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Business reasons
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The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Rotating Platform Cruciate Retaining Knee implant |
|
| 2 | Active Comparator | Rotating Platform Cruciate Substituting Knee implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Device | Rotating Platform (RP) Cruciate Retaining Knee implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society scores | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | On-going to end of study | |
| Revisions | On-going to end of study | |
| Medical imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy L O'Dell, EMT, CCRA | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
| West Coast Orthopaedic Specialists |
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| Total knee replacement | Device | Rotating Platform (RP) Cruciate Substituting Knee implant. |
|
|
| Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| SF-12 patient outcomes | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| Crystal River |
| Florida |
| 34429 |
| United States |
| Melbourne | Florida | 32901 | United States |
| Cleveland Heights | Ohio | 44118 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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