Actively Recruiting

Phase Not Applicable
Age: 0 - 17Years
All Genders
ID03704766

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

Led by Hospital for Special Surgery, New York · Updated on 2025-06-22

442

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hospital for Special Surgery, New York

Lead Sponsor

P

Pediatric Orthopaedic Society of North America

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how to better identify septic arthritis, a serious joint infection in children, by testing several proteins in joint fluid. Diagnosing septic arthritis early is crucial because it requires surgery to prevent permanent joint damage. The current gold standard diagnosis is a positive joint fluid culture, which takes days, so quicker tests like the alpha-defensin assay are being evaluated for their accuracy in detecting infection in children under 18. This study compares joint fluid from children suspected of having joint infections or inflammation with samples from children undergoing unrelated procedures without infection. Various tests will be performed on the joint fluid, including alpha-defensin, leukocyte esterase, neutrophil elastase, C-reactive protein, lactate, and several bacterial and fungal antigen panels. Blood tests will also be done to measure markers of infection and inflammation. Results from these experimental tests will be compared to the standard joint fluid culture. Participants will have one study visit during their standard care procedure involving joint fluid sampling. Researchers will analyze the sensitivity and specificity of these tests to see how well they detect bacterial infection. The study will include children up to 17 years old and will provide important information to help diagnose septic arthritis faster and more accurately in pediatric patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease in medium and large joints (hip, knee, ankle, shoulder, subtalar, elbow, wrist)
  • Patients with recent antibiotic exposure are eligible but analyzed separately
  • Patients undergoing a procedure unrelated to infection or inflammation (such as arthroscopy or other bony or soft tissue procedures)
Not Eligible

You will not qualify if you...

  • Family declines to participate or consent
  • Patients with major joint trauma (e.g., ligament tear or fracture) within past 8 weeks are not eligible for aspiration of that joint
  • Normative controls with recent infection within past 3 months
  • Normative controls who received antibiotics in past 7 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo joint fluid sampling and blood tests to diagnose bacterial joint infections or inflammation. Various synovial fluid and blood assays are performed, including alpha-defensin, leukocyte esterase, neutrophil elastase, cultures, PCR for Kingella kingae (if under 8 years old), and other inflammatory markers.

1 standard of care visit (joint aspiration or arthroscopy)

Trial Site Locations

Total: 3 locations

1

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

Actively Recruiting

2

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

3

Campbell Clinic

Collierville, Tennessee, United States, 38017

Not Yet Recruiting

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Research Team

G

Grace Wang, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Leukocyte esterase analysis in the diagnosis of joint infection: can we make a diagnosis using a simple urine dipstick?

Otis C Colvin, Mark J Kransdorf, Catherine C Roberts...

https://pubmed.ncbi.nlm.nih.gov/25626524

Gram and acridine orange staining for diagnosis of septic arthritis in different patient populations.

Gregory Cunningham, Khalid Seghrouchni, Etienne Ruffieux...

https://pubmed.ncbi.nlm.nih.gov/24496757

Combined measurement of synovial fluid α-Defensin and C-reactive protein levels: highly accurate for diagnosing periprosthetic joint infection.

Carl Deirmengian, Keith Kardos, Patrick Kilmartin...

https://pubmed.ncbi.nlm.nih.gov/25187582

The impact of the current epidemiology of pediatric musculoskeletal infection on evaluation and treatment guidelines.

Omar A Gafur, Lawson A B Copley, S Tyler Hollmig...

https://pubmed.ncbi.nlm.nih.gov/18812907