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

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ClinicalTrials.gov Identifier: NCT02208271
Recruitment Status : Suspended (The lab was acquired by another company and has put this study's samples on hold.)
First Posted : August 5, 2014
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Charlotte Orthopedic Hospital
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief 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.


Condition or disease
Arthritis, Failure of Total Hip

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.

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Study Type : Observational
Actual Enrollment : 174 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Actual Study Start Date : August 4, 2014
Actual Primary Completion Date : May 17, 2018
Estimated Study Completion Date : December 31, 2021

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208271


Locations
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United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Charlotte Orthopedic Hospital
Investigators
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Principal Investigator: Thomas Fehring, MD OrthoCarolina Research Institute, Inc.
Publications:

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02208271    
Other Study ID Numbers: HK003-14014
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Keywords provided by OrthoCarolina Research Institute, Inc.:
tissue necrosis
metal on metal total hip
biomarker
Additional relevant MeSH terms:
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Necrosis
Pathologic Processes