- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208377
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
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
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.
DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from December 2010 to allow for the completion of the 5 year follow up assessments.
Please note that subsequent 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 http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and http://www.depuy.com/countries_list.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Stepney, Australia
- Sportsmed Sa
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Puettlingen, Germany
- Bundesknappshaft Klinik
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Surrey, United Kingdom
- Epsom General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: DePuy ASR Hip System
A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
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A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Kaplan-Meier survivorship calculated annually
Time Frame: Annually
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Annually
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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UCLA Activity Score
Time Frame: 3 months, 6 months and then annually
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3 months, 6 months and then annually
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WOMAC Score
Time Frame: 3 months, 6 months and then annually
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3 months, 6 months and then annually
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Activity Assessment
Time Frame: 3 months, 6 months and then annually
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3 months, 6 months and then annually
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Harris Hip Score
Time Frame: 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
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3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
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Radiographic analysis
Time Frame: pre-discharge, 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
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pre-discharge, 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
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Metal ion analysis in whole blood
Time Frame: 3mths, 1yr, 2yrs and 5yrs post surgery
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3mths, 1yr, 2yrs and 5yrs post surgery
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Bone mineral density (DEXA)
Time Frame: pre-discharge, 3mths, 1yr, 2yrs and 5yrs post-surgery
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pre-discharge, 3mths, 1yr, 2yrs and 5yrs post-surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Fractures, Bone
- Wounds and Injuries
- Leg Injuries
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Hip Injuries
- Musculoskeletal Abnormalities
- Joint Dislocations
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Epiphyses, Slipped
- Femoral Fractures
- Arthritis
- Necrosis
- Rheumatic Diseases
- Collagen Diseases
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Slipped Capital Femoral Epiphyses
Other Study ID Numbers
- CT01/21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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