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Sponsors and Collaborators: |
University of Aarhus Biomet Merck Aps,Horsens, Denmark Gigtforeningen,Gentoftegade 118, Gentofte, Denmark Sahva A/S, Borgervænget 5-7, København Ø, Denmark Danske Fysioterapeuter,Nørre Voldgade 90, København, Denmark Silkeborg Hospital, Denmark The Finnish Institute of Occ. Health Biomonitoring Lab., Helsinki, Finland Hammel Neurocenter, Hammel, Denmark |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00116948 |
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
Condition | Intervention | Phase |
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Osteoarthrosis |
Device: ReCap, Hip resurfacing system, Biomet |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter |
Estimated Enrollment: | 50 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of hip implantation is low. Unfortunately, this is not true for younger patients. Approximately 20% of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years.
This is primarily because of the wear generated by polyethylene debris. The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis. This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people. The new prosthesis should produce less inflammatory debris and less osteolysis induced failure.
To avoid the polyethylene particles, a new type of prosthesis has been made articulating metal on metal. The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum. Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual.
This will theoretically participate in the generation of metal ions.
Study objectives:
Ages Eligible for Study: | 50 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, Jylland | |
Orthopaedic Center, Aarhus University Hospital | |
Aarhus, Jylland, Denmark, 8000 |
Principal Investigator: | Kjeld Søballe, MD., Prof. | Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark |
Responsible Party: | Aarhus University Hospital ( Professor Kjeld Søballe ) |
Study ID Numbers: | 20030289 |
Study First Received: | June 30, 2005 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00116948 History of Changes |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Osteoarthrosis RSA DEXA Hip arthroplasty |
Metal ion Inflammatory response Gait analysis |
Musculoskeletal Diseases Osteoarthritis Arthritis |
Joint Diseases Rheumatic Diseases Cimetidine |
Musculoskeletal Diseases Osteoarthritis Arthritis Joint Diseases Rheumatic Diseases |