Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05531227
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2022-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001170', 'term': 'Arthritis, Infectious'}, {'id': 'D013585', 'term': 'Synovitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete regression of the pain in a fast way', 'timeFrame': '6 months after treatment with corticosteroids'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthritis, Septic', 'synovitis', 'Corticosteroid therapy', 'Inflammatory response', 'Native joint'], 'conditions': ['Arthritis, Septic']}, 'descriptionModule': {'briefSummary': 'Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.\n\nCorticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.\n\nThere are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patient (≥18 years old)\n* having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021\n* clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment\n* having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ\n* having had treatment with local or systemic corticosteroids.\n\nExclusion criteria:\n\n* Patient who has expressed his opposition to the reuse of his data for scientific research purposes.\n* Absence of corticosteroid treatment'}, 'identificationModule': {'nctId': 'NCT05531227', 'acronym': 'SYNOVITIS', 'briefTitle': 'Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint', 'orgStudyIdInfo': {'id': '8654'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeannot GAUDIAS, MD', 'role': 'CONTACT', 'email': 'jeannot.gaudias@chru-strasbourg.fr', 'phone': '33 3 68 76 50 64'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}, {'name': 'Jeannot GAUDIAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alia BARTHEL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Jeannot GAUDIAS, MD', 'role': 'CONTACT', 'email': 'jeannot.gaudias@chru-strasbourg.fr', 'phone': '33 3 68 76 50 64'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr'}], 'overallOfficials': [{'name': 'Jeannot GAUDIAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}