Tibia Fractures
Conditions
Brief summary
This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.
Interventions
DEVICEETN PROtect
Expert Tibial Nail PROtect with Gentamicin coating
Sponsors
Synthes GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 years or more * Open or closed tibia fracture according to the surgical technique
Exclusion criteria
* Women who are pregnant or breast-feeding or are planning to become pregnant during the study * Patients with consumptive/ malignant primary disease and a life expectancy of \< 3 months * Patients with a known allergy to aminoglycosides * Physical or mental incapacity, which makes it impossible to obtain informed consent * History of drug and alcohol abuse * Patient unlikely to cooperate * Legal incompetence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life: SF-12 Physical Component Summary (PCS) | 3, 6, 12 and 18 months post-operatively | The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. |
| Quality of Life: SF-12 Mental Component Summary (MCS) | 3, 6, 12 and 18 months post-operatively | The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively. |
| Quality of Life: EQ-5D | 3, 6, 12 and 18 months post-operatively | The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life. |
| Functional Outcome: IOWA Ankle Score | Baseline, 3, 6, 12 and 18 months post-operatively | The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function. |
| Functional Outcome: WOMAC | 3, 6, 12 and 18 months post-operatively | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations. |
| Infection Adverse Events | 0 - 18 months | Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into: * superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue * deep incisional SSI, affecting deep soft tissue * organ/ space SSI (Osteomyelitis), affecting joint or bursa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain by Visual Analog Scale (VAS) | 6 weeks, 3, 6, 12 and 18 months post-operatively | Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain. |
| Evidence of Anatomic Bone Union According to Johnson Classification | 12 months | Anatomic bone union was assessed according to Johnson et al.\*: A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 |
| Time to Full Weight Bearing | 0 - 18 months | The time from surgery to full weight bearing was assessed in days. |
| Patient's Perceived Satisfaction | 6 months | Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied. |
| Evidence of Economic Bone Union According to Johnson Classification | 12 months | Economic bone union was assessed according to Johnson et al.\*: E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 |
| Evidence of Functional Bone Union According to Johnson Classification | 12 months | Functional bone union was assessed according to Johnson et al.\*: F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57 |
| Surgeon's Perceived Satisfaction | 6 weeks, 3 and 6 months post-operatively | Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed). |
| Likelihood to Develop Wound Infection Assessed by Surgeon | 6 weeks, 3 and 6 months post-operatively | The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). |
| Likelihood to Develop a Non-union Assessed by Surgeon | 6 weeks, 3 and 6 months post-operatively | The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ETN PROtect There is only 1 cohort in this case series.
ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Patient non-compliance | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screening failure | 1 |
Baseline characteristics
| Characteristic | ETN PROtect |
|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 15.6 |
| Allergies Gentamicin | 0 participants |
| Allergies Metal | 2 participants |
| Allergies No or unknown | 74 participants |
| Allergies Other | 23 participants |
| Body Mass Index (BMI) | 26.2 kg/m^2 STANDARD_DEVIATION 5.2 |
| Drinking Drinker | 0 participants |
| Drinking Drinks small amounts (<3 units/day) | 76 participants |
| Drinking Ex-drinker | 1 participants |
| Drinking Never drank | 22 participants |
| Drugs Drug abuser | 0 participants |
| Drugs Ex-drug abuser | 15 participants |
| Drugs Never used drugs | 84 participants |
| Fracture type revision purposes | 31 participants |
| Fracture type traumatic/pathologic | 68 participants |
| Fracture type (open or closed) Closed | 50 participants |
| Fracture type (open or closed) None | 1 participants |
| Fracture type (open or closed) Open | 45 participants |
| Fracture type (open or closed) Unknown | 3 participants |
| Height | 177.6 cm STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 97 participants |
| Race/Ethnicity, Customized Negroid | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants |
| Region of Enrollment Germany | 99 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 73 Participants |
| Smoking No, never smoked | 45 participants |
| Smoking No, quit <= 6 Months ago | 4 participants |
| Smoking No, quit > 6 Months ago | 19 participants |
| Smoking Yes | 31 participants |
| Time from injury to surgery for revision patients | 17.1 months STANDARD_DEVIATION 16.5 |
| Time from injury to surgery for traumatic/pathologic patients | 8.7 days STANDARD_DEVIATION 28.5 |
| Use of systemic antibiotics prophylaxis None | 0 participants |
| Use of systemic antibiotics prophylaxis Peri-Operative | 76 participants |
| Use of systemic antibiotics prophylaxis Post-Operative | 32 participants |
| Use of systemic antibiotics prophylaxis Pre-Operative | 28 participants |
| Weight | 82.8 kg STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 99 |
| serious Total, serious adverse events | 38 / 99 |
Outcome results
Primary
Functional Outcome: IOWA Ankle Score
The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.
Time frame: Baseline, 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Functional Outcome: IOWA Ankle Score | Score at Baseline, n=52 | 86.3 scores on a scale | Standard Deviation 25.7 |
| ETN PROtect | Functional Outcome: IOWA Ankle Score | Score at 3 months, n=77 | 62.9 scores on a scale | Standard Deviation 20.1 |
| ETN PROtect | Functional Outcome: IOWA Ankle Score | Score at 6 months, n=84 | 76.4 scores on a scale | Standard Deviation 19.6 |
| ETN PROtect | Functional Outcome: IOWA Ankle Score | Score at 12 months, n=77 | 81.2 scores on a scale | Standard Deviation 20.3 |
| ETN PROtect | Functional Outcome: IOWA Ankle Score | Score at 18 months, n=73 | 85.2 scores on a scale | Standard Deviation 18.6 |
Primary
Functional Outcome: WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations.
Time frame: 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Functional Outcome: WOMAC | Score at 3 months, n=80 | 29.3 scores on a scale | Standard Deviation 18.5 |
| ETN PROtect | Functional Outcome: WOMAC | Score at 6 months, n=84 | 24.6 scores on a scale | Standard Deviation 19.1 |
| ETN PROtect | Functional Outcome: WOMAC | Score at 12 months, n=76 | 19.2 scores on a scale | Standard Deviation 19.5 |
| ETN PROtect | Functional Outcome: WOMAC | Score at 18 months, n=73 | 18.2 scores on a scale | Standard Deviation 20 |
Primary
Infection Adverse Events
Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into: * superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue * deep incisional SSI, affecting deep soft tissue * organ/ space SSI (Osteomyelitis), affecting joint or bursa
Time frame: 0 - 18 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN PROtect | Infection Adverse Events | superficial incisional SSI at site of ETN PROtect | 6 number of events |
| ETN PROtect | Infection Adverse Events | deep incisional SSI at site of ETN PROtect | 5 number of events |
| ETN PROtect | Infection Adverse Events | organ/ space SSI at site of ETN PROtect | 0 number of events |
Primary
Quality of Life: EQ-5D
The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
Time frame: 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Quality of Life: EQ-5D | Score at 3 months, n=78 | 0.7 scores on a scale | Standard Deviation 0.2 |
| ETN PROtect | Quality of Life: EQ-5D | Score at 6 months, n=83 | 0.8 scores on a scale | Standard Deviation 0.2 |
| ETN PROtect | Quality of Life: EQ-5D | Score at 12 months, n=78 | 0.8 scores on a scale | Standard Deviation 0.2 |
| ETN PROtect | Quality of Life: EQ-5D | Score at 18 months, n=72 | 0.9 scores on a scale | Standard Deviation 0.1 |
Primary
Quality of Life: SF-12 Mental Component Summary (MCS)
The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Time frame: 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Quality of Life: SF-12 Mental Component Summary (MCS) | Score at 3 months, n=74 | 52.7 scores on a scale | Standard Deviation 10.8 |
| ETN PROtect | Quality of Life: SF-12 Mental Component Summary (MCS) | Score at 6 months, n=82 | 53.2 scores on a scale | Standard Deviation 10.3 |
| ETN PROtect | Quality of Life: SF-12 Mental Component Summary (MCS) | Score at 12 months, n=74 | 53.3 scores on a scale | Standard Deviation 9.9 |
| ETN PROtect | Quality of Life: SF-12 Mental Component Summary (MCS) | Score at 18 months, n=68 | 53.1 scores on a scale | Standard Deviation 10.2 |
Primary
Quality of Life: SF-12 Physical Component Summary (PCS)
The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Time frame: 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Quality of Life: SF-12 Physical Component Summary (PCS) | Score at 3 months, n=74 | 36.9 scores on a scale | Standard Deviation 10 |
| ETN PROtect | Quality of Life: SF-12 Physical Component Summary (PCS) | Score at 6 months, n=82 | 41.2 scores on a scale | Standard Deviation 9.3 |
| ETN PROtect | Quality of Life: SF-12 Physical Component Summary (PCS) | Score at 12 months, n=74 | 45.6 scores on a scale | Standard Deviation 9.1 |
| ETN PROtect | Quality of Life: SF-12 Physical Component Summary (PCS) | Score at 18 months, n=68 | 44.6 scores on a scale | Standard Deviation 10.7 |
Secondary
Evidence of Anatomic Bone Union According to Johnson Classification
Anatomic bone union was assessed according to Johnson et al.\*: A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Time frame: 12 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN PROtect | Evidence of Anatomic Bone Union According to Johnson Classification | A0 | 4 participants |
| ETN PROtect | Evidence of Anatomic Bone Union According to Johnson Classification | A1 | 2 participants |
| ETN PROtect | Evidence of Anatomic Bone Union According to Johnson Classification | A2 | 9 participants |
| ETN PROtect | Evidence of Anatomic Bone Union According to Johnson Classification | A3 | 11 participants |
| ETN PROtect | Evidence of Anatomic Bone Union According to Johnson Classification | A4 | 52 participants |
Secondary
Evidence of Economic Bone Union According to Johnson Classification
Economic bone union was assessed according to Johnson et al.\*: E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Time frame: 12 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN PROtect | Evidence of Economic Bone Union According to Johnson Classification | E0 | 3 participants |
| ETN PROtect | Evidence of Economic Bone Union According to Johnson Classification | E1 | 19 participants |
| ETN PROtect | Evidence of Economic Bone Union According to Johnson Classification | E2 | 8 participants |
| ETN PROtect | Evidence of Economic Bone Union According to Johnson Classification | E3 | 8 participants |
| ETN PROtect | Evidence of Economic Bone Union According to Johnson Classification | E4 | 40 participants |
Secondary
Evidence of Functional Bone Union According to Johnson Classification
Functional bone union was assessed according to Johnson et al.\*: F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity. \*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Time frame: 12 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ETN PROtect | Evidence of Functional Bone Union According to Johnson Classification | F0 | 4 participants |
| ETN PROtect | Evidence of Functional Bone Union According to Johnson Classification | F1 | 1 participants |
| ETN PROtect | Evidence of Functional Bone Union According to Johnson Classification | F2 | 24 participants |
| ETN PROtect | Evidence of Functional Bone Union According to Johnson Classification | F3 | 17 participants |
| ETN PROtect | Evidence of Functional Bone Union According to Johnson Classification | F4 | 32 participants |
Secondary
Likelihood to Develop a Non-union Assessed by Surgeon
The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).
Time frame: 6 weeks, 3 and 6 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Likelihood to Develop a Non-union Assessed by Surgeon | Score at 6 weeks, n=84 | 26.4 scores on a scale | Standard Deviation 19.1 |
| ETN PROtect | Likelihood to Develop a Non-union Assessed by Surgeon | Score at 3 months, n=82 | 23.0 scores on a scale | Standard Deviation 17.7 |
| ETN PROtect | Likelihood to Develop a Non-union Assessed by Surgeon | Score at 6 months, n=84 | 19.6 scores on a scale | Standard Deviation 21.5 |
Secondary
Likelihood to Develop Wound Infection Assessed by Surgeon
The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).
Time frame: 6 weeks, 3 and 6 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Likelihood to Develop Wound Infection Assessed by Surgeon | Score at 6 weeks, n=84 | 19.6 scores on a scale | Standard Deviation 19.6 |
| ETN PROtect | Likelihood to Develop Wound Infection Assessed by Surgeon | Score at 3 months, n=82 | 14.6 scores on a scale | Standard Deviation 13.1 |
| ETN PROtect | Likelihood to Develop Wound Infection Assessed by Surgeon | Score at 6 months, n=84 | 14.4 scores on a scale | Standard Deviation 19.1 |
Secondary
Pain by Visual Analog Scale (VAS)
Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.
Time frame: 6 weeks, 3, 6, 12 and 18 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Pain by Visual Analog Scale (VAS) | Score at 6 weeks, n=82 | 19.3 scores on a scale | Standard Deviation 17.4 |
| ETN PROtect | Pain by Visual Analog Scale (VAS) | Score at 3 months, n=81 | 24.3 scores on a scale | Standard Deviation 16.2 |
| ETN PROtect | Pain by Visual Analog Scale (VAS) | Score at 6 months, n=84 | 27.0 scores on a scale | Standard Deviation 21.2 |
| ETN PROtect | Pain by Visual Analog Scale (VAS) | Score at 12 months, n=78 | 21.0 scores on a scale | Standard Deviation 16.3 |
| ETN PROtect | Pain by Visual Analog Scale (VAS) | Score at 18 months, n=73 | 23.0 scores on a scale | Standard Deviation 19.3 |
Secondary
Patient's Perceived Satisfaction
Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.
Time frame: 6 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~Patient satisfaction was completed by 84 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETN PROtect | Patient's Perceived Satisfaction | 63.8 scores on a scale | Standard Deviation 26.7 |
Secondary
Surgeon's Perceived Satisfaction
Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).
Time frame: 6 weeks, 3 and 6 months post-operatively
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETN PROtect | Surgeon's Perceived Satisfaction | Score at 6 months, n=84 | 14.9 scores on a scale | Standard Deviation 16.7 |
| ETN PROtect | Surgeon's Perceived Satisfaction | Score at 6 weeks, n=84 | 18.2 scores on a scale | Standard Deviation 15.9 |
| ETN PROtect | Surgeon's Perceived Satisfaction | Score at 3 months, n=82 | 18.9 scores on a scale | Standard Deviation 16.8 |
Secondary
Time to Full Weight Bearing
The time from surgery to full weight bearing was assessed in days.
Time frame: 0 - 18 months
Population: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ETN PROtect | Time to Full Weight Bearing | 90.0 days |