Synovial Biopsy for Shoulder Joint Infections

Recruiting at 4 trial locations

Overseen By Peter Lapner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Bacteremia, Sepsis, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

118 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Open Tissue Biopsy, Synovial Biopsy for shoulder joint infections?

Research shows that synovial biopsy can be valuable in diagnosing low-grade infections in shoulder joint replacements, which are often hard to detect. This suggests that synovial biopsy might be an effective tool for identifying infections in the shoulder joint. ^{1 2 3 4 5}

Is synovial biopsy safe for humans?

Synovial biopsy, whether done with a needle or through arthroscopy (a small camera and tools inserted into the joint), is generally considered safe. Studies have shown it to be a simple and safe procedure for analyzing joint tissue, with minimal risks when proper techniques are used. ^{1 6 7 8 9}

How does synovial biopsy differ from other treatments for shoulder joint infections?

Synovial biopsy is unique because it involves taking a small tissue sample from the joint lining to diagnose infections, which is less invasive and more accessible than traditional surgical methods. This approach is particularly useful for diagnosing low-grade infections in the shoulder, which are challenging to detect with other methods. ^{1 2 5 10 11}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Biopsy

Participants undergo a synovial biopsy to assess diagnostic accuracy for implant-related shoulder infections

1 day

1 visit (in-person)

Surgery and Open Biopsy

Participants undergo revision surgery and an open tissue biopsy is performed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for re-infection, functional outcomes, and quality of life

5 years

Treatment Details

Interventions

• Open Tissue Biopsy
• Synovial Biopsy

Trial Overview 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.

Participant Groups

Group I: Revision Population Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The significance of synovial biopsy in the diagnostic workup of the low-grade periprosthetic joint infection of shoulder arthroplasty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic tissue culture for the evaluation of periprosthetic shoulder infection. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Arthroscopy for Detection of Periprosthetic Infection in Painful Shoulder Arthroplasty. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Utility of prerevision tissue biopsy sample to predict revision shoulder arthroplasty culture results in at-risk patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

How accurate are positive preoperative aspiration culture results in shoulder periprosthetic joint infection? A concordance study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Synovial biopsy. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

US-Guided Biopsies: Overarching Principles. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Synovial tissue analysis in rheumatoid arthritis. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and safety in patients undergoing synovial biopsy: comparison of ultrasound-guided needle biopsy, ultrasound-guided portal and forceps and arthroscopic-guided synovial biopsy techniques in five centres across Europe. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Image-guided synovial biopsy with a focus on infection. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Needle biopsy of the synovium of children. [2013]