Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Study Overview
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Brief Summary
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MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Detailed Description
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MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Official Title
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Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

Conditions
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Joint Disease

Intervention / Treatment
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* Device: Primary hip resurfacing device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has undergone primary hip resurfacing 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; or Correction of functional deformity Subject is implanted with the specified combination of components Subject is willing and able to complete required study visits or assessments Exclusion Criteria: Subjects skeletally immature (less than 21 years of age) at time of primary resurfacing surgery Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol Subjects unwilling to sign the Informed Consent document Subjects with substance abuse issues Subjects who are incarcerated or have pending 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 Hip Resurfacings<br>Single study group previously implanted with CONSERVE® Press-Fit Femoral Components | Device: Primary hip resurfacing device<br>* CONSERVE® Press-Fit Femoral Components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component Survivorship | The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up. | 10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient functional outcomes | To characterize total functional scores, as assessed by HOOS and EQ-5D-3L scores | Screening (First Available), 2-5 years, 5-7 years, and 10 years | 
| Component alignment | To evaluate component alignment (neck shaft angle, stem shaft angle, and cup inclination) and the presence of radiolucencies surrounding implanted components | Screening (First Available), 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, revision procedures