Synovial Biopsy for Shoulder Joint Infections

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byPeter Lapner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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.

Inclusion Criteria

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

I am scheduled for a repeat shoulder surgery.

Provide consent

See 1 more

Exclusion Criteria

Psychiatric illness that precludes informed consent

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

I cannot speak or read English or French.

Treatment Details

Interventions

Open Tissue Biopsy (Procedure)
Synovial Biopsy (Procedure)

Trial OverviewThe 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.

Participant Groups

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.