Alberta Hip Improvement Project
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Purpose
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: | Observational Model: Cohort Time Perspective: 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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Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Males between the ages of 18-65 and females between the ages of 18-55
Inclusion Criteria:
- documentation of DJD of hip
- patient at least 18 years
- patient able to provide written consent
- Male under 65 years, female under 56 years
- Orthopedic surgeon has received appropriate training to implant an alternative device
Exclusion Criteria:
- renal failure (MOM only)
- child bearing potential (MOM only)
- inappropriate femoral anatomy, including evidence of osteoporosis
- inflammatory arthritis (MOM)
- Unwilling to consent
Contacts and Locations| Contact: Robyn Parker | 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: | James MacKenzie, M.D. | University of Calgary |
| Principal Investigator: | Greg O'Connor, MD | University of Alberta |
More Information
No publications provided
| Responsible Party: | Alberta Bone and Joint Health Insitute |
| ClinicalTrials.gov Identifier: | NCT00293774 History of Changes |
| Other Study ID Numbers: | ABHIP-00001 |
| Study First Received: | February 16, 2006 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Alberta Bone and Joint Health Institute:
|
Prospective Conventional therapy Registry |
Metal-on-metal Ceramic-on-ceramic Hip Arthroplasty |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013