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Sponsored by: |
DePuy Orthopaedics |
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Information provided by: | DePuy Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00561600 |
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.
Condition | Intervention | Phase |
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Osteoporosis Arthritis Trauma |
Device: ASR™-XL Modular Acetabular Cup System Device: Pinnacle™ acetabular shell |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 400 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
ASR™-XL Modular Acetabular Cup System stem
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Device: ASR™-XL Modular Acetabular Cup System
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.
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B: Active Comparator
Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
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Device: Pinnacle™ acetabular shell
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.
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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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberly Guilbault | 574-372-7304 | KGuilbau@its.jnj.com |
United States, California | |
Desert Orthopaedics | Recruiting |
Rancho Mirage, California, United States, 92270 | |
United States, Georgia | |
Resurgens Orthopaedics | Recruiting |
Cumming, Georgia, United States, 30041 | |
United States, Illinois | |
Illinois Bone & Joint Institute | Recruiting |
Morton Grove, Illinois, United States, 60035 | |
Rush North Shore Hospital | Recruiting |
Skokie, Illinois, United States, 60076 | |
United States, Michigan | |
West Michigan Hip & Knee | Recruiting |
Grand Rapids, Michigan, United States, 49503-2550 | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756-0001 | |
United States, Oklahoma | |
Eastern Oklahoma Orthopedic Center | Recruiting |
Tulsa, Oklahoma, United States, 74136 | |
United States, Texas | |
Orthopaedic Specialists of Austin | Recruiting |
Austin, Texas, United States, 78705 | |
United States, Washington | |
Valley Medical Center | Recruiting |
Renton, Washington, United States, 98055 | |
Valley Orthopaedic Associates | Recruiting |
Renton, Washington, United States, 98055-5791 |
Study Director: | Kimberly Guilbault | DePuy Orthopaedics, Inc. |
Responsible Party: | DePuy Orthopaedics, Inc. ( Kimberly Guilbault ) |
Study ID Numbers: | 04062 |
Study First Received: | November 20, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00561600 |
Health Authority: | United States: Institutional Review Board |
Hip arthroplasty Acetabular cup replacement Acetabulum arthroplasty |
Musculoskeletal Diseases Joint Diseases Arthritis Wounds and Injuries |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |