Diagnostic Tests for Pediatric Septic Arthritis
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hospital for Special Surgery, New York
Disqualifiers: Major joint trauma, Recent infection, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, patients with recent antibiotic exposure can participate, but they will be analyzed separately.
What data supports the effectiveness of the treatment Alpha-defensin assay, Alpha-defensin test, Alpha-defensin lateral flow assay, Synovasure for diagnosing pediatric septic arthritis?
The Alpha-defensin lateral flow test, known as Synovasure, has been shown to quickly and accurately diagnose infections in joint fluid, particularly in cases of prosthetic joint infections, even when antibiotics are present. While its effectiveness for pediatric septic arthritis specifically isn't directly studied, its success in similar joint infection scenarios suggests it could be a useful diagnostic tool.
12345Is the Alpha-defensin test safe for humans?
The research articles focus on the accuracy and diagnostic value of the Alpha-defensin test for detecting joint infections, but they do not provide specific information about its safety in humans.
12567How does the alpha-defensin test differ from other treatments for pediatric septic arthritis?
The alpha-defensin test is unique because it provides rapid results within minutes for diagnosing infections in joint fluid, even when antibiotics are already being used, unlike traditional methods that can take days and may miss certain infections.
12346Eligibility Criteria
This trial is for children with joint inflammation who are undergoing procedures to assess for infection or inflammatory diseases. It includes those with recent antibiotic use, covering various joints like the hip, knee, and shoulder. Children not being assessed for infection-related procedures are excluded.Inclusion Criteria
I am having a surgery not related to an infection.
I have had fluid taken from my joints to check for infection or inflammation.
You can participate in the study if you have taken antibiotics recently, but your data will be analyzed separately.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Standard of Care Visit
Participants undergo joint aspiration or arthroscopy for diagnostic testing
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after diagnostic procedures
4 weeks
Participant Groups
The study tests several synovial biomarkers' ability to diagnose pediatric septic arthritis quickly and accurately. This includes assays for alpha-defensin, neutrophil elastase, bacterial cultures, antigen panels, lactate levels among others compared to standard blood tests.
2Treatment groups
Experimental Treatment
Active Control
Group I: Inflamed/Infected JointExperimental Treatment19 Interventions
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
Group II: Normative ControlActive Control19 Interventions
Patient undergoing procedure unrelated to infection/inflammation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Healthcare of AtlantaAtlanta, GA
Hospital for Special SurgeryNew York, NY
Campbell ClinicCollierville, TN
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Who Is Running the Clinical Trial?
Hospital for Special Surgery, New YorkLead Sponsor
Campbell ClinicCollaborator
Pediatric Orthopaedic Society of North AmericaCollaborator
Children's Healthcare of AtlantaCollaborator
CD DiagnosticsIndustry Sponsor
References
Does the alpha-defensin lateral flow test conserve its diagnostic properties in a larger population of chronic complex periprosthetic infections? Enlargement to 112 tests, from 42 tests in a preliminary study, in a reference center. [2021]Diagnosis of periprosthetic infection (PPI) is crucial for management of bone and joint infection. The preoperative gold-standard is joint aspiration, providing results after 2-14 days' culture, with non-negligible false negative rates due to the fragility of certain micro-organisms and/or prior antibiotic treatment. The Synovasure™ alpha-defensin lateral flow test (Zimmer, Warsaw, IN, USA) contributes within minutes to joint fluid diagnosis of almost all infectious agents, including in case of concomitant antibiotic therapy. Validity remains controversial, notably in complex microbiological situations: multi-operated patients, diagnostic doubt despite iterative sterile culture, long-course antibiotic therapy. We extended a prospective study reported in 2018, to determine whether the test maintained diagnostic value in a larger population, assessing 1) negative (NPV) and positive (PPV) predictive value, and 2) sensitivity and specificity.
Does the Alpha-defensin Immunoassay or the Lateral Flow Test Have Better Diagnostic Value for Periprosthetic Joint Infection? A Meta-analysis. [2020]Measuring alpha-defensin concentrations in synovial fluid may help to diagnose periprosthetic joint infection (PJI). There are two commercially available methods for measuring alpha-defensin in synovial fluid: the enzyme-linked immunosorbent assay-based Synovasure® alpha-defensin immunoassay, which gives a numeric readout within 24 hours, and the Synovasure lateral flow test, which gives a binary readout within 20 minutes. There is no compilation of the existing literature to support the use of one of these two tests over the other.
Intraoperative Diagnosis of Periprosthetic Joint Infection Using a Novel Alpha-Defensin Lateral Flow Assay. [2022]The present study investigates the novel Synovasure periprosthetic joint infection (PJI) lateral flow test device for detection of alpha-defensin and attempts to determine its diagnostic accuracy for the intraoperative diagnosis of PJI and compares it to frozen section.
The Alpha-Defensin Prosthetic Joint Infection Test Has Poor Validity for Native Knee Joint Infection. [2021]The alpha-defensin test known as Synovaure has been very effective in diagnosis of prosthetic joint infections (PJIs). Being able to easily and accurately differentiate septic and inflammatory arthropathies in native joints would improve diagnostic workup and management. We tested the ability of an alpha-defensin test to distinguish septic from inflammatory or crystalline arthropathy in the native knee.
The Accuracy of the Alpha Defensin Lateral Flow Device for Diagnosis of Periprosthetic Joint Infection: Comparison with a Gold Standard. [2019]Alpha defensin is a new biomarker that has been shown to have a very high accuracy to rule out periprosthetic joint infection. Recently, a new rapid lateral flow version of the alpha defensin test was developed and introduced to detect high levels of alpha defensin in synovial fluid quickly and with ease. We conducted a single-center prospective clinical study to compare the results of the Synovasure Alpha Defensin Test with those of the Musculoskeletal Infection Society (MSIS) criteria, which are considered to be the gold standard for diagnosing periprosthetic joint infection.
High performance of α-defensin lateral flow assay (Synovasure) in the diagnosis of chronic knee prosthetic infections. [2018]This prospective study was undertaken to evaluate the diagnostic accuracy of the Synovasure™ α-defensin lateral flow assay to detect or exclude infection and to compare it to the sensitivity and specificity of other diagnostic criteria according to the International Consensus Group on Periprosthetic Joint Infection (PJI).
Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians. [2022]This study aimed to test the accuracy of the Synovasure®, α-defensin lateral flow test kit, in diagnosing periprosthetic joint infections (PJIs) in a predominantly Asian population and to evaluate whether other patient or disease factors may affect its results.