EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
ConditionJoint Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorMicroPort Orthopedics Inc.
About this trial
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Eligibility criteria
Qualifiers
Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
Willing to voluntarily sign the informed consent form
Disqualifiers
Skeletally immature (less than 21 years of age) at time of implantation
Has or had an overt infection at the time of implantation
Has or had 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
Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Trial design
Treatments tested in this trial
- EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov