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ACTIVE NOT RECRUITING
NCT02143245
NA

Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2014-06

Completion Date

2027-12

Last Updated

2024-04-30

Healthy Volunteers

No

Interventions

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.

Locations (4)

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