Status:
TERMINATED
Acetabular Bone Vascularity in Metal-on-Metal Revisions
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
Presbyterian Pathology Group
Conditions:
Failure of Total Hip
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs. A convenient sample of a co...
Detailed Description
Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked...
Eligibility Criteria
Inclusion
- Patients being revised for an aseptic metal on metal acetabular revision.
- Patient is greater than one year postoperative.
- Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
- Understands the local language and is willing and able to follow the requirements of the protocol.
- Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.
Exclusion
- History of infection
- Evidence of current substance or alcohol abuse
- Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
- Is a prisoner
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02239406
Start Date
November 1 2014
End Date
April 1 2016
Last Update
July 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoCarolina
Charlotte, North Carolina, United States, 28207