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MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revision Total Hip Arthroplasty | Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROFEMUR® L Revision Femoral Stem | Device | Revision Total Hip Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who require a revision | The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional score on the the Oxford Hip Score instrument | To characterize patient hip-related health status, as assessed by Oxford Hip Scores | Screening (First Available), 2-5 years, 5-7 years, and 10 years |
| Patient functional score on the EQ-5D-3L instrument |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 22, 2025 | |
| Reset | Feb 14, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 22, 2025 | Feb 14, 2025 |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D000844 | Ankylosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
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To characterize patient general health status, as assessed by EQ-5D-3L scores |
| Screening (First Available), 2-5 years, 5-7 years, and 10 years |
| 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 |