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Not feasible - RSA machine not available. RSA images needed for study endpoints
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MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROFEMUR Preserve RSA | Other | Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROFEMUR Preserve Classic Femoral Components | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance. | Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup. | 24 months |
| Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA | Assessment of migration in each individual plane (x, y, and z), as measured in mm. | 24 months |
| Assess if migration pattern is greater than 0.2mm between 1 and 2 years | To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional outcomes (HOOS) | The secondary objective is to determine if there is a significant difference in health status and functional outcomes (using the HOOS questionnaire) before and after total hip arthroplasty (THA) using the PROFEMUR® Preserve Femoral Components. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Maisonneuve Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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