Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Recruiting
N/AInterventional Study
Joint InfectionInfection of Hip Joint (Disorder)Infection of Shoulder JointSeptic Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
Up to 17
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
442 (estimated)
Sponsor
Hospital for Special Surgery, New York · Other
Who this trial is looking for
This trial is looking for children with suspected joint infections to help find better ways to diagnose septic arthritis. Participants will have a special fluid test taken from their joints to check for infection or inflammation.
Are You a Good Fit for This Trial?
You may be able to join if
I have joint inflammation and need a fluid test from my joint.
I have had recent antibiotic treatment but can still join.
I am undergoing a procedure that is not related to an infection.
You may not be able to join if
My family has decided not to participate.
I have had a major injury to my joint in the past 8 weeks.
I have had an infection in the past 3 months.
I have taken antibiotics in the past 7 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 …
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.
Trial Locations
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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 anti…
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
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