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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208377 |
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 |
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 |
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) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Australia | |
Sportsmed SA | |
Stepney, Australia | |
Germany | |
Bundesknappshaft Klinik | |
Puettlingen, Germany | |
United Kingdom | |
Epsom General Hospital | |
Surrey, United Kingdom |
Study Director: | Michael Borroff, B.Sc., M.Sc. | DePuy International Ltd |
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 |
Hip Conservative Metal-on-Metal Resurfacing |
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 |
Pathologic Processes Immune System Diseases |