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Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872547
Recruitment Status : Terminated (DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study)
First Posted : March 31, 2009
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
DePuy International

Brief Summary:

The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study.

Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links and

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis Device: DePuy ASR™ Hip System Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty
Study Start Date : September 2006
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: 1
Resurfacing system
Device: DePuy ASR™ Hip System
Resurfacing system

Active Comparator: 2
Large Metal-on-Metal Total Hip Replacement
Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Large Metal-on-Metal Total Hip Replacement

Primary Outcome Measures :
  1. Kaplan-Meier survivorship calculated at the five-year time-point [ Time Frame: 5yrs ]

Secondary Outcome Measures :
  1. Annual Kaplan-Meier survivorship calculations [ Time Frame: Annually ]
  2. Harris Hip Score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery ]
  3. Radiographic analysis [ Time Frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery ]
  4. Oxford Hip Score [ Time Frame: 3mths, 6mths and annually post-surgery ]
  5. UCLA Activity Score [ Time Frame: 3mths, 6mths and annually post-surgery ]
  6. Hip Outcome Score [ Time Frame: 3mths, 6mths and annually post-surgery ]
  7. EuroQol EQ-5D [ Time Frame: 3mths, 6mths and annually post-surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

General Inclusion Criteria:

i) Male or female subjects, aged between 18 and 65 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Inclusion Criteria for DePuy ASR™ Resurfacing system:

i) Subjects with primary osteoarthritis indicated for standard MoM hip resurfacing arthroplasty with cementless fixation in the acetabulum.

Inclusion Criteria for ASR™ XL Head system:

i) Subjects whose bone morphology and bone quality mean that standard MoM hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large MoM bearing are still possible.

General Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.

iii) Subjects with proven metal sensitivity.

iv) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.

v) Women who are pregnant or who intend to become pregnant within 2 years of surgery.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

viii) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.

ix) Subjects who are currently involved in any injury litigation claims.

x) Subjects who are undergoing corticosteroid treatment.

xi) Subjects with active or recent joint sepsis.

Additional Exclusion Criteria for DePuy ASR™:

i) Subjects with proven significant osteoporosis and poor bone quality.

ii) Subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.

iii) Subjects whose anatomical CCD angle is below 120°.

iv) Subjects who have undergone irradiation of the affected hip.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872547

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University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
Graz, Austria
Czech Republic
Znojmo Hospital
Znojmo, Czech Republic
Coxa, Hospital for Joint Replacement
Tampere, Finland
Klinikum der Universität zu
Köln, Germany
Elverum Hospital
Elverum, Norway
Hospital Curry Cabral
Lisboa, Curry Cabral, Portugal
Kant. Spital Sursee-Wolhusen
Wolhusen, Switzerland
United Kingdom
Royal Berkshire Hospital, UK
Reading, Berkshire, United Kingdom
Sponsors and Collaborators
DePuy International

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Responsible Party: DePuy International Identifier: NCT00872547     History of Changes
Other Study ID Numbers: CT05/18
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016

Keywords provided by DePuy International:
Large Heads
XL Head
ASR - osteoarthritis (primary)

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fractures, Bone
Wounds and Injuries
Leg Injuries
Joint Dislocations
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped