Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Hospital for Special Surgery, New York
442 participants
Jun 28, 2016
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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)
Exclusion Criteria4
- 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
- A history of recent infection (within the past 3 months)
- Received antibiotics in the past 7 days
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Interventions
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
A blood test performed at the hospital.
A blood test performed at the hospital.
A blood test performed at the hospital.
A blood test performed at the hospital.
A blood test performed at the hospital.
Blood will be cultured at the hospital to see if any organisms grow.
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03704766