Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

NCT02143245 | Active Not Recruiting

• 1 other identifier: 20140167-01H
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

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.

Conditions

Total Shoulder Arthroplasty

Keywords

Shoulder Infection

Outcome Measures

Primary Outcomes (1)

• Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)

  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).

  Pre-operatively.

Secondary Outcomes (1)

• Reported Pain

  24-hours after biopsy.

Other Outcomes (5)

• Rates of Re-Infection

  Post-Operatively up to 5 years.

• Constant Score

  Post-operatively up to 5-years.

• Western Ontario Osteoarthritis of the Shoulder (WOOS)

  Post-operatively up to 5-years.

Study Arms (1)

Revision Population

OTHER

The study population is both men and women who have had previous shoulder surgery with symptoms suggestive of deep infection. These include the presence of pain, stiffness, and radiologic signs of infection including implant lucencies or migration. Patients in this population will undergo a synovial biopsy, in addition to undergoing an open tissue biopsy at the time of their procedure. Diagnostic accuracy will be compared, and all participants will be tracked over time.

Diagnostic Test: Synovial Biopsy; Diagnostic Test: Open Tissue Biopsy

Interventions

Synovial Biopsy DIAGNOSTIC_TEST

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.

Revision Population

Open Tissue Biopsy DIAGNOSTIC_TEST

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.

Revision Population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (4)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Sacré-Coeur Hospital of Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Study Officials

• Peter Lapner, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: May 21, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CA (4)