Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

NCT ID: NCT02143245

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2027-12-31

Brief Summary

The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. Some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.

Detailed Description

The primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (IISI).

The secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection.

The third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery.

The fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates.

The fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of IISI.

It is our hypothesis that synovial biopsy is valid tool for use in the diagnosis of shoulder arthroplasty and fracture implant related infections.

Conditions

Total Shoulder Arthroplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Revision Population

The study population is both men and women who have had previous shoulder surgery with symptoms suggestive of deep infection. These include the presence of pain, stiffness, and radiologic signs of infection including implant lucencies or migration.

Patients in this population will undergo a synovial biopsy, in addition to undergoing an open tissue biopsy at the time of their procedure. Diagnostic accuracy will be compared, and all participants will be tracked over time.

Group Type: OTHER

Synovial Biopsy

Intervention Type: DIAGNOSTIC_TEST

Synovial biopsy is a procedure using a guided needle, where 6 to 8 small tissue samples with be extracted from the shoulder using an x-ray guided needle.

Open Tissue Biopsy

Intervention Type: DIAGNOSTIC_TEST

During the standard of care revision surgery, 6 to 8 small tissue samples will be taken in order to test for infection. This is standard of care treatment. As part of this study, an additional 1 to 2 samples of tissue would be taken in order to develop a test to determine more precisely what type of infection there may be.

Interventions

Synovial Biopsy

Synovial biopsy is a procedure using a guided needle, where 6 to 8 small tissue samples with be extracted from the shoulder using an x-ray guided needle.

Intervention Type: DIAGNOSTIC_TEST

Open Tissue Biopsy

During the standard of care revision surgery, 6 to 8 small tissue samples will be taken in order to test for infection. This is standard of care treatment. As part of this study, an additional 1 to 2 samples of tissue would be taken in order to develop a test to determine more precisely what type of infection there may be.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures

2. Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively

3. Revision shoulder surgery for patients described in (1)

4. Provide consent

Exclusion Criteria

1. signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy

2. Unable to speak or read English/French

3. Psychiatric illness that precludes informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

St. Joseph's Health Care London

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Sacré-Coeur Hospital of Montreal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

20140167-01H

Identifier Type: -

Identifier Source: org_study_id