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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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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® Gladiator Plasma Femoral Stems | Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROFEMUR® Gladiator Plasma Femoral Stems | Device | THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient functional outcomes (hip specific) | To characterize total functional scores, as assessed by Oxford Hip Scores | 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit |
| Patient functional outcomes (quality of life) |
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Inclusion Criteria:
Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
Exclusion Criteria:
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Patients who have been previously implanted with a PROFEMUR® Gladiator Plasma Femoral Stem and PROCOTYL® L Beaded Acetabular Component
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| Name | Affiliation | Role |
|---|---|---|
| Jose Pimienta | Elbe Kliniken Buxtehude | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elbe Kliniken Buxtehude | Buxtehude | 21614 | Germany |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2024 | |
| Reset | Aug 15, 2024 | |
| Release | Nov 27, 2024 | |
| Reset | Jan 13, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2024 | Aug 15, 2024 | |||
| Nov 27, 2024 |
| 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 total functional scores, as assessed by EQ-5D-3L scores |
| 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit |
| Jan 13, 2025 |
| 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 |