NCT03704766 Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
| NCT ID | NCT03704766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 442 participants |
| Start Date | 2016-06-28 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 442 participants in total. It began in 2016-06-28 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Emily R Dodwell, MD, MPH
PRINCIPAL INVESTIGATOR
The Hospital for Special Surgery
Frequently Asked Questions
Who can join the NCT03704766 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03704766 currently recruiting?
Yes, NCT03704766 is actively recruiting participants. Contact the research team at wangg@hss.edu for enrollment information.
Where is the NCT03704766 trial being conducted?
This trial is being conducted at Atlanta, United States, New York, United States, Collierville, United States.
Who is sponsoring the NCT03704766 clinical trial?
NCT03704766 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Emily R Dodwell, MD, MPH at The Hospital for Special Surgery. The trial plans to enroll 442 participants.