EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
NCT ID: NCT06142669
Last Updated: 2024-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2023-10-31
2036-12-31
Brief Summary
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Detailed Description
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The secondary objectives include:
* Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
* Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
* To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
* To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
* To assess safety and characterize protocol defined adverse events and adverse device effects.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Revision Total Knee Arthroplasty
Single study group with either newly or previously implanted subjects with the EVOLUTION® Revision Tibia and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Insert.
EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Primary knee arthroplasty or a revision knee that requires a revision procedure.
Interventions
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EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert
Primary knee arthroplasty or a revision knee that requires a revision procedure.
Eligibility Criteria
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Inclusion Criteria
2. Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
3. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
4. Willing to voluntarily sign the informed consent form
5. Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Exclusion Criteria
2. Has or had an overt infection at the time of implantation
3. 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
4. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
5. Has or had documented substance abuse issues
6. Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
7. Currently incarcerated or has impending incarceration
8. 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
21 Years
ALL
No
Sponsors
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MicroPort Orthopedics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pietro I Randelli, Prof
Role: PRINCIPAL_INVESTIGATOR
Gaetano Pini Orthopedic Institute
Locations
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Gaetano Pini Orthopedic Institute
Milan, Piazza C. Ferrari 1 20122 Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18K001CS
Identifier Type: -
Identifier Source: org_study_id
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