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| Name | Class |
|---|---|
| Biomet U.K. Ltd. | INDUSTRY |
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This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.
Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taperloc Microplasty | Experimental | Patients with primary osteoarthritis with Taperloc microplasty non inferiority |
|
| Taperloc Standard | Active Comparator | Patients with primary osteoarthritis Taperloc standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taperloc Microplasty | Device | primary total hip arthroplasty |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: | bone mineral density (BMD) measured postoperatively at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome measures with Harris Hip Score comparing patients receiving different stems. | 3, 6, 12 and 24 months | |
| Clinical outcome measures with Womac Score comparing patients receiving different stems. | 3, 6, 12 and 24 months |
Inclusion criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ingemar IVARSSON, PhD | University hospital of Linkoping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Linkoping | Linköping | 581 85 | Sweden |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Taperloc standard |
| Device |
primary total hip arthroplasty |
|