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A Multi-Centre Study to Assess the Long-Term Survivorship and Performance of the DePuy ASR ™ Hip System in Subjects Requiring a Primary Resurfacing Hip Arthroplasty
This study is ongoing, but not recruiting participants.
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208377
  Purpose

A post-market surveillance study to evaluate the survivorship, clinical and radiological performance of the DePuy ASR ™ Hip System


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Post-Traumatic Arthritis
Avascular Necrosis
Developmental Dysplasia of the Hip
Protrusio
Device: DePuy ASR Hip System
Phase IV

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Prospective Multi-Centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-Term Performance of the DePuy ASR Hip System in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated annually [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Harris Hip Score, UCLA Activity Score, WOMAC Score and Radiographic analysis [ Time Frame: Harris Hip Score and Radiographic analysis 3 months, 1 year, 2 years, 5 years, 10 years, and 15 years. UCLA Activity Score and WOMAC Score 3 months, 6 months and annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2003
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DePuy ASR Hip System
    A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

ii) Subjects with current indications for standard metal-on-metal (MoM) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.

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

iv) 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.

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 proven significant osteoporosis and poor bone quality.

iii) Subjects with compromised renal function.

iv) Subjects with proven metal sensitivity.

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

vi) Women who are pregnant.

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

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

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208377

Locations
Australia
Sportsmed SA
Stepney, Australia
Germany
Bundesknappshaft Klinik
Puettlingen, Germany
United Kingdom
Epsom General Hospital
Surrey, United Kingdom
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael Borroff, B.Sc., M.Sc. DePuy International Ltd
  More Information

Responsible Party: Michael Borroff ( Michael Borroff )
Study ID Numbers: CT01/21
Study First Received: September 13, 2005
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00208377  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Hip
Conservative
Metal-on-Metal
Resurfacing

Study placed in the following topic categories:
Autoimmune Diseases
Osteonecrosis
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases
Musculoskeletal Abnormalities
Necrosis
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Congenital Abnormalities
Hip dislocation
Hip Dislocation, Congenital

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009