Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
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Purpose
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 |
|---|---|---|
|
Osteoporosis Arthritis Trauma |
Device: ASR™-XL Modular Acetabular Cup System Device: Pinnacle™ acetabular shell |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
- Composite success based upon Harris Hip Score, Radiographic and Survivorship Outcomes [ Time Frame: Pre-operative, 1, 4, 12, and 24-month intervals and annually until all subjects had their 24-month evaluation. ] [ Designated as safety issue: Yes ]
| Enrollment: | 300 |
| Study Start Date: | August 2006 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
ASR™-XL Modular Acetabular Cup System stem
|
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.
Other Name: Acetabular cup replacement
|
|
Active Comparator: B
Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
|
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.
Other Name: Acetabular cup replacement
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Desert Orthopaedics | |
| Rancho Mirage, California, United States, 92270 | |
| United States, Georgia | |
| Resurgens Orthopaedics | |
| Cumming, Georgia, United States, 30041 | |
| United States, Illinois | |
| Rush North Shore Hospital | |
| Skokie, Illinois, United States, 60076 | |
| United States, Michigan | |
| Spectrum Health Hospital Research | |
| Grand Rapids, Michigan, United States, 49503-2550 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, Oklahoma | |
| Eastern Oklahoma Orthopedic Center | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Texas | |
| Orthopaedic Specialists of Austin | |
| Austin, Texas, United States, 78705 | |
| United States, Washington | |
| Valley Medical Center | |
| Renton, Washington, United States, 98055 | |
| Valley Orthopaedic Associates | |
| Renton, Washington, United States, 98055-5791 | |
| Study Director: | Dave Whalen, BS, DC | DePuy Orthopaedics |
More Information
No publications provided
| Responsible Party: | DePuy Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00561600 History of Changes |
| Other Study ID Numbers: | 04062 |
| Study First Received: | November 20, 2007 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by DePuy Orthopaedics:
|
Hip arthroplasty Acetabular cup replacement Acetabulum arthroplasty |
Additional relevant MeSH terms:
|
Arthritis Osteoporosis Joint Diseases |
Musculoskeletal Diseases Bone Diseases, Metabolic Bone Diseases |
ClinicalTrials.gov processed this record on June 17, 2013