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Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:
Primary endpoint:
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.
Secondary endpoints:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Uncemented Total Hip Arthroplasty | Device | The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem |
| Measure | Description | Time Frame |
|---|---|---|
| Composite success of cup inclination and cup version. | The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks:
| 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inclination success | Inclination Success: within 10 degrees of the planned inclination | 6 weeks |
| Version success | Version success: within 10 degrees of the planned version |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who the investigator deems to be a candidate for a primary total hip arthroplasty (THA) using the study devices (Pinnacle cup with a Corail or Summit stem) in a primary uncemented THA.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Michigan | Grand Rapids | Michigan | 49503 | United States | ||
| Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39061099 | Derived | Fawley D, Bernard T, Thomason HC 3rd, Zagra L, Ten Broeke RHM, Johnson K. Early functional recovery outcomes and return to work after primary total hip arthroplasty: a novel patient reported outcomes questionnaire. J Orthop Surg Res. 2024 Jul 26;19(1):434. doi: 10.1186/s13018-024-04937-z. | |
| 38727945 | Derived |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 6 weeks |
| 90 day postoperative complication rates | The number of subjects and the percentage of subjects with complications at 90 days post-operatively | 90 days postoperative |
| Harris Hip Score | Change from preoperative baseline for the Harris Hip Score | Baseline and 6 and 12 weeks postoperative |
| Forgotten Joint Score | Change from 6 week baseline for the Forgotten Joint Score | 6 and 12 weeks postoperative |
| EQ-5D-5L dimension score | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative |
| EQ-VAS score (subscore of EQ-5D-5L) | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative |
| EQ-5D-5L index value (if applicable) | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative |
| Radiographic Outcomes | Radiographs will be read by an independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be compared to radiographs taken at later time points (12 weeks). Parameters measured include subsidence, migration, inclination and version angles, osteolysis, and radiolucency. | Baseline and 6 and 12 weeks postoperative |
| New York |
| New York |
| 10029 |
| United States |
| Carolina Orthopaedic and Sports Medicine Center | Gastonia | North Carolina | 28054 | United States |
| Orthopedic Specialists and Sports Medicine | Newark | Ohio | 43055 | United States |
| Lowcountry Orthopaedics & Sports Medicine | Charleston | South Carolina | 29406 | United States |
| Istituto Orthopedico Galeazzi IRCCS | Milan | Italy |
| Bravis Hospital | Bergen op Zoom | Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Canisius Wilhelmina Hospital | Nijmegen | Netherlands |
| Woodend Hospital | Aberdeen | Scotland | United Kingdom |
| Glan Clwyd Hospital | Rhyl | Wales | United Kingdom |
| Meermans G, Fawley D, Zagra L, Ten Broeke RHM, Johnson K, Bernard T, Thomason HC 3rd. Accuracy of cup placement compared with preoperative surgeon targets in primary total hip arthroplasty using standard instrumentation and techniques: a global, multicenter study. J Orthop Traumatol. 2024 May 10;25(1):25. doi: 10.1186/s10195-024-00766-2. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |