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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorHospital for Special Surgery, New York

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

442 Participants
are divided into 2 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