Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
The objectives of this study are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revision Knee implants | Device | Primary knee arthroplasty or a revision knee that requires a revision procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Individual component survivorship | Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes- Questionnaires |
|
Not provided
Inclusion Criteria:
Bilateral subjects can have both TKAs enrolled in the study provided:
Exclusion Criteria:
Not provided
Not provided
Not provided
Primary TKA or Revision
Single study group with either newly or previously implanted patients with EVOLUTION® Revision Tibia and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Insert.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCA Research Institute, OrthoONE at Swedish Medical Center | Englewood | Colorado | 80113 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 28, 2025 | |
| Reset | Nov 10, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 28, 2025 | Nov 10, 2025 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 years post-operative |
| Incidence of component revision | the cumulative incidence of component revision at specified intervals will be determined out to 10 years follow-up | 10 years post-operative |
| Radiolucencies | the presence, zone, and the size of radiolucencies surrounding implanted components will be determined | 10 years post-operative |
| Adverse Events and Adverse Device Effects | characterization of adverse events and adverse device effects | 10 years post-operative |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |