- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00253877
A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty
A Prospective, Multi-Centre, Historical Control Trial Comparing the Conserve® Plus Resurfacing Hip System to Standard Total Hip Arthroplasty.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 3A7
- QEII Health Sciences Centre
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
-
-
Quebec
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Montreal, Quebec, Canada, H4J 1C5
- Hôpital du Sacré-Cœur de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- . Patients who are less than 18 years of age or are skeletally immature at the time of surgery.2. Patients who present with inflammatory degenerative joint disease or revision surgery other than that specified in the inclusion criteria.3. Patients with previous fusions, acute femoral neck fractures and above knee amputations.4. Patients with evidence of active infection.5. Patients who are pregnant (or plan on becoming pregnant) or who are lactating.6. Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight bearing.7. Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar, or total hip replacement device.8. Patients with active hepatitis or HIV infection.9. Patients who otherwise meet the study criteria, but refuse to consent in writing to participate in the study. 10. Patients who are obese where obesity is defined as a Body Mass Index (BMI) >35.11. Patients with neuropathic joints.12. Patients with severe documented psychiatric disease.13. Patients requiring structural bone grafts.14. Patients with a documented allergy to cobalt chromium molybdenum.15. Patients with ipsilateral girdlestone.16. Patients with sickle cell disease.17. Patients with significant femoral head or neck deformity or significant acetabular wall deficiency.18. Patients with renal impairment where renal impairment is defined as serum creatinine> 180umol/L.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conserve Plus Hip Resurfacing
Conserve Plus Hip Resurfacing group.
Complication rate will be compared between groups.
|
All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology.
The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.
|
OTHER: Total Hip Replacement
Historical Total Hip Replacement control group of recently published conventional total hip replacement results (Williams, 2002).
Complication rate will be compared between groups.
|
All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology.
The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of complications
Time Frame: 2 years
|
Any complications pertaining specifically to the implant
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survivorship rate Clinical efficacy (Pain, Function, Radiographic outcome and Patient Satisfaction) Blood and Urine Ion Levels
Time Frame: 2 years
|
Clincial efficiency pertaining to the implant directly
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul Kim, MD, FRCS(C), OHRI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHREB 2003137-01H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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