Post Market Clinical Follow-Up Study- EVOLUTIONĀ® Revision CCK
United States45 participantsStarted 2020-09-30
Plain-language summary
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTIONĀ® Revision CCK Tibia and EVOLUTIONĀ® Revision CCK Femur with EVOLUTIONĀ® 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTIONĀ® Revision Tibial System and EVOLUTIONĀ® Revision CCK Femur with the EVOLUTIONĀ® CCK Tibial Insert)
ā. Decision to perform the study index surgery with the required study components (EVOLUTIONĀ® Revision Tibial System and EVOLUTIONĀ® Revision CCK Femur with the EVOLUTIONĀ® CCK Tibial Insert) is pre-determined regardless of the research.
ā. Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
ā. Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
ā. the specified combination of components (EVOLUTIONĀ® Revision Tibial System and EVOLUTIONĀ® Revision CCK Femur with the EVOLUTIONĀ® CCK Tibial Insert) were implanted in both
Exclusion criteria
ā. enrollment does not exceed the subject count specified
ā. the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
. Skeletally immature (less than 21 years of age) at time of implantation.
ā. Has an overt infection at the time of implantation.
ā. 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.
ā. Currently enrolled in another clinical investigation which would affect the endpoints of this protocol.
ā. Has documented substance abuse issues.
ā. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.