Long-Term Multi-center Evaluation of E-Poly and Regenerex

Study Overview
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Brief Summary
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There are two distinct aims of this study: This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.

Official Title
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Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

Conditions
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Osteoarthritis of Hip, Traumatic Arthritis of Hip

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects requiring primary total hip replacement Subjects with diagnosis of osteoarthritis or traumatic arthritis Subjects who demonstrate the ability to return for follow-up for the next 10 years Exclusion Criteria: Subjects with limited life span Subjects with difficulty in comprehending study protocol for any reason. Subjects with inflammatory disease, previous infection or those requiring revision hip surgery. Subjects with avascular necrosis Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used. Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell | Procedure: Total Hip Arthroplasty<br>* Surgical implantation of specific hip replacement components for treatment of osteoarthritis<br>|
| Active Comparator: 2<br>Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell | Procedure: Total Hip Arthroplasty<br>* Surgical implantation of specific hip replacement components for treatment of osteoarthritis<br>|
| Active Comparator: 3<br>Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell | Procedure: Total Hip Arthroplasty<br>* Surgical implantation of specific hip replacement components for treatment of osteoarthritis<br>|
| Active Comparator: 4<br>Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell | Procedure: Total Hip Arthroplasty<br>* Surgical implantation of specific hip replacement components for treatment of osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship: length of time implant remains without revision |  | Evaluated at 1,3,5,7 ,10th year over 10 years | 
| Complications and Adverse Events |  | Evaluated at 1,3,5,7 ,10th year over 10 years | 
| Incidence of radiolucencies (acetabular component) |  | Evaluated at 1,3,5,7 ,10th year over 10 years | 
| Patient administered Outcome Survey scores |  | Evaluated at 1,3,5,7 ,10th year over 10 years | 
| Polyethylene wear rates from AP radiographs |  | Evaluated at 1,3,5,7 ,10th year over 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship in subcategories of infection, aseptic loosening and other |  | 1,3,5,7,10 yr over 10 years | 
| Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life. |  | 1,3,5,7,10 yr over 10 years | 
| Other outcomes that may be relevant. |  | 1,3,5,7,10 yr over 10 years | 
| Retrieval analysis |  | 1,3,5,7,10 yr over 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship