Ireland
--:--IST
Active, not recruiting Observational

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

NCT02351414 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2015-06-15
Last updated
2022-10-13

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

Sex
ALL
Min age
21 Years
Max age
—
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. 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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02351414 on ClinicalTrials.gov ↗ ← All trials in the USA