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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.
Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident II Hemispherical cup (Stryker Orthopaedics) | Active Comparator | Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup |
|
| Trident II Tritanium cup (Stryker Orthopaedics) | Active Comparator | Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty | Device | Total hip arthroplasty with a Trident II hemispherical cup |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival at 3 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant migration measured with Computer Tomography Microanalysis in a subcohort of patients motion Analysis (CTMA) in a sub-cohort of patients | Using Computer Tomography Micro-motion Analysis (CTMA) to measure implant migration in a sub-cohort of patients | CTMA will be done postoperatively, 3 month and 6 months and 2 years after total hip replacement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maziar Mohaddes, MD, PhD | Contact | +46730701147 | maziar.mohaddes@gmail.com | |
| Adam Rosenbaum, MD | Contact | +46705330149 | adamrosenbaum81@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics | Recruiting | Mölndal | Västra Götaland County | S-43180 | Sweden |
Due to regulations associated with national registers in Sweden alla data will be presented on an aggregated level, individual patient data will not be shared.
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total hip arthroplasty | Device | Total hip arthroplasty with a Trident II Tritanium cup |
|
| Implant survival at 10 years | Kaplan Meier survival data, cup revision and risk of revision used as endpoints | 10 years |
| EQ-5D | Patient-reported generic health outcome measure | 10 years |
| Plain radiographs in a sub-cohort of patients | Using plain radiographs to evaluate signs of loosening and implant position | 10 years |
| Adverse events using the national patient register | ICD codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This database includes mainly secondary care visits | 10 years |
| Adverse events using the regional VEGA database | ICD (International Classification of Diseases) codes för surgical and medical adverse events following primary total hip arthroplasty, as defined by the National Board of Health and Welfare will be merged with data in the SHAR (The Swedish Hip Arthroplasty Register). This regional database includes all contacts (both within primary and secondary care) for patients living in the region of Western Sweden | 10 years |
| Oxford Hip Score | Patient-reported hip specific outcome measure | 10 years |
| Forgotten Joint Score | Patient-reported hip specific outcome measure | 10 years |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |