Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 6:08 AM
Study NCT ID:
NCT07276334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Same Day Discharge Vs. Hospitalization for Operative Fixation of Distal Radius Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-11-29', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire,', 'timeFrame': 'from surgery to one year after', 'description': 'A self-report tool (0-100) measuring upper limb function, where higher scores mean more disability,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fracture Fixation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the results for same-day discharge after distal radius operative fixation in adult pupolation. The main questions it aims to answer are:\n\nIs same day discharge safe and effective for distal radius fractures? Are the functional and patient reported outcome measures results different between same day discharge and hospitalized patients? Researchers will compare same day discharge patients with jospitalized patients to see if there are any differences between the groups\n\nParticipants will:\n\n* undergo surgery\n* atend outpatient clinical follow up visits\n* answer dedicated questioneres'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years and\n* diagnosed with a DRF requiring surgical intervention and\n* booked for surgery\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* lack of follow-up\n* incomplete clinical or radiologic documentation\n* significant cardiac or pulmonary comorbidities\n* inadequate social support at home'}, 'identificationModule': {'nctId': 'NCT07276334', 'briefTitle': 'Same Day Discharge Vs. Hospitalization for Operative Fixation of Distal Radius Fractures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Outpatient vs. Inpatient Surgery for Distal Radius Fractures: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'ASF-25-0106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Same-day-discharge', 'interventionNames': ['Procedure: early release from hospital']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hospitalized', 'interventionNames': ['Procedure: Day after surgery release']}], 'interventions': [{'name': 'early release from hospital', 'type': 'PROCEDURE', 'description': 'Same day discharge of patients undergoing distal radius operative fixation', 'armGroupLabels': ['Same-day-discharge']}, {'name': 'Day after surgery release', 'type': 'PROCEDURE', 'description': 'release of patients one day after surgery', 'armGroupLabels': ['Hospitalized']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ofir Vinograd, DR', 'role': 'CONTACT', 'email': 'ofirvin@gmail.com', 'phone': '+972502260335'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ofir Vinograd', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}