Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

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® Gladiator HA Coated Modular Femoral Stems

Conditions
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Joint Disease

Intervention / Treatment
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* Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem


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 Previously implanted bilateral subjects can have both THAs 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 Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study. Exclusion Criteria: Subjects skeletally immature (less than 21 years of age) at time of primary THA 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

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® Gladiator HA Coated Stem<br>Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite) | Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem<br>* Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem<br>* Other names: Primary hip replacement device;|

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 (hip specific) | To characterize total functional scores, as assessed by Hip disability and Osteoarthritis Outcome Scores (HOOS) | 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval | 
| Patient functional outcomes (quality of life) | To characterize total functional scores, as assessed by EQ-5D-3L scores | 5 months, 1, 2, 5, 7, and 10 years 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, ankylosis, protrusio acetabuli, painful hip dysplasia, rheumatoid arthritis, correction of functional deformity, revision procedures