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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, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroplasty) components including acetabular shells, acetabular liners and femoral heads. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROFEMUR® Preserve Femoral Stem | Device | Total Hip Total Hip Arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up. | Percentage of hips survived with no revision or replacement at 10-year. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck 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. | Time Frame: 2-5 years, 5-7 years, and 10 years |
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Newly or previously implanted subjects must meet all the following inclusion Criteria:
Newly or previously implanted bilateral subjects can have both Total Hip Arthroscopy enrolled in the study provided: 1) the specified PROFEMUR® Preserve Femoral Stems and cobalt-chromium Modular Necks were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second Total Hip Arthroscopy.
Previously implanted subjects who had undergone revision of any Total Hip Arthroscopy component including the PROFEMUR® Preserve Femoral Stem(s) or, cobalt-chromium Modular Neck will also be eligible to be considered for this study.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroscopy) components including acetabular shells, acetabular liners and femoral heads.
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| Name | Affiliation | Role |
|---|---|---|
| Manel Ribas, MD | Hospital Universitari Dexeus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Manel Ribas | Barcelona | 08028 | Spain |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores. | 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'. 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. | Time Frame: 2-5 years, 5-7 years, and 10 years |
| To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components. | Radiolucencies are described around 7 zones and we will be reporting the number of hips with radiolucencies present at a given zone. | 2-5 years, 5-7 years, and 10 years |
| To characterize of adverse events and adverse device effects. | Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effect (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will be also provided. | 2-5 years, 5-7 years, and 10 years |