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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208455 |
A post-market surveillance study to evaluate survivorship, and clinical and radiological performance of the DePuy PROXIMA™ hip
Condition | Intervention | Phase |
---|---|---|
Primary Osteoarthritis Secondary Osteoarthritis Avascular Necrosis Developmental Dysplasia of the Hip |
Device: DePuy Proxima™ Hip |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Uncontrolled, Multi-Centre, Prospective, Post Marketing Surveillance Study to Monitor the Long Term Survivorship of the DePuy PROXIMA™ Hip in Subjects Requiring a Total Hip Replacement |
Estimated Enrollment: | 200 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | November 2013 (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 between 18 and 70 years of age.
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 agree to return to the hospital for all the required post-operative follow-ups.
iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study.
ii) Women who are pregnant.
iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
v) Subjects who are currently involved in any injury litigation claims.
vi) Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip.
vii) Subjects undergoing a simultaneous bilateral hip operation.
viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Contact: Michael Borroff, B.Sc., M.Sc. | +44 113 387 7800 ext 7910 | mborroff@dpygb.jnj.com |
Germany | |
Asklepios Klinikum | Active, not recruiting |
Bad Abbach, Germany | |
Italy | |
Ospedale San Pietro | Active, not recruiting |
Rome, Italy | |
Spain | |
Arnau de Vilanova | Active, not recruiting |
Valencia, Spain | |
United Kingdom | |
North Bristol NHS Trust | Recruiting |
Bristol, United Kingdom |
Study Director: | Michael Borroff, B.Sc., M.Sc. | DePuy International Ltd. |
Responsible Party: | DePuy International ( Michael Borroff ) |
Study ID Numbers: | CT03/09 |
Study First Received: | September 13, 2005 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00208455 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Arthroplasty, Replacement, Hip Conservative Anatomic Cementless |
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 |