Status:
COMPLETED
RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Stryker Trauma and Extremities
Conditions:
Hip Joint
Osteoarthritis
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the ...
Detailed Description
The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-C...
Eligibility Criteria
Inclusion
- Individuals undergoing unilateral total hip replacement.
- Patients 50 to 70 years of age.
Exclusion
- Patients who have previously undergone any type of joint replacement.
- Patients with evidence of active infection.
- Patients with a documented allergy to cobalt chromium molybdenum.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00911599
Start Date
August 1 2006
End Date
May 1 2013
Last Update
March 4 2020
Active Locations (1)
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1
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6