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

Recruiting

Who can join

Up to age 17 · All sexes

Full 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

About the study

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.

What is being tested

Synovial Alpha-defensin assay (diagnostic test)
Synovial Neutrophil elastase assay (diagnostic test)
Synovial lactate assay (diagnostic test)
Synovial C-reactive Protein (CRP) (diagnostic test)
Synovial Staphylococcus spp antigen panel (diagnostic test)
Synovial Candida spp antigen panel (diagnostic test)

Sponsor: Hospital for Special Surgery, New York · Participants: 442 · Started: Jun 28, 2016

Contact the study team

Grace Wang, BA · Phone: 212-774-2121

Official record on ClinicalTrials.gov — NCT03704766

Locations in the U.S.

Georgia	Children's Healthcare of Atlanta, Atlanta
New York	Hospital for Special Surgery, New York
Tennessee	Campbell Clinic, Collierville (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.