Actively Recruiting
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Led by Hospital for Special Surgery, New York · Updated on 2025-06-22
442
Participants Needed
3
Research Sites
513 weeks
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
P
Pediatric Orthopaedic Society of North America
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease in medium and large joints including hip, knee, ankle, shoulder, subtalar, elbow, and wrist
- Patients with recent antibiotic exposure are eligible but will be analyzed separately
- Patients undergoing a procedure unrelated to infection such as arthroscopy or bony or soft tissue procedure (normative controls)
You will not qualify if you...
- Family declines to participate or provide consent
- Patients with major joint trauma like ligament tear or fracture in the past 8 weeks are not eligible for joint aspiration of that joint
- Normative controls with a history of infection in the past 3 months are excluded
- Normative controls who received antibiotics in the past 7 days are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
2
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
3
Campbell Clinic
Collierville, Tennessee, United States, 38017
Not Yet Recruiting
Research Team
G
Grace Wang, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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