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
This trial does not accept healthy volunteersQualifiers
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 population
Multicenter, prospective follow-up study of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of the study index surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
DevicePrimary knee arthroplasty or a revision knee that requires a revision procedure.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Revision Total Knee Arthroplasty1 intervention
Trial outcomes
Primary outcomes
1
The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Time frame
up to 10 years2
The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Time frame
up to 10 years3
The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.
Percentage of knees survived with no revision or replacement at 10-year
Time frame
up to 10 yearsSecondary outcomes
1
Functional Scores
To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS Scores) out to 10 years follow-up.
Time frame
Year 1,Year 3, Year 5, Year 7, and Year 102
Functional Scores
To assess subject satisfaction with their Total Knee Arthroplasty (TKA) procedure utilizing the Forgotten Joint Score (FJS) at specified intervals out to 10 years follow-up.
Time frame
Year 1,Year 3, Year 5, Year 7, and Year 103
Functional Scores
To assess functional scores utilizing EQ-5D-5L at specified intervals out to 10 years follow-up.
Time frame
Year 1,Year 3, Year 5, Year 7, and Year 104
Subject Satisfaction
To assess subject satisfaction with their TKA procedure via the Satisfaction Survey at specified intervals out to 10 years follow-up.
Time frame
Year 1,Year 3, Year 5, Year 7, and Year 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov