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Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis

RecruitingNAAges any - 17 YearsAllHospital for Special Surgery, New York
NCT03704766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Differentiating between septic arthritis and other causes of joint inflammation in pediatric patients is challenging and of the utmost importance because septic arthritis requires surgical debridement as part of the treatment regimen. The current gold standard to diagnose septic arthritis in children is a positive synovial fluid culture; however, joint cultures may take several days to return. If a bacterial infection is present, it requires immediate surgical intervention in order to prevent lasting articular cartilage damage. Frequently surgeons must decide whether to surgically debride a joint before culture results are available. There is no single lab test or clinical feature that reliably indicates bacterial infection over other causes of joint inflammation. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this

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📋 Eligibility rules (as published)
Inclusion Criteria- Septic Cases and Inflamed, Non-Septic Comparators: * Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease (all medium and large joints will be included: hip, knee, ankle, shoulder, subtalar, elbow, and wrist joints) * Patients with recent antibiotic exposure are eligible to participate but will be analyzed separately Inclusion Criteria- Normative Controls: * Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure) Exclusion Criteria- All Participants: * Family declines to participate/consent * Patients with a major joint trauma (such as a documented ligament tear or fracture) within the past 8 weeks are not eligible to have that joint aspirated, but could have another joint aspirated Exclusion Criteria- Normative Controls: * A history of recent infection (within the past 3 months) * Received antibiotics in the past 7 days
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What it tests

  • Synovial Alpha-defensin assay
  • Synovial Neutrophil elastase assay
  • Synovial lactate assay
  • Synovial C-reactive Protein (CRP)
  • Synovial Staphylococcus spp antigen panel
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Where

3 sites
Children's Healthcare of Atlanta
Atlanta, United States
Hospital for Special Surgery
New York, United States
Campbell Clinic
Collierville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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