Status:
TERMINATED
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 surge...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 18 and 65 years inclusive.
- ii) Subjects with current indications for standard 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
- 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.
- Additional Exclusion Criteria for Subjects Undergoing Blood Analysis
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium, titanium alloy.
- Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00872794
Start Date
November 1 2003
End Date
May 1 2010
Last Update
June 26 2017
Active Locations (1)
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1
St Augustine's Hospital
Durban, South Africa