Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04952220
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
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': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of the ultrasound abnormalities seen in native septic arthritis of the knee', 'timeFrame': 'Day0, Day 10 or before surgery, 6week, 3months, 6months', 'description': 'Describe the ultrasonographic abnormalities seen in native septic arthritis of the knee'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound Therapy; Complications', 'Septic Arthritis', 'Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.\n\nPrimary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.', 'detailedDescription': 'Secondary Objectives:\n\n1. Search for poor prognostic factors in native septic arthritis of the knee.\n2. To look for an association between initial sonographic factors and the use of joint lavage.\n3. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with native septic arthritis of the knee', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of legal age\n* Bacteriologically proven native septic arthritis\n* Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation\n* Free subject, without guardianship or trusteeship, or subordination\n* Non-opposition of the patient after clear and fair information about the study\n\nExclusion Criteria:\n\n* Presence of material in the affected joint\n* Arthritis with Mycobacterium Tuberculosis.\n* Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection'}, 'identificationModule': {'nctId': 'NCT04952220', 'acronym': 'USAK', 'briefTitle': 'Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee', 'orgStudyIdInfo': {'id': '2021-A01301-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'native septic arthritis of the knee', 'description': 'Describe the ultrasound abnormalities observed at D0, D10 or before surgery, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee:\n\nthickness and vascularity of the synovial membrane, existence and measurement of joint effusion existence of articular partitioning, erosions and adjacent soft tissue involvement (muscle abscess, cellulitis)', 'interventionNames': ['Device: ultrasound']}], 'interventions': [{'name': 'ultrasound', 'type': 'DEVICE', 'description': 'Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee', 'armGroupLabels': ['native septic arthritis of the knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Le GOFF Benoit', 'role': 'CONTACT', 'email': ':Benoit.LEGOFF@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Angoulême', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'RICHE Agnes', 'role': 'CONTACT', 'email': 'agnes.riche@ch-angouleme.fr'}], 'facility': "CH D'Angouleme", 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CORMIER Grégoire', 'role': 'CONTACT', 'email': 'gregoire.cormier@chd-vendee.fr'}], 'facility': 'CH de La roche-sur-yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '17019', 'city': 'La Rochelle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MARTIN Claire', 'role': 'CONTACT', 'email': 'Claire.MARTIN@ch-larochelle.fr'}], 'facility': 'CH De La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Niort', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian LORMEAU', 'role': 'CONTACT', 'email': 'christian.lormeau@ch-niort.fr'}], 'facility': 'CH de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rachel BRAULT', 'role': 'CONTACT', 'email': 'rachel.brault@chu-poitiers.fr'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35203', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivia BERTHOUD', 'role': 'CONTACT', 'email': 'olivia.berthoud@chu-rennes.fr'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'GERVAIS Elisabeth', 'role': 'CONTACT', 'email': 'elisabeth.gervais@chu-poitiers.fr', 'phone': '05 49 44 44 65'}], 'overallOfficials': [{'name': 'GERVAIS Elisabeth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}