Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Sponsor: OrthoCarolina Research Institute, Inc.
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 convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
174
Start Date
2014-08-04
Completion Date
2020-08-12
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Locations (1)
OrthoCarolina
Charlotte, North Carolina, United States