Status:
SUSPENDED
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
Charlotte Orthopedic Hospital
Conditions:
Arthritis, Failure of Total Hip
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenienc...
Detailed Description
Well-functioning MoM implants have shown an increase in serum cobalt and chromium (CoCr) ion levels from the metal debris generated from the implant wear.However, the current evidence suggests that me...
Eligibility Criteria
Inclusion
- Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested within 6 months of the date of the planned revision surgery.
- Patients presenting for a metal on poly hip revision
- Revision hip patients must be greater than one year postoperative
- The diagnosis at the time of the index, or primary, hip replacement was osteoarthritis.
- Patients who have hip osteoarthritis but have not had a total hip surgery (control)
Exclusion
- Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested \>6 months of the date of the planned revision
- Patients with a total hip on the contralateral side.
- Patients with a prior history of periprosthetic infection
- Revision cases where the diagnosis at the time of the index, or primary, hip replacement was not osteoarthritis.
- Prisoners
- Patients not willing to consent for the proposed treatment
- Patients with an altered mental status
- Active, concurrent metastatic infection
- Active, superficial infection
- Patients presenting for a metal on poly hip revision to treat trunionosis
Key Trial Info
Start Date :
August 4 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2030
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT02208271
Start Date
August 4 2014
End Date
December 31 2030
Last Update
April 30 2025
Active Locations (1)
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1
OrthoCarolina
Charlotte, North Carolina, United States, 28207