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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Total Shoulder Arthroplasty | Other: percutaneous synovial biopsy | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: percutaneous synovial biopsy |
Other: percutaneous synovial biopsy |
- 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).
- To determine the correlation and agreement of shoulder synovial biopsy results with other indices of infection [ Time Frame: Pre-Operatively ]

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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 |
Inclusion Criteria:
- Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures
- Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively
- Revision shoulder surgery for patients described in (1)
- Provide consent
Exclusion Criteria:
- signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent

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
Contact: Peter Lapner, MD | 613-737-8899 ext 78377 | ||
Contact: Kimberly Paquin, BA | 613-737-8920 |
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 |
Principal Investigator: | Peter Lapner, MD | The Ottawa Hospital |
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 |