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

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 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.

Conditions

• Joint Infection
• Infection of Hip Joint (Disorder)
• Infection of Shoulder Joint
• 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.

Sponsors & Collaborators

• Pediatric Orthopaedic Society of North America

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• Campbell Clinic

  collaborator OTHER

• CD Diagnostics

  collaborator INDUSTRY

• Hospital for Special Surgery, New York

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-28

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• United States

Study Locations