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Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Arthroplasty | Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total hip arthroplasty implant | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional outcomes | The secondary objective is to characterize total functional scores, as assessed by HOOS scores and EQ-5D-3L scores. | Screening (First Available), 2-5 years, 5-7 years, and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been previously implanted with a primary PROFEMUR® TL Modular Femoral Stem
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| Name | Affiliation | Role |
|---|---|---|
| Paul Beaule, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital | Ottawa | Ontario | K1H-8L6 | Canada |
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| 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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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |