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Sponsors and Collaborators: |
Ottawa Health Research Institute Wright Medical Technology |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00253877 |
This study compares outcomes and metal ion levels between patients who receive the Conserve® Plus Hip System compared to those who have received a standard hip replacement in a recent study.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Device: Hip Resurfacing System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multi-Centre, Historical Control Trial Comparing the Conserve® Plus Resurfacing Hip System to Standard Total Hip Arthroplasty. |
Estimated Enrollment: | 200 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | July 2008 |
Total hip arthroplasty (THA) is currently the standard of care for end-stage degenerative joint disease of the hip. In this surgery, the entire joint is replaced by inserting an acetabular component into the pelvis, a femoral stem down the thigh bone (which has a ball on it to articulate in the acetabulum). However for the younger patient, long-term fixation and the prospect of mulitple revisions remain a notable concern. Long-term results of THA in this patient population have been disappointing. Studies cite failure rates of 21% to 33% at less than 10 years follow up. The Conserve Plus Hip System differs from total hip arthroplasty as it uses less bone stock from the femoral bone. The prosthesis is designed so that the head of the femoral bone is resurfaced rather than replaced. Consequently, bone stock of the femur is conserved. The bone conserving nature of this implant allows the surgeon to convert to a total hip arthroplasty with ease should a time arise when the patient requires revision arthroplasty. The Conserve Plus Hip System is also different from the THA as the bearing surface is metal on metal, rather than the conventional metal on polyethylene. This metal on metal bearing surface provides lower wear. Theoretically, this type of hip replacement may be a viable alternative to THA for the younger patient.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who are undergoing primary hip surgery for noninflammatory degenerative joint disease (NIDJD). Composite diagnoses for NIDJD include osteo/degenerative arthritis, traumatic arthritis, congenital hip dysplasia, and avascular necrosis.2. Patients who are skeletally mature or at least 18 years of age.3. Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow up period and for annual exams until the last patient entered into the study has achieved two years of follow-up.4. Patients who agree to participate and sign the informed consent form.5. Patients who do not meet any of the exclusion criteria.6. Patients who are already enrolled in the study and present with a need for revision of the metal femoral or acetabular resurfacing components. These patients may have the failed component(s) revised with an investigational component.
Exclusion Criteria:
Canada, Nova Scotia | |
QEII Health Sciences Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Contact: M Dunbar, MD, FRCS 902-473-7337 michael.dunbar.ort.lu.se | |
Contact: Sue Moore, CCRP 902-473-4128 sue.moore@cdha.nshealth.ca | |
Canada, Quebec | |
Hopital du Sacre-Coeur de Montreal | Recruiting |
Montreal, Quebec, Canada, H4J 1C5 | |
Contact: G Yves Laflamme, MD, FRCS 514-338-2222 ext 2060 orthofac@videotron.ca | |
Contact: Marie France Poirier, RN 514-338-2222 ext 3465 mariefrancepoirier@crhsc.umontreal.ca |
Principal Investigator: | Peter Lapner | OHRI |
Study ID Numbers: | OHREB 2003137-01H |
Study First Received: | November 10, 2005 |
Last Updated: | November 10, 2005 |
ClinicalTrials.gov Identifier: | NCT00253877 |
Health Authority: | Canada: Health Canada |
osteoarthritis hip resurfacing |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |