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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 Europe. 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 |
|---|---|---|---|
| Primary Total Hip Arthroplasty | Single arm study of subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology femoral stems and PROCOTYL® C Acetabular Components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROCOTYL® C | Device | Hip Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up; | Percentage of hips that were revised or replaced at each of the intervals namely for Early (2-5 years), midterm (5-7 Year), and long-term (10-year) evaluation. | 2-5 years, 5-7 years, and 10 years |
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Inclusion Criteria:
To be included in the study, subjects must meet all of the following criteria:
Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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Subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology Femoral Stems and PROCOTYL® C Acetabular Components
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elbe Kliniken Buxtehude | Buxtehude | 21614 | Germany |
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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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| To characterize functional scores, as assessed by Oxford Hip. |
The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'. |
| 2-5 years, 5-7 years, and 10 years |
| To characterize functional scores, as assessed by EQ-5D-3L scores. | EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems. | 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 |