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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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)

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
New York
Hospital for Special Surgery
RECRUITING
New York
Tennessee
Campbell Clinic
NOT_YET_RECRUITING
Collierville
Contact Information
Primary
Grace Wang, BA
wangg@hss.edu
212-774-2121
Time Frame
Start Date: 2016-06-28
Estimated Completion Date: 2026-05
Participants
Target number of participants: 442
Treatments
Experimental: Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
Active_comparator: Normative Control
Patient undergoing procedure unrelated to infection/inflammation
Sponsors
Leads: Hospital for Special Surgery, New York
Collaborators: Pediatric Orthopaedic Society of North America, Children's Healthcare of Atlanta, CD Diagnostics, Campbell Clinic

This content was sourced from clinicaltrials.gov