Evidence-based diagnostics: adult septic arthritis.
Christopher R Carpenter, Jeremiah D Schuur, Worth W Everett...
https://pubmed.ncbi.nlm.nih.gov/21843213/Actively Recruiting
Led by Hospital for Special Surgery, New York · Updated on 2026-07-29
442
Participants Needed
3
Research Sites
8 weeks
Total Duration
Differentiating septic arthritis from other causes of joint inflammation in children is critical because septic arthritis requires prompt surgical treatment to prevent lasting joint damage. This study aims to evaluate the accuracy of several synovial fluid biomarkers, including alpha-defensin and others, in diagnosing pediatric septic arthritis. The research focuses on improving rapid diagnosis since current culture methods take several days, causing delays in treatment decisions. Participants include children under 18 years old undergoing joint fluid sampling due to suspected infection or inflammation, as well as normative controls undergoing unrelated procedures without infection. Various synovial fluid tests will be performed, such as alpha-defensin assay, leukocyte esterase test, neutrophil elastase, synovial C-reactive protein, and culture tests. Blood tests and PCR for Kingella kingae in children under 8 will also be conducted. These tests will be compared to joint fluid culture, the current gold standard. Participants take part in one study visit during which joint aspiration or arthroscopy is performed as part of their usual care. Researchers will analyze the synovial fluid and blood samples for these biomarkers and compare results to culture outcomes. The primary outcome is the sensitivity and specificity of these experimental tests for diagnosing infection. Data from this single visit will help determine if these tests can improve early detection of pediatric septic arthritis.
CONDITIONS
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
G
Grace Wang, BA
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Hospital for Special Surgery, New York
Lead Sponsor
Pediatric Orthopaedic Society of North America
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Panel of investigational synovial fluid protein and biomarker assays | Current synovial fluid and serum diagnostic pathway for pediatric septic arthritis |
|---|---|---|
| What it is | A panel of synovial fluid tests measuring proteins and biomarkers including alpha-defensin, neutrophil elastase, lactate, C-reactive protein, and pathogen-specific antigens or DNA. These assays are studied for their ability to improve detection of septic arthritis in children and adolescents. | The current clinical pathway involves synovial fluid Gram stain, cell count with differential, culture for bacterial growth, and serum inflammatory tests such as CRP and ESR, combined with clinical assessment of the affected joint. |
| Role in trial | Tested as investigational approaches to improve diagnostic accuracy for septic arthritis, with both septic and inflamed non-septic cases compared to normative controls. | Serves as the established reference pathway against which the trial's novel tests are evaluated; applied routinely for suspected pediatric joint infection. |
| Primary use | To evaluate whether new synovial protein and biomarker assays can more accurately detect infection in joints of children and adolescents compared to established methods. | Used to diagnose septic arthritis and distinguish it from other joint conditions using recognized laboratory and clinical criteria. |
| How it is performed | Synovial fluid samples are obtained from joints under suspicion, processed via assay panels in an external laboratory to measure protein and biomarker concentrations. | Joint aspiration followed by immediate Gram stain and cell count, culture for organisms, serum testing for inflammatory markers, and clinical examination. |
| Evidence status | Emerging evidence suggests synovial alpha-defensin and combined protein assays offer improved sensitivity and specificity over conventional methods for joint infection diagnosis, but pediatric data remain limited and results from this study are not yet established. | Current pathway has recognized sensitivity and specificity, but Gram stain and culture may miss certain infections; synovial cell count and serum markers aid diagnosis but have limitations in accuracy. |
| Important limitations | Clinical validation of synovial protein biomarkers in children is limited, and assay results may be influenced by prior antibiotic exposure or underlying inflammatory conditions. Real-world performance is not yet confirmed for all pediatric joint infection scenarios. | Gram stain and culture tests may be negative in true infection, especially with prior antibiotic exposure. Synovial cell count and serum markers can be non-specific, leading to diagnostic uncertainty. Performance may vary across age groups and joint sites. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants undergo joint fluid aspiration or arthroscopy as part of routine care. Samples of joint fluid and blood are collected to test for various proteins and infection markers.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/27503025/Hospital for Special Surgery, New York
Lead Sponsor
Pediatric Orthopaedic Society of North America
Collaborating Sponsor