What this study is
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.
What's being tested
- Synovial Alpha-defensin assay
Intervention · DIAGNOSTIC TEST
- Synovial Neutrophil elastase assay
Intervention · DIAGNOSTIC TEST
- Synovial lactate assay
Intervention · DIAGNOSTIC TEST
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
- Synovial C-reactive Protein (CRP)
Intervention · DIAGNOSTIC TEST
- Synovial Staphylococcus spp antigen panel
Intervention · DIAGNOSTIC TEST
- Synovial Candida spp antigen panel
Intervention · DIAGNOSTIC TEST
- Synovial Enterococcus faecalis assay
Intervention · DIAGNOSTIC TEST
- Synovial bacterial culture by BacT/Alert
Intervention · DIAGNOSTIC TEST
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)
Intervention · DIAGNOSTIC TEST
- Synovial Gram Stain
Intervention · DIAGNOSTIC TEST
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
- Synovial Leukocyte Esterase Test Strips
Intervention · DIAGNOSTIC TEST
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
Intervention · DIAGNOSTIC TEST
In participants < 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
- Serum Cell count + differential (CBC)
Intervention · DIAGNOSTIC TEST
- Serum erythrocyte sedimentation rate (ESR)
Intervention · DIAGNOSTIC TEST
- Serum C-reactive Protein (CRP)
Intervention · DIAGNOSTIC TEST
- Serum D-dimer
Intervention · DIAGNOSTIC TEST
- Serum Procalcitonin
Intervention · DIAGNOSTIC TEST
- Blood Cultures
Intervention · DIAGNOSTIC TEST
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 )
Intervention · DIAGNOSTIC TEST
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
All of Synovial Alpha-defensin assay, Synovial Neutrophil elastase assay, Synovial C-reactive Protein (CRP), Synovial Staphylococcus spp antigen panel, Synovial Candida spp antigen panel, Synovial Enterococcus faecalis assay, Synovial Cell count + differential (CBC)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
All of Serum Cell count + differential (CBC), Serum erythrocyte sedimentation rate (ESR), Serum C-reactive Protein (CRP), Serum D-dimer, Serum Procalcitonin
A blood test performed at the hospital.
Study details
- Sponsor
- Hospital for Special Surgery, New York
- Conditions
- Joint Infection · Infection of Hip Joint (Disorder) · Infection of Shoulder Joint · Septic Arthritis
- Enrolling
- 442 people
- Starts
- 2016-06-28
- Est. completion
- 2026-05
- Design
- Double-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 17 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 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
You can't join if
- 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
Normative Controls
You may qualify if
- Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)
You can't join if
- A history of recent infection (within the past 3 months)
- Received antibiotics in the past 7 days
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
- Jack Goldberg, MS · Contact(678) 686-6864Jack.Goldberg@choa.org
- Tim Schrader, MD · Contact(404) 255-1933
RecruitingHospital for Special Surgery
New York, New York, United States
- Grace Wang, BA · Contact212-774-2121wangg@hss.edu
- Emily R Dodwell, MD, MPH · Contact212-606-1451
- Emily R Dodwell, MD, MPH · Principal investigator
- Joseph J Ruzbarsky, MD · Sub-investigator
- Roger F Widmann, MD · Sub-investigator
- Daniel W Green, MD · Sub-investigator
- John S Blanco, MD · Sub-investigator
- David M Scher, MD · Sub-investigator
- Shevaun M Doyle, MD · Sub-investigator
- Peter D Fabricant, MD, MPH · Sub-investigator
- Christine M Salvatore, MD · Sub-investigator
- Matthew Greenblatt, MD, PhD · Sub-investigator
- Huong Do, MS · Sub-investigator
RecruitingCampbell Clinic
Collierville, Tennessee, United States
- Jonathan Rowland · Contact(901) 287-5413Jonathan.Rowland@lebonheur.org
- Derek Kelly, MD · Contact(901) 759-3100
Not yet recruiting
Study team
Sponsor
Hospital for Special Surgery, New York
Study ID 2015-947
Principal investigator
Emily R Dodwell, MD, MPH
The Hospital for Special Surgery
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.