Status:

RECRUITING

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

Lead Sponsor:

Hospital for Special Surgery, New York

Collaborating Sponsors:

Pediatric Orthopaedic Society of North America

Children's Healthcare of Atlanta

Conditions:

Joint Infection

Infection of Hip Joint (Disorder)

Eligibility:

All Genders

Up to 17 years

Phase:

NA

Brief 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...

Detailed Description

The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infectio...

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 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

Key Trial Info

Start Date :

June 28 2016

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

442 Patients enrolled

Trial Details

Trial ID

NCT03704766

Start Date

June 28 2016

End Date

May 1 2026

Last Update

June 22 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

2

Hospital for Special Surgery

New York, New York, United States, 10021

3

Campbell Clinic

Collierville, Tennessee, United States, 38017

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