Recruiting

Alpha-Defensin

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT03704766

Conditions

Joint Infection

Infection of Hip Joint (Disorder)

Infection of Shoulder Joint

Septic Arthritis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Synovial Alpha-defensin assay

Synovial Neutrophil elastase assay

Synovial lactate assay

Synovial C-reactive Protein (CRP)

Synovial Staphylococcus spp antigen panel

Study Details

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 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

Study ID

NCT03704766

Start date

Jun 28, 2016

Status verified date

Jun, 2024

Completion date

Jan, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

442 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Inflamed/Infected Joint

Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition

active comparator: Normative Control

Patient undergoing procedure unrelated to infection/inflammation

Interventions

Synovial Alpha-defensin assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial Neutrophil elastase assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial lactate assay

Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.

Synovial C-reactive Protein (CRP)

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial Staphylococcus spp antigen panel

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial Candida spp antigen panel

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial Enterococcus faecalis assay

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

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.

Synovial Cell count + differential (CBC)

One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.

Synovial Gram Stain

This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.

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.

Synovial PCR for Kingella kingae

In participants < 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.

Serum Cell count + differential (CBC)

A blood test performed at the hospital.

Serum erythrocyte sedimentation rate (ESR)

A blood test performed at the hospital.

Serum C-reactive Protein (CRP)

A blood test performed at the hospital.

Serum D-dimer

A blood test performed at the hospital.

Serum Procalcitonin

A blood test performed at the hospital.

Blood Cultures

Blood will be cultured at the hospital to see if any organisms grow.

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.

Primary outcome measure

  • Sensitivity and specificity of experimental tests [ Time Frame: Interim analysis at 2 years of study recruitment ]

Central Contacts and Locations

Central contacts

Grace Wang, BA

212-774-2121wangg@hss.edu

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Jack Goldberg, MS

(678) 686-6864Jack.Goldberg@choa.org

Tim Schrader, MD

(404) 255-1933

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Grace Wang, BA

212-774-2121wangg@hss.edu

Emily R Dodwell, MD, MPH

212-606-1451

Principal Investigator:

Emily R Dodwell, MD, MPH

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Jul 29, 2026

Last verified

Jun, 2024

Keywords

  • synovial biomarkers
  • alpha-defensin
  • diagnostics
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-07-29.