NCT03704766 · Hospital for Special Surgery, New York
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Synovial Alpha-defensin assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial Neutrophil elastase assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial lactate assay
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
DIAGNOSTIC_TEST
Synovial C-reactive Protein (CRP)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial Staphylococcus spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial Candida spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial Enterococcus faecalis assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial bacterial culture by BacT/Alert
The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
DIAGNOSTIC_TEST
Synovial Cell count + differential (CBC)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
DIAGNOSTIC_TEST
Synovial Gram Stain
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
DIAGNOSTIC_TEST
Synovial Leukocyte Esterase Test Strips
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.
DIAGNOSTIC_TEST
Synovial PCR for Kingella kingae
In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
DIAGNOSTIC_TEST
Serum Cell count + differential (CBC)
A blood test performed at the hospital.
DIAGNOSTIC_TEST
Serum erythrocyte sedimentation rate (ESR)
A blood test performed at the hospital.
DIAGNOSTIC_TEST
Serum C-reactive Protein (CRP)
A blood test performed at the hospital.
DIAGNOSTIC_TEST
Serum D-dimer
A blood test performed at the hospital.
DIAGNOSTIC_TEST
Serum Procalcitonin
A blood test performed at the hospital.
DIAGNOSTIC_TEST
Blood Cultures
Blood will be cultured at the hospital to see if any organisms grow.
DIAGNOSTIC_TEST
Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
Primary outcome measures
Sensitivity and specificity of experimental tests
Time frame: Interim analysis at 2 years of study recruitment
Sensitivity and specificity have been selected as these are standard outcome tests when determining the utility of a diagnostic test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
- New York, New York
- Collierville, Tennessee
Collaborators
Pediatric Orthopaedic Society of North America, Children's Healthcare of Atlanta, Campbell Clinic, CD Diagnostics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations