NCT02143245

Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2022-12-01
• Completion: 2027-12-01
• First posted: 2014-05-21
• Last updated: 2024-04-30

Locations

4 sites across 1 country: Canada