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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 5 6 7}

How 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. ^{1 2 3 4 6}

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.

Research Team

Emily R Dodwell, MD, MPH

Principal Investigator

The Hospital for Special Surgery

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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™ 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]

References

1. France 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. [2021]

2. United States 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Diagnosis of Periprosthetic Joint Infection Using a Novel Alpha-Defensin Lateral Flow Assay. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Alpha-Defensin Prosthetic Joint Infection Test Has Poor Validity for Native Knee Joint Infection. [2021]

5. United States 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. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

High performance of α-defensin lateral flow assay (Synovasure) in the diagnosis of chronic knee prosthetic infections. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Accuracy of the α-defensin lateral flow assay for diagnosing periprosthetic joint infection in Asians. [2022]