Joint Disease
Conditions
Brief summary
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.
Interventions
DEVICEPROFEMUR® Preserve Femoral Stem
Total Hip Total Hip Arthroscopy
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly or previously implanted subjects must meet all the following inclusion Criteria: * Has undergone primary Total Hip Arthroscopy for any of the following: * Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;lnflammatory degenerative joint disease such as rheumatoid arthritis; or * Correction of functional deformity; * Subject is implanted with the PROFEMUR® Preserve Femoral Stem(s) and cobalt-chromium Modular Neck; * Subject is willing and able to complete required study visits or assessments through the 10 year postoperative follow-up schedule; * Subject is implanted with WMT or MPO head, cup and liner. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up. | 10 years | Percentage of hips survived with no revision or replacement at 10-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time Frame: 2-5 years, 5-7 years, and 10 years | 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. |
| To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores. | Time Frame: 2-5 years, 5-7 years, and 10 years | 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. |
| To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components. | 2-5 years, 5-7 years, and 10 years | Radiolucencies are described around 7 zones and we will be reporting the number of hips with radiolucencies present at a given zone. |
| To characterize of adverse events and adverse device effects. | 2-5 years, 5-7 years, and 10 years | 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. |
Countries
Spain
Outcome results
None listed