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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.
The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.
The secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur with the EVOLUTION® MP CS Tibial Insert | Device | Primary knee arthroplasty or a revision knee that requires a revision procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 10 years |
| 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 | up to 10 years |
| 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 | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Scores | To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS Scores) out to 10 years follow-up. | Year 1,Year 3, Year 5, Year 7, and Year 10 |
| Functional Scores |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JoAnna-Marie N Becker, BS | Contact | +1 901 290 5280 | joannamarie.becker@ortho.microport.com | |
| Pietro Randelli, Prof | Contact | +39-335-5292-622 | pietro.randelli@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Pietro I Randelli, Prof | Gaetano Pini Orthopedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaetano Pini Orthopedic Institute | Recruiting | Milan | Piazza C. Ferrari 1 20122 Milan | Italy |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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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.
| Year 1,Year 3, Year 5, Year 7, and Year 10 |
| Functional Scores | To assess functional scores utilizing EQ-5D-5L at specified intervals out to 10 years follow-up. | Year 1,Year 3, Year 5, Year 7, and Year 10 |
| Subject Satisfaction | To assess subject satisfaction with their TKA procedure via the Satisfaction Survey at specified intervals out to 10 years follow-up. | Year 1,Year 3, Year 5, Year 7, and Year 10 |
| Radiolucencies | To assess the presence of radiolucencies surrounding the implanted components at specified intervals out to 10 years follow-up. | Year 1,Year 3, Year 5, Year 7, and Year 10 |
| To assess subject safety: Adverse Events o Adverse Events related to study device or the index surgical procedure | To assess safety and characterize protocol defined adverse events and adverse device effects. | Year 1,Year 3, Year 5, Year 7, and Year 10 |
| Incidence of component revision | Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up. | Year 1,Year 3, Year 5, Year 7, and Year 10 |