Active, not recruiting
Observational
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Condition(s) studied
Joint Disease
Investigational drug(s) / intervention(s)
Total Knee Arthroplasty (EVOLUTION®)
Study summary
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Eligibility
Inclusion Criteria:
To be included in the study, subjects must meet all of the following criteria:
* Has previously undergone primary TKA for any of the following:
* non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
* inflammatory degenerative joint disease including rheumatoid arthritis
* correction of functional deformity.
* Subject was implanted with the specified combination of components
* Subject is willing and able to complete required study visits and assessments
* Subject plans to be available through the 10 year postoperative follow-up visit
* Subject is willing to sign the approved Informed Consent document
* Subject must be at least 2 years post TKA prior to informed consent.
Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
* Subject was skeletally immature (less than 21 years of age) at time of implantation
* Subject is currently enrolled in another clinical investigation
* Subject is unwilling or unable to sign the Informed Consent document
* Subject has documented substance abuse issues
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject has a body mass index (BMI) of greater than 40
* Subject is currently incarcerated or has impending incarceration
Primary outcome measure(s)
- Component Survivorship — 10 years post-operative
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
Trial sites (5)
| Facility | City | Region | Status |
| Illinois Bone & Joint Institute |
Morton Grove |
Illinois |
|
| AZ Maria-Middelares |
Ghent |
Belgium |
|
| The Ottawa Hospital |
Ottawa |
Ontario |
|
| Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr |
Mülheim |
Germany |
|
| University Hospital Llandough |
Penarth |
South Glamorgan |
|
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