Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

Ottawa Hospital Research Institute

Status: Active, not recruiting

Conditions: Total Shoulder Arthroplasty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02143245

20140167-01H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

118 participants in 1 patient group

Revision Population

Other group

Description:

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.

Treatment:

Diagnostic Test: Open Tissue Biopsy

Diagnostic Test: Synovial Biopsy