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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.
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 1, 2014
Primary Completion Date
December 1, 2022
Completion Date
December 1, 2027
Last Updated
April 30, 2024
118
ACTUAL participants
Synovial Biopsy
DIAGNOSTIC_TEST
Open Tissue Biopsy
DIAGNOSTIC_TEST
Lead Sponsor
Ottawa Hospital Research Institute
NCT06143306
NCT07145957
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06733480