Status:
RECRUITING
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Pediatric Orthopaedic Society of North America
Children's Healthcare of Atlanta
Conditions:
Joint Infection
Infection of Hip Joint (Disorder)
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
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...
Detailed Description
The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infectio...
Eligibility Criteria
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
Key Trial Info
Start Date :
June 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT03704766
Start Date
June 28 2016
End Date
May 1 2026
Last Update
June 22 2025
Active Locations (3)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
2
Hospital for Special Surgery
New York, New York, United States, 10021
3
Campbell Clinic
Collierville, Tennessee, United States, 38017