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Sponsored by: |
Alberta Bone and Joint Health Institute |
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Information provided by: | Alberta Bone and Joint Health Institute |
ClinicalTrials.gov Identifier: | NCT00293774 |
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Provincial Initiative to Examine the Efficacy, Cost-Effectiveness and Long-Term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip |
Blood samples retained for cobalt and chromium metal ion level analysis on select cohort.
Estimated Enrollment: | 1000 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | September 2014 |
Groups/Cohorts |
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Standard
Standard hip replacement subjects (polyethylene)
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Alternative Bearing
Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing.
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This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Males and Females between the ages of 18-65
Inclusion Criteria:
Exclusion Criteria:
Contact: Leslie Dort | 430-670-0886 | info@albertaboneandjoint.com |
Contact: Peter Faris | 403-670-0886 | info@albertaboneandjoint.com |
Canada, Alberta | |
Alberta Bone and Joint Health Institute | Recruiting |
Calgary, Alberta, Canada, T2N 2X6 |
Principal Investigator: | Cyril B Frank, M.D. | University of Calgary |
Principal Investigator: | Greg O'Connor, MD | University of Alberta |
Responsible Party: | Alberta Bone and Joint Health Insitute ( Alberta Bone and Joint Health Insitute ) |
Study ID Numbers: | ABHIP-00001 |
Study First Received: | February 16, 2006 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00293774 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Prospective Conventional therapy Registry |
Metal-on-metal Ceramic-on-ceramic Hip Arthroplasty |
Osteoarthritis Joint Diseases |