Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing 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 components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Hip Resurfacings | Single study group previously implanted with CONSERVE® Press-Fit Femoral Components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary hip resurfacing device | Device | CONSERVE® Press-Fit Femoral Components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional outcomes | To characterize total functional scores, as assessed by HOOS and EQ-5D-3L scores | Screening (First Available), 2-5 years, 5-7 years, and 10 years |
| Component alignment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who have been previously implanted with CONSERVE® Press-Fit Femoral Components
Not provided
| 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 |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate component alignment (neck shaft angle, stem shaft angle, and cup inclination) and the presence of radiolucencies surrounding implanted components
| 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 |