does not include elected removal of the device.
Time frame: from surgery through to 36 months
Population: The Safety Population includes all patients who had the surgical treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimally Invasive Surgery and BA400 | Loss of Implant | 1 Participants |
| Traditional Surgery and BA300 | Loss of Implant | 1 Participants |
Comparison: Loss of Implant (safety population)p-value: 0.989Log Rank
Other Pre-specified
Removal of Abutment
Count of subjects who had their abutment removed for reasons of health and safety, such as infection, inflammation or pain.
Time frame: from surgery through to 36 months
Population: The Safety Population includes all patients who had the surgical treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimally Invasive Surgery and BA400 | Removal of Abutment | 2 Participants |
| Traditional Surgery and BA300 | Removal of Abutment | 2 Participants |
Other Pre-specified
Smoking Habits by Visit
Nicotine use and smoking habits were recorded for patients. 1. Does not smoke 2. Less than 10 cigarettes/day (Low consumption) 3. Between 11 and 20 cigarettes/day (Medium consumption) 4. Between 21 and 40 cigarettes/day (High consumption) 5. More than 40 cigarettes/day (Very high consumption) In Sweden a large proportion of adults use another form of tobacco, wet snuff. In Sweden the patients were asked if they used wet snuff.
Time frame: baseline, Weeks 3, 12, Months 12, 24 and 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Yes, Between 21-40 cigarettes/day | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Yes, Less than 10 cigarettes/day | 5 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Yes, Between 11-20 cigarettes/day | 8 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Yes, Between 21-40 cigarettes/day | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Wet Snuff | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | Not answered | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | No Smoking | 36 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Yes, Less than 10 cigarettes/day | 5 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Yes, Between 11-20 cigarettes/day | 7 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Baseline Smoking | No Smoking | 37 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Wet Snuff | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 3 Smoking | Not answered | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | No Smoking | 32 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Yes, Less than 10 cigarettes/day | 8 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Yes, Between 11-20 cigarettes/day | 4 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Yes, Between 21-40 cigarettes/day | 2 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Wet Snuff | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Week 12 Smoking | Not answered | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | No Smoking | 35 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Yes, Less than 10 cigarettes/day | 8 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Yes, Between 11-20 cigarettes/day | 2 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Yes, Between 21-40 cigarettes/day | 2 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Wet Snuff | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 12 Smoking | Not answered | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | No Smoking | 34 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Yes, Less than 10 cigarettes/day | 7 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Yes, Between 11-20 cigarettes/day | 3 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Yes, Between 21-40 cigarettes/day | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Wet Snuff | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 24 Smoking | Not answered | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | No Smoking | 34 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Yes, Less than 10 cigarettes/day | 6 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Yes, Between 11-20 cigarettes/day | 4 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Yes, Between 21-40 cigarettes/day | 1 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Wet Snuff | 0 Participants |
| Minimally Invasive Surgery and BA400 | Smoking Habits by Visit | Month 36 Smoking | Not answered | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Yes, Between 21-40 cigarettes/day | 3 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | No Smoking | 38 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | No Smoking | 33 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Yes, Less than 10 cigarettes/day | 3 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Yes, Between 11-20 cigarettes/day | 8 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Yes, Less than 10 cigarettes/day | 4 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Yes, Between 21-40 cigarettes/day | 2 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Yes, Between 11-20 cigarettes/day | 8 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Yes, Between 11-20 cigarettes/day | 6 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Baseline Smoking | Not answered | 1 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Yes, Between 21-40 cigarettes/day | 3 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | No Smoking | 39 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Yes, Less than 10 cigarettes/day | 4 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Yes, Between 11-20 cigarettes/day | 7 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Not answered | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Yes, Between 21-40 cigarettes/day | 1 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Not answered | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 12 Smoking | Not answered | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 3 Smoking | Not answered | 1 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Yes, Between 21-40 cigarettes/day | 2 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | No Smoking | 38 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | No Smoking | 31 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Yes, Less than 10 cigarettes/day | 4 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | No Smoking | 30 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Yes, Between 11-20 cigarettes/day | 6 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Yes, Less than 10 cigarettes/day | 6 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Yes, Between 21-40 cigarettes/day | 2 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Yes, More than 40 cigarettes/day | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 24 Smoking | Yes, Between 11-20 cigarettes/day | 6 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Wet Snuff | 0 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Month 36 Smoking | Yes, Less than 10 cigarettes/day | 3 Participants |
| Traditional Surgery and BA300 | Smoking Habits by Visit | Week 12 Smoking | Not answered | 0 Participants |
Comparison: Baseline: Smoking and Wet Snuff habitsp-value: 0.91Mantel Haenszel
Comparison: Week 3: Smoking and Wet Snuff habitsp-value: 0.7Mantel Haenszel
Comparison: Week 12: Smoking and Wet Snuff habitsp-value: 0.95Mantel Haenszel
Comparison: Month 12: Smoking and Wet Snuff habitsp-value: 0.22Mantel Haenszel
Comparison: Month 24: Smoking and Wet Snuff habitsp-value: 0.19Mantel Haenszel
Comparison: Month 36: Smoking and Wet Snuff habitsp-value: 0.45Mantel Haenszel
Other Pre-specified
Use of Sound Processor
Use of the sound processor can be seen as a reflection of patient satisfaction and treatment compliance. Patients were asked to record how many hours per week they used the sound processor after Baha loading at week 3.
Time frame: Weeks 6, 12, 24, Months 12, 24, 36
Population: The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 6: No Sound Processor Usage (Patients) | 0 Hours of use per week | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 6: Sound Processor Usage (hours/week) | 80.4 Hours of use per week | Standard Deviation 30.1 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 12: No Sound Processor Usage (Patients) | 2 Hours of use per week | Standard Deviation 4.8 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 12: Sound Processor Usage (hours/week) | 75.2 Hours of use per week | Standard Deviation 33 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 24: No Sound Processor Usage (Patients) | 1 Hours of use per week | Standard Deviation 2.1 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Week 24: Sound Processor Usage (hours/week) | 74.6 Hours of use per week | Standard Deviation 34.1 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 12: No Sound Processor Usage (Patients) | 2 Hours of use per week | Standard Deviation 4.2 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 12: Sound Processor Usage (hours/week) | 73.5 Hours of use per week | Standard Deviation 35.1 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 24: No Sound Processor Usage (Patients) | 2 Hours of use per week | Standard Deviation 4.3 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 24: Sound Processor Usage (hours/week) | 68.3 Hours of use per week | Standard Deviation 36.7 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 36: No Sound Processor Usage (Patients) | 0 Hours of use per week | Standard Deviation 0 |
| Minimally Invasive Surgery and BA400 | Use of Sound Processor | Month 36: Sound Processor Usage (hours/week) | 74.3 Hours of use per week | Standard Deviation 32.2 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 36: No Sound Processor Usage (Patients) | 1 Hours of use per week | Standard Deviation 2.4 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 6: No Sound Processor Usage (Patients) | 0 Hours of use per week | Standard Deviation 0 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 12: No Sound Processor Usage (Patients) | 1 Hours of use per week | Standard Deviation 2.1 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 6: Sound Processor Usage (hours/week) | 83.6 Hours of use per week | Standard Deviation 27.7 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 24: Sound Processor Usage (hours/week) | 72.1 Hours of use per week | Standard Deviation 36.6 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 12: No Sound Processor Usage (Patients) | 1 Hours of use per week | Standard Deviation 2.1 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 12: Sound Processor Usage (hours/week) | 80.1 Hours of use per week | Standard Deviation 29.4 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 12: Sound Processor Usage (hours/week) | 77.9 Hours of use per week | Standard Deviation 29.7 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 36: Sound Processor Usage (hours/week) | 77.7 Hours of use per week | Standard Deviation 32.6 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 24: No Sound Processor Usage (Patients) | 0 Hours of use per week | Standard Deviation 0 |
| Traditional Surgery and BA300 | Use of Sound Processor | Month 24: No Sound Processor Usage (Patients) | 1 Hours of use per week | Standard Deviation 2.3 |
| Traditional Surgery and BA300 | Use of Sound Processor | Week 24: Sound Processor Usage (hours/week) | 78.0 Hours of use per week | Standard Deviation 30.6 |
Comparison: Sound Processor Usage: Week 6p-value: 0.46Wilcoxon (Mann-Whitney)
Comparison: Use of Sound Processor: Week 12p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: Use of Sound Processor: Week 24p-value: 0.83Wilcoxon (Mann-Whitney)
Comparison: Use of Sound Processor: Month 12p-value: 0.52Wilcoxon (Mann-Whitney)
Comparison: Use of Sound Processor: Month 24p-value: 0.67Wilcoxon (Mann-Whitney)
Comparison: Use of Sound Processor: Month 36p-value: 0.71Wilcoxon (Mann-Whitney)