Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System with Cruciate Sacrificing Inserts (Project AMETHYST)
- Conditions
- M24M25Other specific joint derangementsOther joint disorders, not elsewhere classified
- Registration Number
- DRKS00011069
- Lead Sponsor
- MicroPort Orthopedics Inc.USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 150
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.
Subjects will be excluded if they meet any of the following criteria:
- Subject was skeletally immature (less than 21 years of age) at time of implantation
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject has a body mass index (BMI) of greater than 40
- Subject is currently incarcerated or has impending incarceration
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints are Kaplan-Meier estimates of survivorship for all components at each follow-up interval out to 10 years. This is done by capturing whether a revision is done yes/no, when the patient comes in for a routine follow-up visit (2-5, 5-7 and 10 years post-operatively).
- Secondary Outcome Measures
Name Time Method Characterization of total functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores. These questionnaires are filled out by the patient pre-operatively and 2-5, 5-7, and 10 years post-operatively.<br>Proportion of subjects reporting being satisfied with their TKA and proportion of subjects who would have their procedure performed again as assessed by questionnaire 2-5, 5-7, and 10 years post-operatively.<br>A summary of the number and size of radiolucencies in zones surrounding implanted components as assessed by evaluating radiographs taken 2-5, 5-7, and 10 years post-operatively.