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Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

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ClinicalTrials.gov Identifier: NCT02143245
Recruitment Status : Recruiting
First Posted : May 21, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Total Shoulder Arthroplasty Other: percutaneous synovial biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: percutaneous synovial biopsy Other: percutaneous synovial biopsy


Outcome Measures
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Primary Outcome Measures :
  1. diagnostic accuracy of percutaneous synovial biopsy [ Time Frame: Pre-operatively ]

    To assess the diagnostic accuracy of percutaneous synovial biopsy (test procedure) for detection of implant-related intraarticular shoulder infections (IISI), in comparison to direct macroscopic synovial biopsy, from either arthroscopic or open procedures (the reference standard).

    To address the primary objective, standard diagnostic accuracy statistics (sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio) will be derived, comparing lab results from percutaneous synovial biopsy specimen collection to those of the reference standard test (open/arthroscopic).



Secondary Outcome Measures :
  1. To determine the correlation and agreement of shoulder synovial biopsy results with other indices of infection [ Time Frame: Pre-Operatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143245


Contacts
Contact: Peter Lapner, MD 613-737-8899 ext 78377
Contact: Kimberly Paquin, BA 613-737-8920

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Peter Lapner, MD    613-737-8899 ext 78377      
Principal Investigator: Peter Lapner, MD         
Sub-Investigator: Adnan Sheikh, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Peter Lapner, MD The Ottawa Hospital
More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02143245     History of Changes
Other Study ID Numbers: 20140167-01H
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018