Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

Study Overview
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Brief Summary
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The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

Detailed Description
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The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.

Official Title
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A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study

Conditions
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Non-inflammatory Degenerative Joint Disease

Intervention / Treatment
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* Device: ASR™-XL Modular Acetabular Cup System
* Device: Pinnacle™ acetabular shell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to or capable of providing consent to participate in the clinical investigation. Subject is between the ages of 20-75 years, inclusive. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD). Subject has sufficient bone stock for the hip replacement device. Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device. Exclusion Criteria: Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation. Subject with a known allergy to metal (e.g. jewelry). Subject has inflammatory arthritis (e.g. rheumatoid arthritis). Subject has active or recent joint sepsis. Subject with marked atrophy or deformity in the upper femur. Subject with a neuromuscular disease where the loss of musculature would affect functional outcome. Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis). Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery. Subject with known, active metastatic or neoplastic disease. Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser. Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>ASR™-XL Modular Acetabular Cup System stem | Device: ASR™-XL Modular Acetabular Cup System<br>* The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.<br>* Other names: Acetabular cup replacement;|
| Active Comparator: B<br>Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head. | Device: Pinnacle™ acetabular shell<br>* The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.<br>* Other names: Acetabular cup replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes | Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months | 24-month interval. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-Test of Harris Hip Total Score Means at 24 Months | T-Test of Harris Hip total score means at 24 months | 24 months | 
| Harris Hip Pain Sub Score at 24 Months | Mean Harris Hip Pain sub score | 24 months | 
| Harris Hip Function Score at 24 Months | Mean Harris Hip Function sub score at 24 months | 24 months | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | Pre-operative | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | pre-operative | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte cobalt | pre-operative | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte Chromium | Pre-operative | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | 4 months post-operative | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | 4 months post operative | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte Cobalt | 4 months post-operative | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte Chromium | 4 months post-operative | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | 12 months post-operative | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | 12 Months | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte Cobalt | 12 Months | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte Chromium | 12 months | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | 24 months | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | 24 months | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte Cobalt | 24 months | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte Chromium | 24 months | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | 36 months | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | 36 months | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte cobalt | 36 months | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte chromium | 36 months | 
| Analysis of Metal Ion Release - Serum Cobalt | Serum Cobalt | 48 months | 
| Analysis of Metal Ion Release - Serum Chromium | Serum Chromium | 48 months | 
| Analysis of Metal Ion Release - Erythrocyte Cobalt | Erythrocyte Cobalt | 48 months | 
| Analysis of Metal Ion Release - Erythrocyte Chromium | Erythrocyte chromium | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty, Acetabular cup replacement, Acetabulum arthroplasty