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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208364 |
A post-market surveillance study to evaluate survivorship, clinical and radiological performance of the Pinnacle TM cup with a Metal-on-Metal bearing.
Condition | Intervention | Phase |
---|---|---|
Primary Osteoarthritis Secondary Osteoarthritis Avascular Necrosis Developmental Dysplasia of the Hip |
Device: Pinnacle Acetabular Cup System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement |
Estimated Enrollment: | 300 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Male or female subjects, aged between 18 and 70 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.
iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
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 undergoing revision hip replacement.
iii) Women who are pregnant.
iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
vi) Subjects who are currently involved in any injury litigation claims.
Additional Exclusion Criteria for Subjects Having Blood Analysis:
Contact: Michael Borroff, B.Sc., M.Sc. | +44 113 387 7800 ext 7910 | mborroff@dpygb.jnj.com |
Italy | |
Ospedale Riuniti Di Bergamo | Recruiting |
Bergamo, Italy | |
United Kingdom | |
Royal Orthopaedic Hospital | Recruiting |
Birmingham, United Kingdom |
Study Director: | Michael Borroff, B.Sc., M.Sc. | DePuy International Ltd. |
Responsible Party: | DePuy International Ltd ( Michael Borroff ) |
Study ID Numbers: | CT01/11 |
Study First Received: | September 13, 2005 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00208364 |
Health Authority: | Italy: National Institute of Health |
Hip Cementless Metal-on-Metal |
Osteonecrosis Hip Dislocation Osteoarthritis Dislocations Joint Diseases Rheumatic Diseases Bone Diseases Musculoskeletal Abnormalities |
Necrosis Musculoskeletal Diseases Arthritis Neoplasm Metastasis Congenital Abnormalities Hip dislocation Hip Dislocation, Congenital |
Pathologic Processes |