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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208364 |
The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis Osteoarthritis Post-Traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis |
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: | 200 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | March 2015 (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@its.jnj.com |
Italy | |
Ospedale Riuniti Di Bergamo | Active, not 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, B.Sc. M.Sc., Study Director ) |
Study ID Numbers: | CT01/11 |
Study First Received: | September 13, 2005 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00208364 History of Changes |
Health Authority: | Italy: National Institute of Health |
Hip Cementless Metal-on-Metal |
Autoimmune Diseases Osteonecrosis Collagen Diseases Hip Dislocation Osteoarthritis Dislocations Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin Rheumatic Diseases |
Bone Diseases Musculoskeletal Abnormalities Femoral Fractures Necrosis Musculoskeletal Diseases Epiphyses, Slipped Arthritis Connective Tissue Diseases Hip Dysplasia Leg Injuries Congenital Abnormalities Hip Dislocation, Congenital |
Autoimmune Diseases Immune System Diseases Collagen Diseases Osteonecrosis Osteoarthritis Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin Rheumatic Diseases Bone Diseases |
Musculoskeletal Abnormalities Femoral Fractures Necrosis Pathologic Processes Musculoskeletal Diseases Epiphyses, Slipped Arthritis Connective Tissue Diseases Leg Injuries Congenital Abnormalities Hip Dislocation, Congenital |