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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operatively up to 5 years.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Reported Pain

Other outcome measures

American Shoulder and Elbow Surgeons (ASES)

Constant Score

EQ-5D-5L

+2 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,573 Total Patients Enrolled

Peter Lapner, MDPrincipal InvestigatorThe Ottawa Hospital

12 Previous Clinical Trials

2,975 Total Patients Enrolled

Media Library

Revision Population Clinical Trial Eligibility Overview. Trial Name: NCT02143245 — N/A

Total Shoulder Replacement Research Study Groups: Revision Population

Total Shoulder Replacement Clinical Trial 2023: Revision Population Highlights & Side Effects. Trial Name: NCT02143245 — N/A

Revision Population 2023 Treatment Timeline for Medical Study. Trial Name: NCT02143245 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participants of this research study?

"This clinical trial stipulates that to be accepted as a participant, patients must meet the age criteria of 18 years or above and 90 years old or below."

Answered by AI

In which North American locations is this exploration taking place?

"The current enrolment of this trial is being conducted across 4 sites, with locations in Montréal, London and Toronto. For the convenience of participants, it is beneficial to select a clinic that minimizes travel requirements from their current residence."

Answered by AI

Is there an ongoing enrollment process for this clinical trial?

"Unfortunately, this clinical trial is not currently looking for participants. The first posting was on June 1st 2014 while the last edit occurred on July 1st 2022; however, there are many other medical studies actively recruiting right now with 774 entries listed in total."

Answered by AI

Is my profile compatible with the criteria set for this clinical trial?

"Those who have had a total shoulder arthroplasty and are between 18 to 90 years old may be eligible for this trial. Currently, 118 prospective patients are being sought after."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

2014. "Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02143245.

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