Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT05790434
Status:
UNKNOWN
Last Update Posted:
2023-03-30
First Post:
2023-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Criteria for Septic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001170', 'term': 'Arthritis, Infectious'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WBC counts', 'timeFrame': 'preoperatively', 'description': 'white blood cell (WBC) counts'}, {'measure': '%PMN', 'timeFrame': 'preoperatively', 'description': 'percent of polymorphonuclear leukocytes (%PMN)'}, {'measure': 'CRP', 'timeFrame': 'preoperatively', 'description': 'concentration of C-reactive protein (CRP)'}, {'measure': 'ESR', 'timeFrame': 'preoperatively', 'description': 'erythrocyte sedimentation rate (ESR)'}, {'measure': 'Albumin', 'timeFrame': 'preoperatively', 'description': 'concentration of albumin'}, {'measure': 'Globulin', 'timeFrame': 'preoperatively', 'description': 'concentration of globulin'}, {'measure': 'Body temperature', 'timeFrame': 'preoperatively', 'description': 'to check whether there has been a fever (\\>37.2°C) previously or now by medical history consultation and physical examination'}, {'measure': 'joint swelling and redness', 'timeFrame': 'preoperatively', 'description': 'to check whether there is joint swelling and redness by visual inspection and palpation'}, {'measure': 'sinus tract', 'timeFrame': 'preoperatively', 'description': 'to check whether there is any sinus tract by visual inspection'}, {'measure': 'positive X-ray findings', 'timeFrame': 'preoperatively', 'description': 'to determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.'}, {'measure': 'positive MR findings', 'timeFrame': 'preoperatively', 'description': 'to determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.'}, {'measure': 'positive pathological findings', 'timeFrame': 'intraoperatively', 'description': 'determined by 5 or more neutrophils per high-power field on histopathologic examination'}, {'measure': 'positive culture', 'timeFrame': 'preoperatively', 'description': 'determined by a bacterial growth when culture of blood or joint fluid in agarose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Septic Arthritis', 'diagnostic criteria'], 'conditions': ['Septic Arthritis']}, 'referencesModule': {'references': [{'pmid': '28366221', 'type': 'BACKGROUND', 'citation': 'Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.'}, {'pmid': '31862240', 'type': 'BACKGROUND', 'citation': 'Abram SGF, Alvand A, Judge A, Beard DJ, Price AJ. Mortality and adverse joint outcomes following septic arthritis of the native knee: a longitudinal cohort study of patients receiving arthroscopic washout. Lancet Infect Dis. 2020 Mar;20(3):341-349. doi: 10.1016/S1473-3099(19)30419-0. Epub 2019 Dec 17.'}, {'pmid': '20206778', 'type': 'BACKGROUND', 'citation': 'Mathews CJ, Weston VC, Jones A, Field M, Coakley G. Bacterial septic arthritis in adults. Lancet. 2010 Mar 6;375(9717):846-55. doi: 10.1016/S0140-6736(09)61595-6.'}, {'pmid': '35747656', 'type': 'BACKGROUND', 'citation': 'Padaki AS, Ma GC, Truong NM, Cogan CJ, Lansdown DA, Feeley BT, Ma CB, Zhang AL. Arthroscopic Treatment Yields Lower Reoperation Rates than Open Treatment for Native Knee but Not Native Shoulder Septic Arthritis. Arthrosc Sports Med Rehabil. 2022 May 27;4(3):e1167-e1178. doi: 10.1016/j.asmr.2022.04.014. eCollection 2022 Jun.'}, {'pmid': '28291183', 'type': 'BACKGROUND', 'citation': 'Johns BP, Loewenthal MR, Dewar DC. Open Compared with Arthroscopic Treatment of Acute Septic Arthritis of the Native Knee. J Bone Joint Surg Am. 2017 Mar 15;99(6):499-505. doi: 10.2106/JBJS.16.00110.'}, {'pmid': '24599649', 'type': 'BACKGROUND', 'citation': 'Shaikh AA, Ha CW, Park YG, Park YB. Two-stage approach to primary TKA in infected arthritic knees using intraoperatively molded articulating cement spacers. Clin Orthop Relat Res. 2014 Jul;472(7):2201-7. doi: 10.1007/s11999-014-3545-6. Epub 2014 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'Septic arthritis (SA) is a rare but highly disabling disease. The ideal diagnosis criteria is not well established. There is an urgent need to establish golden standard for diagnosis.', 'detailedDescription': 'Septic arthritis (SA) is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9-1.3 per 100,000 \\[1, 2\\]. The treatment is challenging and the ideal diagnosis criteria is not well established. The specific tactics employed by relevant researches varied widely \\[3-6\\]. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss \\[2\\]. Therefore, there is an urgent need to establish golden standard for diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'general hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission to orthopaedics\n* complete data\n\nExclusion Criteria:\n\n* Accompanied with fracture\n* Accompanied with other infections\n* Accompanied with immune system diseases'}, 'identificationModule': {'nctId': 'NCT05790434', 'briefTitle': 'Diagnostic Criteria for Septic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Investigation on Diagnostic Criteria for Septic Arthritis：a Multi-center Nested Case-control Study', 'orgStudyIdInfo': {'id': '2022-0909'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with septic arthritis', 'interventionNames': ['Diagnostic Test: Laboratory test', 'Diagnostic Test: History taking and physical examination', 'Diagnostic Test: biopsy']}, {'label': 'Controls', 'description': 'Patients with osteoarthritis, rheumatoid arthritis', 'interventionNames': ['Diagnostic Test: Laboratory test', 'Diagnostic Test: History taking and physical examination', 'Diagnostic Test: biopsy']}], 'interventions': [{'name': 'Laboratory test', 'type': 'DIAGNOSTIC_TEST', 'description': 'including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'History taking and physical examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'including fever, joint pain, local swelling and redness, sinus', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'including arthrocentesis culture，and frozen section', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300001', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mumingjiang Yishake, MD', 'role': 'CONTACT', 'phone': '+86-13868129151'}], 'facility': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310053', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhui Cui, MD', 'role': 'CONTACT', 'email': '21718254@zju.edu.cn', 'phone': '+8618757169516'}], 'facility': 'Zhejiang hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Rongxin He, PhD', 'role': 'CONTACT', 'email': 'herongxin@zju.edu.cn', 'phone': '+8657186518819'}], 'overallOfficials': [{'name': 'Lan Tang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}