Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
Study Details
Study Description
Brief Summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The objectives of this study are:
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To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
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To find out the cumulative incidence of component revision of each component in this combination.
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To find out the functional outcome scores at early, midterm, and long term follow-up.
Study Design
Outcome Measures
Primary Outcome Measures
- Individual component survivorship [10 years post-operative]
Individual component survivorship for tibial base, femoral, and tibial CS insert at specified intervals out to 10 years follow-up.
Secondary Outcome Measures
- Patient Reported Outcomes- Knee Injury and Osteoarthritis Outcome Scores [10 years post-operative]
-functional scores for subjects, as assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS), out to 10 years follow-up
- Patient Reported Outcomes- EuroQol-5D-5L Scores [10 years post-operative]
-functional scores for subjects, as assessed by EuroQol-5D-5L (EQ-5D-5L) Scores, out to 10 years follow-up
- Patient Reported Outcomes- Forgotten Joint Score [10 years post-operative]
-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Forgotten Joint Score
- Patient Reported Outcomes- Satisfaction Survey [10 years post-operative]
-subject satisfaction measures with their Total Knee Arthroplasty (TKA) procedure using the Satisfaction Survey
- Incidence of component revision [10 years post-operative]
the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up
- Radiolucencies [10 years post-operative]
the presence, zone, and the size of radiolucencies surrounding implanted components will be determined
- Adverse Events and Adverse Device Effects [10 years post-operative]
characterization of adverse events and adverse device effects
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
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Has previously undergone or currently has determined to undergo a 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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willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
- Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation
Exclusion Criteria:
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Skeletally immature (less than 21 years of age) at time of implantation
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Has or had an overt infection at the time of implantation
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Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
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Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
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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
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Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
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Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
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Unwilling or unable to sign the Informed Consent document
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Has documented substance abuse issues
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Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
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Currently incarcerated or has impending incarceration
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Covenant Medical Center | Saginaw | Michigan | United States | 48602 |
Sponsors and Collaborators
- MicroPort Orthopedics Inc.
Investigators
- Principal Investigator: Brian de Beaubien, MD, Covenant Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17K001