Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-17 @ 10:12 AM
Study NCT ID:
NCT05174702
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Irradiation collected at the end of the operation on the surgeon's active dosimeter", 'timeFrame': 'during the time of the surgery', 'description': 'Measure of irradiation in mSv by a dosimeter'}, {'measure': "Irradiation collected at the end of the operation on the surgeon's active dosimeter", 'timeFrame': 'during the time of the surgery', 'description': 'Measure of irradiation in mGy.cm² by a dosimeter'}], 'secondaryOutcomes': [{'measure': "Irradiation collected at the end of the operation on the patient's and operating team's", 'timeFrame': 'during the time of the surgery', 'description': 'Measure of irradiation in mSv by a dosimeter'}, {'measure': "Irradiation collected at the end of the operation on the patient's and operating team's", 'timeFrame': 'during the time of the surgery', 'description': 'Measure of irradiation in mGy.cm² by a dosimeter'}, {'measure': 'Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional', 'timeFrame': '3 months', 'description': 'Measure of irradiation in mSv by a dosimeter'}, {'measure': 'Irradiation collected on the passive "ring" and "cornea" dosimeters of each health professional', 'timeFrame': '3 months', 'description': 'Measure of irradiation in mGy.cm² by a dosimeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hallux Valgus', 'Surgery']}, 'descriptionModule': {'briefSummary': 'To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.', 'detailedDescription': 'Prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. Patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators.\n\nPatients will be informed of the study during a preoperative visit. The data concerning them will be collected on the day of the surgery. No follow-up over time is necessary.\n\nPassive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. Their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. Several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be managed in accordance with current practice, the choice of surgical strategy for hallus valgus (percutaneous or conventional) being left to the discretion of the investigators.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing percutaneous or conventional hallux valgus surgery;\n* Patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman;\n* Patient under guardianship or curatorship, or under a regime of deprivation of liberty.'}, 'identificationModule': {'nctId': 'NCT05174702', 'acronym': 'RADUS', 'briefTitle': 'Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus', 'orgStudyIdInfo': {'id': '2021-A02408-33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Percutaneous surgery', 'description': 'Patient will have a percutaneous hallus valgus surgery', 'interventionNames': ['Radiation: Irradiation collected at the end of the operation on the active dosimeter']}, {'label': 'conventional surgery', 'description': 'Patient will have a conventional hallus valgus surgery', 'interventionNames': ['Radiation: Irradiation collected at the end of the operation on the active dosimeter']}], 'interventions': [{'name': 'Irradiation collected at the end of the operation on the active dosimeter', 'type': 'RADIATION', 'description': 'Mesure of the irradiation collected at the end of the operation on the active dosimeter for the surgeon, the patient and the operating team', 'armGroupLabels': ['Percutaneous surgery', 'conventional surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Clinique Blomet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}