Status:
COMPLETED
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Biomet U.K. Ltd.
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.
Detailed Description
This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless to...
Eligibility Criteria
Inclusion
- Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
- Rheumatoid arthritis.
- Selection of subjects for this Evaluation should include the following considerations:
- Patients under 70 years of age.
- Willing to return for follow-up evaluations.
- No bias to sex.
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00757354
Start Date
June 1 2012
End Date
March 1 2014
Last Update
June 19 2017
Active Locations (1)
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1
Avon Orthopaedic Centre
Bristol, United Kingdom