Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

Running, not enrolling

Conditions studied: Joint Disease

In brief

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.

Key facts

Study ID

NCT02351414

Run by

MicroPort Orthopedics Inc.

People needed

150

Starts

2015-06-15

Expected to finish

2028-12-01

Last updated by the study team

2022-10-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Illinois Bone & Joint Institute — Morton Grove, Illinois, United States
• AZ Maria-Middelares — Ghent, Belgium
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr — Mülheim, Germany
• University Hospital Llandough — Penarth, South Glamorgan, United Kingdom

Full record on ClinicalTrials.gov

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