AMETHYST: Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
Study Details
Study Description
Brief Summary
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Total Knee Arthroplasty Single study group previously implanted with the EVOLUTION® TKA System with cruciate sacrificing (CS) inserts |
Device: Total Knee Arthroplasty (EVOLUTION®)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Component Survivorship [10 years post-operative]
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
Secondary Outcome Measures
- Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores) [2-<5 years, 5-7 years, and 10 years]
To characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-3L Scores
- Cumulative Revision Rate [2-<5 years, 5-7 years, and 10 years]
To determine the cumulative revision rate at specified intervals out to 10 years follow-up
- Subject Satisfaction (assessed by Patient Satisfaction Questionnaires) [2-<5 years, 5-7 years, and 10 years]
To assess subject satisfaction with their TKA procedure
- Number of Radiolucencies [2-<5 years, 5-7 years, and 10 years]
To summarize the number of radiolucencies in zones surrounding implanted components
- Size of Radiolucencies [2-<5 years, 5-7 years, and 10 years]
To summarize the size of radiolucencies in zones surrounding implanted components
Eligibility Criteria
Criteria
Inclusion Criteria:
To be included in the study, subjects must meet all of the following criteria:
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Has previously undergone primary TKA for any of the following:
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non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
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inflammatory degenerative joint disease including rheumatoid arthritis
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correction of functional deformity.
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Subject was implanted with the specified combination of components
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Subject is willing and able to complete required study visits and assessments
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Subject plans to be available through the 10 year postoperative follow-up visit
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Subject is willing to sign the approved Informed Consent document
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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:
- 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.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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Subject was skeletally immature (less than 21 years of age) at time of implantation
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Subject is currently enrolled in another clinical investigation
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Subject is unwilling or unable to sign the Informed Consent document
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Subject has documented substance abuse issues
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Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
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Subject has a body mass index (BMI) of greater than 40
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Subject is currently incarcerated or has impending incarceration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Illinois Bone & Joint Institute | Morton Grove | Illinois | United States | 60053 |
| 2 | AZ Maria-Middelares | Gent | Belgium | ||
| 3 | The Ottawa Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
| 4 | Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr | Mülheim | Germany | D-45468 | |
| 5 | University Hospital Llandough | Penarth | South Glamorgan | United Kingdom | CF64 2XX |
Sponsors and Collaborators
- MicroPort Orthopedics Inc.
Investigators
- Principal Investigator: Marcus Jäger, Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
- Principal Investigator: Philippe Van Overschelde, MD, Algemeen Ziekenhuis Maria Middelares
- Principal Investigator: Rhys Llewellyn Williams, MD, University Hospital Llandough
- Principal Investigator: Ritesh Shah, MD, Illinois Bone and Joint Institute
- Principal Investigator: Geoffrey Dervin, MD, Ottawa Hospital, General Campus, CCW 1646
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13-LJK-001