Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

Study Overview
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Brief Summary
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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.

Official Title
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Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

Conditions
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Joint Disease

Intervention / Treatment
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* Device: PROCOTYL® C


Participation Criteria
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Eligibility Criteria
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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: the specified combination of components were implanted in both, all other aspects of the Inclusion/Exclusion Criteria are satisfied, enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 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. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: Subject was skeletally immature (less than 21 years of age) at time of implantation Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol Subject is unwilling or unable to sign the Informed Consent document Subject has documented substance abuse issues Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject is currently incarcerated or has impending incarceration

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Total Hip Arthroplasty<br>Single arm study of subjects previously implanted with any MicroPort Orthopedics or Wright Medical Technology femoral stems and PROCOTYL® C Acetabular Components | Device: PROCOTYL® C<br>* Hip Arthroplasty<br>* Other names: Primary Total Hip Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity