Joint Disease
Conditions
Keywords
Osteoarthritis, Ankylosis, Revision procedures, Correction of functional deformity, Rheumatoid arthritis, Arthritis
Brief 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.
Detailed description
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
Interventions
DEVICETotal Knee Arthroplasty (EVOLUTION®)
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores) | 2-<5 years, 5-7 years, and 10 years | To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores |
| Cumulative Revision Rate | 2-<5 years, 5-7 years, and 10 years | To determine the cumulative revision rate at specified intervals out to 10 years follow-up |
| Subject Satisfaction (assessed by Patient Satisfaction Questionnaires) | 2-<5 years, 5-7 years, and 10 years | To assess subject satisfaction with their TKA procedure |
| Number of Radiolucencies | 2-<5 years, 5-7 years, and 10 years | To summarize the number of radiolucencies in zones surrounding implanted components |
| Size of Radiolucencies | 2-<5 years, 5-7 years, and 10 years | To summarize the size of radiolucencies in zones surrounding implanted components |
Countries
Belgium, Canada, Germany, United Kingdom, United States
Outcome results
None listed