Clinical trial NCT02143245: Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
Official title: Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Shoulder Arthroplasty
Keywords: Shoulder Infection
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)
timeFrame: Pre-operatively.
Secondary outcomes:
measure: Reported Pain
timeFrame: 24-hours after biopsy.
Other outcomes:
measure: Rates of Re-Infection
timeFrame: Post-Operatively up to 5 years.
measure: Constant Score
timeFrame: Post-operatively up to 5-years.
measure: Western Ontario Osteoarthritis of the Shoulder (WOOS)
timeFrame: Post-operatively up to 5-years.
measure: American Shoulder and Elbow Surgeons (ASES)
timeFrame: Post-operatively up to 5-years.
measure: EQ-5D-5L
timeFrame: Post-operatively up to 5-years.
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Sacré-Coeur Hospital of Montreal
state: Quebec
Study officials:
affiliation: The Ottawa Hospital
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References: