PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated 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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Official Title
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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

Conditions
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Joint Disease

Intervention / Treatment
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* Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has undergone primary THA 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 THA surgery Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA 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 having 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 |
| --- | --- |
| PROFEMUR® Am Femoral Stem<br>Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component | Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell<br>* PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component<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 using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device. | 10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient functional outcomes (hip specific) | To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores | Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, avascular necrosis, correction of functional deformity, painful hip dysplasia, protrusio acetabuli, rheumatoid arthritis, ankylosis