Synovial Biopsy for Shoulder Joint Infections

Not currently recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting infections in the shoulder joint using a needle guided by x-ray, known as a synovial biopsy. The researchers aim to determine if this less invasive method can accurately detect infections compared to the traditional open biopsy performed during surgery. This approach could help avoid unnecessary surgeries if no infection is present. The trial seeks individuals who have undergone shoulder surgery and now experience symptoms like pain or stiffness that suggest an infection. Participants will undergo both the new biopsy method and the traditional one to compare results. As an unphased trial, this study offers participants the chance to contribute to medical advancements in diagnosing shoulder infections with less invasive techniques.

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 prior data suggests that the synovial biopsy technique is safe for diagnosing shoulder joint infections?

Research has shown that synovial biopsies, whether performed with a needle or through arthroscopy (using a small camera and tools inserted into the joint), are generally safe. Studies have found these procedures to be well-tolerated with few side effects. They are less invasive than open surgeries, typically involving smaller cuts and often allowing for easier recovery.

Open tissue biopsies are also regarded as safe and effective. They can yield good diagnostic results but require larger incisions during surgery, which may lead to a longer recovery time compared to the needle method.

Both methods aim to provide crucial information about potential infections in the shoulder. Synovial biopsies might help avoid more invasive surgery if no infection is present. Overall, both approaches are considered safe with manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about synovial biopsy for diagnosing shoulder joint infections because it offers a less invasive way to gather crucial information compared to traditional methods. While open tissue biopsies require more extensive surgical procedures, synovial biopsies can be performed with smaller incisions, potentially leading to quicker recovery and less discomfort for patients. This method could provide accurate diagnostic results by directly sampling the synovial fluid, which is often where infection indicators are most concentrated. By improving diagnostic accuracy and patient experience, synovial biopsy could become a valuable tool in the management of shoulder joint infections.

What evidence suggests that the synovial biopsy is effective for diagnosing shoulder joint infections?

Research has shown that a synovial biopsy can help identify shoulder joint infections. In this trial, participants will undergo both a synovial biopsy and an open tissue biopsy to compare diagnostic accuracy. One study found that synovial biopsy detected infections in 19% of patients, while a more invasive procedure during surgery confirmed infections in 23%. This suggests that synovial biopsy can be useful for spotting infections before surgery. Another study found that the more invasive procedure correctly identified infections 60% of the time. Both methods have their benefits, but synovial biopsy might help avoid unnecessary surgeries by confirming infections earlier. ^{1 2 6 7 8}

Who Is on the Research Team?

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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 am scheduled for a repeat shoulder surgery.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39389453/

Diagnostic accuracy of preoperative percutaneous synovial ... Results: Nineteen percent had positive infection based on PSB, and 23% had confirmed culture-positive infections based on intraoperative biopsy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324001737

Shoulder Rotator cuff The value of an open biopsy in ... The sensitivity of an open biopsy was 60% and the NPV was 83% among patients with a shoulder arthroplasty with no history of infection to predict infection ...

3. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00714-6/abstract

Diagnostic accuracy of preoperative percutaneous synovial ... The diagnostic accuracy of aspiration compared with open biopsy was as follows: sensitivity 0%, specificity 0.81 (95% CI 0.66-0.96), positive ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10499863/

Diagnostic arthroscopy for periprosthetic shoulder ... Arthroscopic biopsy in patients suspected of shoulder PJI has good diagnostic accuracy, with high sensitivity and specificity.

5. jsesinternational.org jsesinternational.org/article/S2666-6383(25)00063-5/fulltext

Accuracy of clinical symptoms and nuclear imaging in the ... Twenty-three percent of patients (n = 16) had confirmed culture positive infections based on the open biopsies. Sixty-four percent of patients ...

6. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00639-6/abstract

A systematic review of distinction of colonization and ... We analyzed data from 80 studies addressing the rates of C. acnes colonization/infection in patients undergoing shoulder surgery, evidence of an inflammatory ...

7. journal-cot.com journal-cot.com/article/S0976-5662(24)00189-9/fulltext

Management of periprosthetic joint infection of the shoulder There is new evidence that outcomes after revision shoulder arthroplasty are dependent on the virulence of the causative organism. An ...

8. mdpi.com mdpi.com/2077-0383/14/2/547

Mid- to Long-Term Outcomes of Two-Stage Revision ... Shoulder PJI and its treatment carry a high mortality risk, as evidenced by this study's mortality rate of approximately 35%. Notably, the two-stage revision ...