A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty

Stopped early

Conditions studied: Arthritis, Failure of Total Hip

In brief

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 facts

Study ID

NCT02208271

Run by

OrthoCarolina Research Institute, Inc.

People needed

174

Starts

2014-08-04

Expected to finish

2020-08-12

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• OrthoCarolina — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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