Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Study Overview
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Brief Summary
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Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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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Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA 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 THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Official Title
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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Conditions
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Joint Disease

Intervention / Treatment
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* Device: total hip arthroplasty implant


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 Exclusion Criteria: Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells Subjects implanted with a metal-on-metal articulation Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) 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 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 |
| --- | --- |
| Total Hip Arthroplasty<br>Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head. | Device: total hip arthroplasty implant<br> <br> * Other names: PROFEMUR® TL modular femoral stem;|

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 component survivorship of all components out to 10 years follow-up. | 10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient functional outcomes | The secondary objective is to characterize total functional scores, as assessed by HOOS scores and EQ-5D-3L scores. | 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