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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00208429 |
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-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.
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 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 System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement |
Estimated Enrollment: | 200 |
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 a cementless acetabular component and a metal on polyethylene bearing.
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) Subjects undergoing simultaneous bilateral hip operation.
iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
v) Women who are pregnant.
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 12 months.
viii) Subjects who are currently involved in any injury litigation claims.
Responsible Party: | DePuy International Ltd ( Michael Borroff, B.Sc., M.Sc. Study Director ) |
Study ID Numbers: | CT03/40 |
Study First Received: | September 13, 2005 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00208429 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Hip Cementless |
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 |