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

NCT ID: NCT02208271

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 174 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-04
• Study Completion Date: 2030-12-31

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.

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.

Conditions

Arthritis, Failure of Total Hip

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

pre-operative total hip patients with no existing total hip implant

No interventions assigned to this group

Metal on polyethylene

patients who have a failed metal on polyethylene total hip implant and are presenting for revision surgery

No interventions assigned to this group

Metal on Metal

patients who have a failed metal on metal total hip implant and are presenting for revision surgery

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charlotte Orthopedic Hospital

OTHER

Sponsor Role: collaborator

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Fehring, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute, Inc.

Locations

OrthoCarolina

Charlotte, North Carolina, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

HK003-14014

Identifier Type: -

Identifier Source: org_study_id