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

April 1, 2024 updated by: OrthoCarolina Research Institute, Inc.

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.

Study Overview

Status

Suspended

Conditions

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 measuring ion levels is unreliable and that increasing ion levels do not correlate with tissue damage. In addition to measuring blood and synovial fluid metal ion levels, ultrasound and MRI with metal artifact reduction sequences (MARS) have been utilized to assess periarticular reactions secondary to metal wear debris. Despite metal reduction software these scans are frequently difficult to interpret. While each of these tests has merit, at the present time there is no single diagnostic test available which delineates the key issue that demands urgent surgical intervention, i.e. tissue necrosis. It is important to have a reliable test to guide surgeons and patients in the shared decision-making process of when surgical intervention is necessary to prevent disabling tissue damage. For this reason, the current study proposes an examination of preoperative serum samples of subjects in addition to synovial fluid collected during revision surgery for biomarkers that may indicate tissue necrosis. To maximize the chance of success of identifying serum biomarkers, all samples will be analyzed using multianalyte assay, biomarker tests. 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.

Study Type

Observational

Enrollment (Actual)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A convenience sample of a total of 100 hip patients will be enrolled at orthopedic clinics.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
pre-operative total hip patients with no existing total hip implant
Metal on polyethylene
patients who have a failed metal on polyethylene total hip implant and are presenting for revision surgery
Metal on Metal
patients who have a failed metal on metal total hip implant and are presenting for revision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with serum and synovial fluid biomarkers
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 2 hours
Blood Serum and Synovial fluid will be tested using a multi-analyte assay test
participants will be followed for the duration of their hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with tissue necrosis
Time Frame: participants will be followed for the duration of their hospital stay, an expected average of 2 hours

Tissue necrosis will be assessed during total hip surgery.

Tissue necrosis will be scored in subsets including: intraoperative tissue damage, histological necrosis score, histologic ALVAL score, inflammatory infiltrate, and tissue organization
participants will be followed for the duration of their hospital stay, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Collaborators

Charlotte Orthopedic Hospital

Investigators

  • Principal Investigator: Thomas Fehring, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2014

Primary Completion (Actual)

May 17, 2018

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimated)

August 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK003-14014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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