PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded 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 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 Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Conditions
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Joint Disease

Intervention / Treatment
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* Device: PROFEMUR® Gladiator Plasma Femoral Stems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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 the subject agrees to a second Informed Consent document specific to the second THA. Exclusion Criteria: Subjects implanted with a metal-on-metal articulation Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA 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 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® Gladiator Plasma Femoral Stems<br>Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads. | Device: PROFEMUR® Gladiator Plasma Femoral Stems<br>* THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components<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 analysis 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 Oxford Hip Scores | 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit | 
| Patient functional outcomes (quality of life) | To characterize total functional scores, as assessed by EQ-5D-3L scores | 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit | 

 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