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| ID | Type | Description | Link |
|---|---|---|---|
| #G120038 | Other Identifier | IDE approved by CDRH |
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To demonstrate the safety and effectiveness of the Trinityâ„¢ BIOLOX deltaâ„¢ Ceramic-on-Ceramic Total Hip System in comparison to the Trinityâ„¢ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.
The clinical research results for the Trinityâ„¢ BIOLOX deltaâ„¢ Ceramic-on-Ceramic Total Hip System will be compared to the control device
Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trinity CoC Total Hip System | Experimental | total hip replacement with a ceramic femoral head and ceramic acetabular cup liner |
|
| Trinity Ceramic-on-Poly THR | Active Comparator | total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trinity CoC Total Hip System | Device | total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical Success |
| 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| HHS | • Individual components of the Harris Hip Score (total score, pain and function). | 24 months post-operative |
| HOOS score | Hip injury and Osteoarthritis Outcome Score (HOOS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Trier, Ph.D. | Corin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Specialty Orthopaedics | Little Rock | Arkansas | 72205 | United States | ||
| Denver Hip and Knee, Inc. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Trinity Ceramic-on-Poly THR | Device | total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner |
|
| 24 months |
| Subjective pain | VAS pain score | 24 months |
| survival | Kaplan-Meier survival curve | 24 months |
| adverse events | Summary of device-related complications | 24 months |
| Parker |
| Colorado |
| 80134 |
| United States |
| Connecticut Joint Replacement Institute (CJRI) | Hartford | Connecticut | 06105 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Florida Orthopaedic Institute | Tampa | Florida | 33609 | United States |
| FMC Orthopedic Division | Tampa | Florida | 33613 | United States |
| Resurgens Orthopaedics | Austell | Georgia | 30106 | United States |
| OrthoCarolina Hip & Knee Center | Charlotte | North Carolina | 28207 | United States |
| Memorial Bone & Joint | Houston | Texas | 77043 | United States |
| Elective Orthopaedic Centre | Epsom | Surrey | KT18 7EG | United Kingdom |
| 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 |