Hospital for Special Surgery, New York
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.
Joint Infection
Infection of Hip Joint (Disorder)
Infection of Shoulder Joint
Septic Arthritis
Synovial Alpha-defensin assay
Synovial Neutrophil elastase assay
Synovial lactate assay
Synovial C-reactive Protein (CRP)
Synovial Staphylococcus spp antigen panel
Synovial Candida spp antigen panel
Synovial Enterococcus faecalis assay
Synovial bacterial culture by BacT/Alert
Synovial Cell count + differential (CBC)
Synovial Gram Stain
Synovial Leukocyte Esterase Test Strips
Synovial PCR for Kingella kingae
Serum Cell count + differential (CBC)
Serum erythrocyte sedimentation rate (ESR)
Serum C-reactive Protein (CRP)
Serum D-dimer
Serum Procalcitonin
Blood Cultures
Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
NA
The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infection typically undergo joint aspiration so that tests can be performed to help diagnose joint infection, including gram stain, cell count, and culture. Patients under 18 years old that are undergoing sampling of their joint fluid due to suspicion of infection or inflammation will be enrolled in this multi-center trial. Joint fluid will also be sampled from normative controls made up of patients who are undergoing an unrelated procedure without inflammation or infection. Joint fluid from patients with suspected inflammation/infection and from normative controls will be analysed for presence of alpha-defensin, leukocyte esterase, neutrophil elastase, synovial C-reactive protein, and synovial lactate. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies. Additionally a Staphylococcus spp antigen panel, Candida spp antigen panel, Enterococcus faecalis assay, BACTAlert culture, cell count plus differential, gram stain, and aerobic, anaerobic, and fungal cultures will be done using synovial fluid. A synovial fluid PCR for Kingella kingae will be performed if the patient is under eight years of age. Blood tests will include cell count and differential, erythrocyte sedimentation rate, C-reactive protein, procalcitonin, and D-dimer, as well as relevant inflammatory or rheumatologic marker tests. Results from these tests will be compared to joint fluid culture which the gold standard for diagnosing bacterial infection. The study includes 1 visit per patient, the standard of care visit in which the patient would be undergoing joint aspiration or arthroscopy. Once data has been collected, the sensitivity and specificity will be determined for these experimental tests both individually and in combination.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 442 participants |
| Masking : | DOUBLE |
| Masking Description : | For patients with inflamed joints, the medical team will be blind to the results of the alpha-defensin assay and other experimental tests for a period of 2 weeks, after which results may be divulged to the clinical team at their request. As such, the results will not influence the physician/surgeons' decision for acute treatment of the patient, as the decision to treat suspected septic arthritis is typically made within 24 hours, and the final diagnosis is made within 2 weeks (pending culture results). As the testing of the leukocyte esterase strips will occur in the operating room, the surgeon will not be blinded to these results. A blinded team member will read the pictures of all of the leukocyte test strip results at once, after they have all been collected. The patient will be made aware of results at the physician/surgeon's discretion. For normative controls, the results of experimental testing will not be divulged to the clinical team or to the patient. |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis |
| Actual Study Start Date : | 2016-06-28 |
| Estimated Primary Completion Date : | 2026-05 |
| Estimated Study Completion Date : | 2026-05 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | to 17 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
RECRUITING
Hospital for Special Surgery
New York, New York, United States, 10021
NOT YET RECRUITING
Campbell Clinic
Collierville, Tennessee, United States, 38017