About this trial
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 study is to determine the sensitivity and specificity of several synovial biomarkers for diagnosing pediatric septic arthritis.
Eligibility criteria
Qualifiers
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
Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)
Disqualifiers
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
A history of recent infection (within the past 3 months)
Received antibiotics in the past 7 days
Trial design
Treatments tested in this trial
- Synovial Alpha-defensin assay
- Synovial Neutrophil elastase assay
- Synovial lactate assay
- Synovial C-reactive Protein (CRP)
- Synovial Staphylococcus spp antigen panel
- Synovial Candida spp antigen panel
- Synovial Enterococcus faecalis assay
- Synovial bacterial culture by BacT/Alert
- Synovial Cell count + differential (CBC)
- Synovial Gram Stain
- Synovial Leukocyte Esterase Test Strips
- Synovial PCR for Kingella kingae
- Serum Cell count + differential (CBC)
- Serum erythrocyte sedimentation rate (ESR)
- Serum C-reactive Protein (CRP)
- Serum D-dimer
- Serum Procalcitonin
- Blood Cultures
- Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
Treatment groups
Sponsors and collaborators
Hospital for Special Surgery, New York
Lead sponsor
Pediatric Orthopaedic Society of North America
Collaborator
Children's Healthcare of Atlanta
Collaborator
Campbell Clinic
Collaborator
CD Diagnostics
Collaborator