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Sponsor decision to not renew CE mark on product. Therefore study not needed.
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MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROFEMUR® Am Femoral Stem | Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell | Device | PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional outcomes (hip specific) | To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores | Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval |
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Inclusion Criteria:
Subject has undergone primary THA for any of the following:
Exclusion Criteria:
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Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component
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| Name | Affiliation | Role |
|---|---|---|
| Gérard Giordano, MD | Hopital Joseph Ducuing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Joseph Ducuing | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
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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 |