[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100339842":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":106,"centralContacts":111,"locations":117,"responsibleParty":194,"collaborators":196,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":43,"eligibilityCriteria":209,"healthyVolunteers":206,"sex":210,"minAge":43,"maxAge":211,"enrollmentInfo":212,"targetDuration":43,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":120,"whyStopped":43,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",[8,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Inflamed\u002FInfected Joint","EXPERIMENTAL","Patients undergoing joint aspiration\u002Fdebridement due to suspicion of septic joint or rheumatologic\u002Finflammatory condition",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31],"Diagnostic Test: Synovial Alpha-defensin assay","Diagnostic Test: Synovial Neutrophil elastase assay","Diagnostic Test: Synovial lactate assay","Diagnostic Test: Synovial C-reactive Protein (CRP)","Diagnostic Test: Synovial Staphylococcus spp antigen panel","Diagnostic Test: Synovial Candida spp antigen panel","Diagnostic Test: Synovial Enterococcus faecalis assay","Diagnostic Test: Synovial bacterial culture by BacT\u002FAlert","Diagnostic Test: Synovial Cell count + differential (CBC)","Diagnostic Test: Synovial Gram Stain","Diagnostic Test: Synovial Leukocyte Esterase Test Strips","Diagnostic Test: Synovial PCR for Kingella kingae","Diagnostic Test: Serum Cell count + differential (CBC)","Diagnostic Test: Serum erythrocyte sedimentation rate (ESR)","Diagnostic Test: Serum C-reactive Protein (CRP)","Diagnostic Test: Serum D-dimer","Diagnostic Test: Serum Procalcitonin","Diagnostic Test: Blood Cultures","Diagnostic Test: Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory\u002F rheumatologic markers )",{"label":33,"type":34,"description":35,"interventionNames":36},"Normative Control","ACTIVE_COMPARATOR","Patient undergoing procedure unrelated to infection\u002Finflammation",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31],[38,44,47,51,54,57,60,63,67,70,74,78,82,86,89,92,95,98,102],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DIAGNOSTIC_TEST","Synovial Alpha-defensin assay","One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.",[9,33],null,{"type":39,"name":45,"description":41,"armGroupLabels":46,"otherNames":43},"Synovial Neutrophil elastase assay",[9,33],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":43},"Synovial lactate assay","Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.",[9,33],{"type":39,"name":52,"description":41,"armGroupLabels":53,"otherNames":43},"Synovial C-reactive Protein (CRP)",[9,33],{"type":39,"name":55,"description":41,"armGroupLabels":56,"otherNames":43},"Synovial Staphylococcus spp antigen panel",[9,33],{"type":39,"name":58,"description":41,"armGroupLabels":59,"otherNames":43},"Synovial Candida spp antigen panel",[9,33],{"type":39,"name":61,"description":41,"armGroupLabels":62,"otherNames":43},"Synovial Enterococcus faecalis assay",[9,33],{"type":39,"name":64,"description":65,"armGroupLabels":66,"otherNames":43},"Synovial bacterial culture by BacT\u002FAlert","The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.",[9,33],{"type":39,"name":68,"description":41,"armGroupLabels":69,"otherNames":43},"Synovial Cell count + differential (CBC)",[9,33],{"type":39,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"Synovial Gram Stain","This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.",[9,33],{"type":39,"name":75,"description":76,"armGroupLabels":77,"otherNames":43},"Synovial Leukocyte Esterase Test Strips","These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.",[9,33],{"type":39,"name":79,"description":80,"armGroupLabels":81,"otherNames":43},"Synovial PCR for Kingella kingae","In participants \\\u003C 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.",[9,33],{"type":39,"name":83,"description":84,"armGroupLabels":85,"otherNames":43},"Serum Cell count + differential (CBC)","A blood test performed at the hospital.",[9,33],{"type":39,"name":87,"description":84,"armGroupLabels":88,"otherNames":43},"Serum erythrocyte sedimentation rate (ESR)",[9,33],{"type":39,"name":90,"description":84,"armGroupLabels":91,"otherNames":43},"Serum C-reactive Protein (CRP)",[9,33],{"type":39,"name":93,"description":84,"armGroupLabels":94,"otherNames":43},"Serum D-dimer",[9,33],{"type":39,"name":96,"description":84,"armGroupLabels":97,"otherNames":43},"Serum Procalcitonin",[9,33],{"type":39,"name":99,"description":100,"armGroupLabels":101,"otherNames":43},"Blood Cultures","Blood will be cultured at the hospital to see if any organisms grow.",[9,33],{"type":39,"name":103,"description":104,"armGroupLabels":105,"otherNames":43},"Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory\u002F rheumatologic markers )","In patients with suspected inflammation\u002Finfection, there are other blood tests which may be standard of care and used for diagnosis.",[9,33],[107],{"name":108,"affiliation":109,"role":110},"Emily R Dodwell, MD, MPH","The Hospital for Special Surgery","PRINCIPAL_INVESTIGATOR",[112],{"name":113,"role":114,"phone":115,"phoneExt":43,"email":116},"Grace Wang, BA","CONTACT","212-774-2121","wangg@hss.edu",[118,140,175],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Children's Healthcare of Atlanta","RECRUITING","Atlanta","Georgia","30342","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-84.38798,33.749,{"lat":130,"lon":129},[133,137],{"name":134,"role":114,"phone":135,"phoneExt":43,"email":136},"Jack Goldberg, MS","(678) 686-6864","Jack.Goldberg@choa.org",{"name":138,"role":114,"phone":139,"phoneExt":43,"email":43},"Tim Schrader, MD","(404) 255-1933",{"facility":141,"status":120,"city":142,"state":142,"zip":143,"country":124,"countryCode":125,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Hospital for Special Surgery","New York","10021",{"type":127,"coordinates":145},[146,147],-74.00597,40.71427,{"lat":147,"lon":146},[150,151,153,154,157,159,161,163,165,167,169,171,173],{"name":113,"role":114,"phone":115,"phoneExt":43,"email":116},{"name":108,"role":114,"phone":152,"phoneExt":43,"email":43},"212-606-1451",{"name":108,"role":110,"phone":43,"phoneExt":43,"email":43},{"name":155,"role":156,"phone":43,"phoneExt":43,"email":43},"Joseph J Ruzbarsky, MD","SUB_INVESTIGATOR",{"name":158,"role":156,"phone":43,"phoneExt":43,"email":43},"Roger F Widmann, MD",{"name":160,"role":156,"phone":43,"phoneExt":43,"email":43},"Daniel W Green, MD",{"name":162,"role":156,"phone":43,"phoneExt":43,"email":43},"John S Blanco, MD",{"name":164,"role":156,"phone":43,"phoneExt":43,"email":43},"David M Scher, MD",{"name":166,"role":156,"phone":43,"phoneExt":43,"email":43},"Shevaun M Doyle, MD",{"name":168,"role":156,"phone":43,"phoneExt":43,"email":43},"Peter D Fabricant, MD, MPH",{"name":170,"role":156,"phone":43,"phoneExt":43,"email":43},"Christine M Salvatore, MD",{"name":172,"role":156,"phone":43,"phoneExt":43,"email":43},"Matthew Greenblatt, MD, PhD",{"name":174,"role":156,"phone":43,"phoneExt":43,"email":43},"Huong Do, MS",{"facility":176,"status":177,"city":178,"state":179,"zip":180,"country":124,"countryCode":125,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Campbell Clinic","NOT_YET_RECRUITING","Collierville","Tennessee","38017",{"type":127,"coordinates":182},[183,184],-89.66453,35.04204,{"lat":184,"lon":183},[187,191],{"name":188,"role":114,"phone":189,"phoneExt":43,"email":190},"Jonathan Rowland","(901) 287-5413","Jonathan.Rowland@lebonheur.org",{"name":192,"role":114,"phone":193,"phoneExt":43,"email":43},"Derek Kelly, MD","(901) 759-3100",{"type":195,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[197,199,200,201],{"name":198,"class":6},"Pediatric Orthopaedic Society of North America",{"name":119,"class":6},{"name":176,"class":6},{"name":202,"class":203},"CD Diagnostics","INDUSTRY","100339842","alpha-defensin-and-synovial-proteins-to-improve-detection-of-pediatric-septic-arthritis-100339842",false,"NCT03704766","Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis","Inclusion Criteria- Septic Cases and Inflamed, Non-Septic Comparators:\n\n* Synovial fluid is obtained to assess for infection or inflammatory\u002Frheumatologic disease (all medium and large joints will be included: hip, knee, ankle, shoulder, subtalar, elbow, and wrist joints)\n* Patients with recent antibiotic exposure are eligible to participate but will be analyzed separately\n\nInclusion Criteria- Normative Controls:\n\n* Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)\n\nExclusion Criteria- All Participants:\n\n* Family declines to participate\u002Fconsent\n* Patients with a major joint trauma (such as a documented ligament tear or fracture) within the past 8 weeks are not eligible to have that joint aspirated, but could have another joint aspirated\n\nExclusion Criteria- Normative Controls:\n\n* A history of recent infection (within the past 3 months)\n* Received antibiotics in the past 7 days","ALL","17 Years",{"count":213,"type":214},442,"ESTIMATED","INTERVENTIONAL",[217],"NA","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.",[220,221,222,223],"Joint Infection","Infection of Hip Joint (Disorder)","Infection of Shoulder Joint","Septic Arthritis",[225,226,227,228],"synovial biomarkers","alpha-defensin","diagnostics","pediatric","2025-06-17",{"date":231,"type":232},"2025-06-22","ACTUAL",{"date":234,"type":232},"2016-06-28",{"date":236,"type":214},"2026-05",{"name":5,"class":6},3]