Diagnostic Tests for Pediatric Septic Arthritis

Recruiting at 2 trial locations

Overseen By Grace Wang, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Major joint trauma, Recent infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

442 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the diagnosis of septic arthritis (a joint infection) in children. It will evaluate the effectiveness of an alpha-defensin assay (a type of lab test) in identifying infections compared to current methods. The study will include children with joint inflammation or those undergoing unrelated procedures. Ideal participants are children needing joint tests for possible infections or conditions like arthritis, who have not recently experienced a major joint injury.

As an unphased trial, this study allows participants to contribute to important research that could enhance diagnostic methods for future patients.

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 prior data suggests that the alpha-defensin assay is safe for diagnosing pediatric septic arthritis?

Research has shown that the alpha-defensin test effectively detects joint infections. Studies have demonstrated its high accuracy, correctly identifying infections and rarely producing false results.

Importantly, the alpha-defensin test is neither a drug nor a procedure that directly affects the body. It does not involve taking medicine or undergoing surgery. No reports of side effects from the test itself exist. The test helps doctors determine the presence of an infection by analyzing joint fluid already collected for other purposes.

Overall, evidence suggests that the alpha-defensin test is a safe and reliable method for diagnosing joint infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the alpha-defensin assay for diagnosing pediatric septic arthritis because it offers a faster and potentially more accurate way to identify infections in joints. Unlike standard methods, such as blood tests and imaging, which can take time to analyze and might not always clearly indicate an infection, the alpha-defensin assay quickly detects specific proteins associated with infection. This rapid detection could lead to quicker treatment decisions, reducing the risk of joint damage and improving outcomes for young patients.

What evidence suggests that the alpha-defensin assay is effective for diagnosing pediatric septic arthritis?

Research has shown that the alpha-defensin test, which participants in this trial may undergo, effectively detects joint infections. It accurately identifies the presence or absence of an infection. Studies indicate that this test can correctly diagnose septic arthritis, a serious joint infection requiring prompt treatment. The test is particularly beneficial because it provides results faster than traditional methods. This rapid response is crucial for doctors to make timely decisions about surgery to prevent joint damage. Previous research demonstrated that alpha-defensin can effectively distinguish between septic arthritis and other types of joint inflammation in children. ^{1 2 3 6 7}

Who Is on the Research Team?

Emily R Dodwell, MD, MPH

Principal Investigator

The Hospital for Special Surgery

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Alpha-defensin assay

Trial Overview 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.

How Is the Trial Designed?

Group I: Inflamed/Infected Joint Experimental Treatment 19 Interventions

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

Group II: Normative Control Active Control 19 Interventions

Patient undergoing procedure unrelated to infection/inflammation

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Campbell Clinic

Collaborator

Trials

15

Recruited

2,100+

Pediatric Orthopaedic Society of North America

Collaborator

Trials

8

Recruited

1,500+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

CD Diagnostics

Industry Sponsor

Trials

2

Recruited

3,400+

Published Research Related to This Trial

The alpha-defensin test (Synovasure) demonstrated 100% specificity for diagnosing septic arthritis in native knee joint fluid, but it had a high false-positive rate of 28%, particularly in patients with crystalline arthropathy.

This high false-positive rate suggests that while the test is effective for prosthetic joint infections, caution is needed when using it for native knee joint diagnoses, as it may lead to misdiagnosis in cases involving crystals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Alpha-Defensin Prosthetic Joint Infection Test Has Poor Validity for Native Knee Joint Infection. Cooper, KB., Siegel, ER., Stambough, JB., et al.[2021]

The Synovasure™ alpha-defensin lateral flow test demonstrated a high negative predictive value (NPV) of 98.8% in diagnosing periprosthetic infections (PPI) in a complex patient population of 106 individuals, indicating it is very effective at ruling out infections.

With a sensitivity of 95.5% and specificity of 91%, Synovasure™ provides rapid results compared to traditional joint aspiration methods, making it a reliable diagnostic tool, especially in cases where prior antibiotic treatment complicates diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. de Saint Vincent, B., Martinot, P., Pascal, A., et al.[2021]

The Synovasure Alpha Defensin Test demonstrated a high accuracy for diagnosing periprosthetic joint infections, with a sensitivity of 92.1% and specificity of 100% based on a study of 191 patients who underwent joint aspirations after hip or knee surgeries.

This rapid test allows for early detection of infections, enabling timely treatment, although it does not identify the specific infectious pathogen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accuracy of the Alpha Defensin Lateral Flow Device for Diagnosis of Periprosthetic Joint Infection: Comparison with a Gold Standard. Gehrke, T., Lausmann, C., Citak, M., et al.[2019]

The Synovasure lateral flow test for detecting periprosthetic joint infection (PJI) showed an overall accuracy of 85% in a study of 40 patients undergoing revision surgery, making it a reliable tool for intraoperative diagnosis.

Compared to the traditional frozen section method, the Synovasure test had a higher negative predictive value (87% vs. 58% sensitivity), indicating it is effective in confirming the absence of PJI, although its performance is not as strong as laboratory measurements of alpha-defensin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Diagnosis of Periprosthetic Joint Infection Using a Novel Alpha-Defensin Lateral Flow Assay. Kasparek, MF., Kasparek, M., Boettner, F., et al.[2022]

The Synovasure™ α-defensin lateral flow assay demonstrated high diagnostic accuracy for detecting periprosthetic joint infection (PJI), with a sensitivity of 87.5% and specificity of 97.1%, making it more effective than traditional tests like cultures and synovial cell counts.

With an area under the curve (AUC) of 0.92, the α-defensin test outperformed all other diagnostic criteria for PJI, suggesting it could be a valuable tool in clinical practice for timely and accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High performance of α-defensin lateral flow assay (Synovasure) in the diagnosis of chronic knee prosthetic infections. Balato, G., Franceschini, V., Ascione, T., et al.[2018]

The Synovasure® α-defensin lateral flow test demonstrated a sensitivity of 73.7% and specificity of 92.2% for diagnosing periprosthetic joint infections (PJIs) in a study of 61 Asian patients, indicating it is a reliable diagnostic tool, though slightly less effective than in predominantly Caucasian populations.

Factors such as diabetes, systemic inflammatory joint disease, and prior antibiotic usage did not significantly affect the test results, suggesting that the α-defensin test's accuracy is robust across various patient conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians. Ding, BT., Tan, KG., Kau, CY., et al.[2022]

The alpha-defensin immunoassay is more effective than the lateral flow test for diagnosing periprosthetic joint infection (PJI), showing a sensitivity of 96% compared to 71% for the lateral flow test, based on a review of studies involving 601 joints.

While both tests have similar specificity, the immunoassay provides a more accurate diagnosis, making it a better choice for confirming PJI, whereas the lateral flow test, despite its lower sensitivity, can be useful for quickly ruling in infection during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Alpha-defensin Immunoassay or the Lateral Flow Test Have Better Diagnostic Value for Periprosthetic Joint Infection? A Meta-analysis. Eriksson, HK., Nordström, J., Gabrysch, K., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40455616/

The alpha-defensin can rule out septic arthritis in pediatric ... This study tests the hypothesis that the alpha-defensin can diagnose pediatric septic arthritis and differ nonseptic arthritis (NSA) in native joints.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03704766

Alpha-Defensin and Synovial Proteins to Improve ... 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 ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT03704766

Alpha-Defensin and Synovial Proteins to Improve Detection of ... 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 ...

4. researchgate.net researchgate.net/publication/392365409_The_alpha-defensin_can_rule_out_septic_arthritis_in_pediatric_cases_a_first_case_series_study

The alpha-defensin can rule out septic arthritis in pediatric ... This study tests the hypothesis that the alpha-defensin can diagnose pediatric septic arthritis and differ nonseptic arthritis (NSA) in native ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540321002606

The Alpha-Defensin Prosthetic Joint Infection Test Has ... The results of this study indicate that the Synovasure PJI test has 100% sensitivity but a 28% false-positive rate for detection of septic arthritis in native ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/277720

Alpha-Defensin and Synovial Proteins to Improve ... The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this study is to ...

7. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/diagnostics/synovasure-alpha-defensin-lateral-flow-test.html

Synovasure® Alpha Defensin Lateral Flow Test The Synovasure Alpha Defensin Test is designed as an aid for the diagnosis of Periprosthetic Joint Infection. Intended for healthcare professionals.