Status:
TERMINATED
Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement
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 of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surge...
Eligibility Criteria
Inclusion
- General
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00872547
Start Date
September 1 2006
End Date
November 1 2011
Last Update
August 4 2016
Active Locations (8)
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1
University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
Graz, Austria
2
Znojmo Hospital
Znojmo, Czechia
3
Coxa, Hospital for Joint Replacement
Tampere, Finland
4
Klinikum der Universität zu
Cologne, Germany