RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-06-28
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03704766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Grace Wang, BA
CONTACT
212-774-2121
wangg@hss.edu

Principal Investigator

Emily R Dodwell, MD, MPH
PRINCIPAL_INVESTIGATOR
The Hospital for Special Surgery

Study Locations (Sites)

Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Campbell Clinic
Collierville, Tennessee, 38017
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Emily R Dodwell, MD, MPH, PRINCIPAL_INVESTIGATOR, The Hospital for Special Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-06-28
Study Completion Date2025-05

Study Record Updates

Study Start Date2016-06-28
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • synovial biomarkers
  • alpha-defensin
  • diagnostics
  • pediatric

Additional Relevant MeSH Terms

  • Joint Infection
  • Infection of Hip Joint (Disorder)
  • Infection of Shoulder Joint
  • Septic Arthritis