NCT04145401Enrolling by invitation
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert
Source: ClinicalTrials.gov · Last updated 20 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 45 (estimated)
- First submitted
- 17 Oct 2019
- Start date
- 30 Sept 2020
- Primary completion date
- 1 May 2033
- Lead sponsor
- MicroPort Orthopedics Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04145401
What you commit to
- Study type: Observational
- Planned participants: 45
- From 30 Sept 2020 to the primary completion date, 1 May 2033
- 1 site in 1 country
- 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.
Prior treatment
- Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
Other illness
- Has an overt infection at the time of implantation.
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol.
Age
- Skeletally immature (less than 21 years of age) at time of implantation.
Other
- Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
- Has documented substance abuse issues.
- Currently incarcerated or has impending incarceration.
Who the study is looking for
- Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
- Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
- Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
- Bilateral subjects can have both TKAs enrolled in the study provided:
- the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
- all other aspects of the Inclusion/Exclusion Criteria are satisfied
- enrollment does not exceed the subject count specified
- the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HCA Research Institute, OrthoONE at Swedish Medical Center Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.