Correction of Functional Deformity, Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options. A single-center, cohort observational clinical outcomes study
Detailed description
Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners Objectives: Primary Objectives: Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device. Secondary Objectives: Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program * Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form * Age: =\> 18 years * Male and Female * Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis & post traumatic arthritis * Rheumatoid arthritis, * Correction of functional deformity * Revision of failed joint reconstruction or treatment * Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques
Exclusion criteria
* Infection, sepsis, and osteomyelitis * Patients who are unwilling or unable to give consent, or to comply with the follow-up program * The patient is known to be pregnant or breastfeeding * Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate) * Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction * Osteoporosis * Metabolic disorder which may impair bone formation * Osteomalacia * Local and distant foci of infection * Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram * Vascular insufficiency, muscular atrophy, or neuromuscular disease * Skeletal immaturity * Morbid obesity * Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation * Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 10 years | Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: \< 70. |
| Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score | 10 years | Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here. |
| 10 Year Survivorship | 10 years post-operative | Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip Score | 10 years | The Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A MoP Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly) | 220 |
| Group B CoC Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic) | 457 |
| Total | 677 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Death | 35 | 25 |
| Overall Study | Device removed | 2 | 10 |
| Overall Study | Lost to Follow-up | 123 | 265 |
| Overall Study | Screen Failure/Not treated | 12 | 8 |
| Overall Study | Withdrawal by Subject | 9 | 8 |
Baseline characteristics
| Characteristic | Group B CoC | Total | Group A MoP |
|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 9.3 | 65.8 years STANDARD_DEVIATION 10.7 | 75.6 years STANDARD_DEVIATION 5.6 |
| Diagnosis Osteoarthritis | 411 Participants | 620 Participants | 209 Participants |
| Diagnosis Other | 46 Participants | 57 Participants | 11 Participants |
| Operative Side Left | 219 Participants | 312 Participants | 93 Participants |
| Operative Side Right | 238 Participants | 365 Participants | 127 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 457 Participants | 677 Participants | 220 Participants |
| Sex: Female, Male Female | 284 Participants | 409 Participants | 125 Participants |
| Sex: Female, Male Male | 173 Participants | 268 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 36 / 208 | 25 / 449 |
| other Total, other adverse events | 1 / 208 | 2 / 449 |
| serious Total, serious adverse events | 63 / 208 | 89 / 449 |
Outcome results
Primary
10 Year Survivorship
Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative.
Time frame: 10 years post-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A MoP | 10 Year Survivorship | 90.47 percentage of participants |
| Group B CoC | 10 Year Survivorship | 97.32 percentage of participants |
Primary
Harris Hip Score
Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: \< 70.
Time frame: 10 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A MoP | Harris Hip Score | 89.8 score on a scale | Standard Deviation 11.2 |
| Group B CoC | Harris Hip Score | 90.4 score on a scale | Standard Deviation 13.2 |
Primary
Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score
Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here.
Time frame: 10 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A MoP | Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score | 6.1 score on a scale | Standard Deviation 2.5 |
| Group B CoC | Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score | 6.8 score on a scale | Standard Deviation 3.5 |
Secondary
Oxford Hip Score
The Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score).
Time frame: 10 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A MoP | Oxford Hip Score | 16.4 score on a scale | Standard Deviation 5.7 |
| Group B CoC | Oxford Hip Score | 18.2 score on a scale | Standard Deviation 9.2 |