Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT03507933
Status:
UNKNOWN
Last Update Posted:
2018-04-25
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013585', 'term': 'Synovitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the range of motion of the hip in degrees', 'timeFrame': 'before surgery and 4 months after surgery', 'description': 'Evaluation of extension / flexion / abduction / adduction / external rotation / internal rotation of the hip'}, {'measure': 'Incidence of signal changes in the X-Ray', 'timeFrame': '4 months after surgery'}, {'measure': 'Incidence of signal changes in the MRI', 'timeFrame': '4 months after surgery'}], 'secondaryOutcomes': [{'measure': "Change from baseline in the scale measure of patient's pain intensity", 'timeFrame': 'before surgery and 4 months after surgery'}, {'measure': 'Incidence of complications after surgery', 'timeFrame': '4 month after surgery'}, {'measure': 'Number of additional treatments used in addition to surgery', 'timeFrame': '4 month after surgery', 'description': 'Frequency of adjuvant treatments'}, {'measure': 'Change from baseline in the physical activity evaluated by a questionnaire', 'timeFrame': 'before surgery and 4 months after surgery', 'description': 'yes /no questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['villo-nodular synovitis', 'Hip', 'Surgery'], 'conditions': ['Synovitis']}, 'descriptionModule': {'briefSummary': "Villo-nodular synovitis can affect the joints, bursae or tendon sheaths. This condition is rare, with 1.8 cases per million inhabitants. The hip is affected in 3.6 to 18.1% of cases. The age of predilection is between 30 and 50 years old and this condition is rarely described in children.\n\nTwo articles report a case of villous-nodular synovitis of the child's hip. Surgical treatment by resection seems to be consensus but various adjuvant treatments are also proposed. A case of villous-nodular synovitis of the hip in children was treated without surgical intervention. The main objective of this study was to evaluate the efficacy of surgical treatment of villous nodular synovitis of the hip in children.", 'detailedDescription': 'French multicentric cases serie'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children operated for villo-nodular synovitis of the hip', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with histologically villo-nodular synovitis of the hip\n* Surgical procedures performed for the treatment of this synovitis\n\nExclusion Criteria:\n\n* Degree of bone maturation and Risser test greater than 4 at the time of diagnosis\n* Parents opposing the use of their child's data / Patient opposing the use of his/her data"}, 'identificationModule': {'nctId': 'NCT03507933', 'acronym': 'SVN', 'briefTitle': 'Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children', 'organization': {'class': 'OTHER', 'fullName': 'Lille Catholic University'}, 'officialTitle': 'Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series', 'orgStudyIdInfo': {'id': 'OBS-0033'}}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Lille Catholic University', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Amélie Lansiaux, MD, PhD', 'role': 'CONTACT', 'email': 'lansiaux.amelie@ghicl.net', 'phone': '+ 33 320225269'}, {'name': 'Justine Monvoisin', 'role': 'CONTACT', 'email': 'monvoisin.justine@ghicl.net', 'phone': '+33 320223884'}], 'overallOfficials': [{'name': 'Raphael Coursier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lille Catholic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lille Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}