NCT02351414Active, not recruiting
Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Source: ClinicalTrials.gov · Last updated 13 Oct 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 22 Jan 2015
- Start date
- 15 Jun 2015
- Primary completion date
- Jun 2027
- Lead sponsor
- MicroPort Orthopedics Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02351414
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 15 Jun 2015 to the primary completion date, Jun 2027
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Age
- Subject was skeletally immature (less than 21 years of age) at time of implantation
Other
- Subjects will be excluded if they meet any of the following criteria:
- 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 a body mass index (BMI) of greater than 40
- Subject is currently incarcerated or has impending incarceration
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr Coordinator of this site? Confirm its status | Mülheim | Germany | Unknown status |
| University Hospital Llandough Coordinator of this site? Confirm its status | Penarth | United Kingdom | Unknown status |
| Illinois Bone & Joint Institute Coordinator of this site? Confirm its status | Morton Grove | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.