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Synovial Biopsy for Shoulder Joint Infections

N/A

Waitlist Available

Led By Peter Lapner, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Revision shoulder surgery for patients described in (1)

Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty, or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operatively up to 5-years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a less invasive biopsy method can accurately detect infections in shoulder joints, in order to avoid more invasive surgery if it's not needed.

Who is the study for?

This trial is for individuals who've had previous shoulder surgery, like a total shoulder replacement, and now have signs of an infection such as fever or pain. They must be able to give consent and understand English/French. People with urgent infections needing immediate treatment or those with psychiatric conditions that affect informed consent are not eligible.

What is being tested?

The study is testing the accuracy of diagnosing shoulder infections using two methods: synovial biopsy (a less invasive procedure using a needle guided by x-ray) versus open tissue biopsy (a more invasive surgical method). The goal is to see if the less invasive method can reliably avoid unnecessary surgeries.

What are the potential side effects?

Potential side effects from the biopsies may include discomfort at the biopsy site, bleeding, infection risk from the procedure itself, and possible allergic reactions to materials used during either type of biopsy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a repeat shoulder surgery.

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I have had surgery on my shoulder, such as joint replacement or fracture repair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have signs of a severe infection that needs urgent treatment, preventing me from getting a joint tissue sample taken.

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I cannot speak or read English or French.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operatively up to 5-years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operatively up to 5-years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operatively up to 5-years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Reported Pain

Other study objectives

American Shoulder and Elbow Surgeons (ASES)

Constant Score

EQ-5D-5L

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Revision PopulationExperimental Treatment2 Interventions

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.

0 / 4Eligibility criteria met