Status:
WITHDRAWN
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
Lead Sponsor:
Northwell Health
Conditions:
Hip Replacement
Hip Implant
Eligibility:
All Genders
40-80 years
Brief Summary
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing sur...
Detailed Description
This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing sur...
Eligibility Criteria
Inclusion
- Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.
- Patient must be able to provide consent to participate
Exclusion
- Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition
- Evidence of active infections
- Patients whose occupations include welding or metal working
- A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation
- unwillingness to comply with rehabilitation program or inability to return for follow-up visits
- Any systemic steroid therapy within 3 months of surgery
- Subjects who are pregnant
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00883805
Start Date
April 1 2009
Last Update
September 17 2015
Active Locations (1)
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1
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030