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

NCT02208271 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Arthritis, Failure of Total Hip

Sponsors & Collaborators

  • Charlotte Orthopedic Hospital

    collaborator OTHER

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Thomas Fehring, MD · OrthoCarolina Research Institute, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-04
Primary Completion
2018-05-17
Completion
2020-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208271 on ClinicalTrials.gov