Joint Disease
Conditions
Keywords
Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity
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
DEVICEPROCOTYL® C
Hip Arthroplasty
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
To be included in the study, subjects must meet all of the following criteria: * Has previously 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; * Inflammatory degenerative joint disease such as rheumatoid arthritis; * Correction of functional deformity * Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components * Subject is willing and able to complete required study visits or assessments Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided: 1. the specified combination of components 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 THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Survivorship | 10 years post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up; | 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. | 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'. |
| To characterize functional scores, as assessed by EQ-5D-3L scores. | 2-5 years, 5-7 years, and 10 years | 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. |
Countries
Germany
Outcome results
None listed