Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 11:09 AM
Study NCT ID:
NCT06046404
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D014954', 'term': 'Wrist Injuries'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070628', 'term': 'Closed Fracture Reduction'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'cluster randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily pain scores', 'timeFrame': 'usually 2-10 days', 'description': 'pain reported in the days awaiting surgery on the visual analog scale (VAS) scoring from 0 to 10 where 0 equals no pain and 10 the worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'function', 'timeFrame': '6 weeks, 3, 6 and 12 months', 'description': 'hand function as reported by the patient reported hand and wrist evaluation (PRHWE) questionnaire. scoring from 0 to 100 with 0 meaning perfect function with no impairment or pain and 100 meaning no function at all with maximum pain.'}, {'measure': 'Number of complications', 'timeFrame': '1 year', 'description': 'The investigators will report all complications including, but not limited to: nerve damage, CRPS, infection, bleeding, malunion and need for revision surgery will be tracked.'}, {'measure': 'Wrist mobility', 'timeFrame': '6 weeks and 3 months', 'description': 'Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.'}, {'measure': 'length of stay in emergency department', 'timeFrame': 'baseline', 'description': 'length of stay in emergency department'}, {'measure': 'quality of life in EQ5D5L', 'timeFrame': '1 year', 'description': 'reported by the EQ5D5L questionnaire. EQ-5D-5L health states can be summarised using a 5-digit code or represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrist Fractures', 'Distal Radius Fractures', 'Closed Reduction of Fracture and Application of Plaster Cast', 'Wrist Injuries', 'Radius Fracture Distal']}, 'descriptionModule': {'briefSummary': 'The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.', 'detailedDescription': 'in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* displaced distal radial fracture eligible for surgery\n\nExclusion Criteria:\n\n* ISS traumascore \\>16\n* open fracture\n* multiple fractures in ipsilateral extremety\n* neurovascular damage\n* previous injury in the same wrist\n* inability to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT06046404', 'acronym': 'RECORDED', 'briefTitle': 'Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Maasstad Hospital'}, 'officialTitle': 'Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department', 'orgStudyIdInfo': {'id': 'L2022093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'closed reduction followed by plaster casting', 'interventionNames': ['Procedure: closed reduction']}, {'type': 'EXPERIMENTAL', 'label': 'only plaster casting', 'description': 'no closed reduction will be performed', 'interventionNames': ['Procedure: no closed reduction']}], 'interventions': [{'name': 'closed reduction', 'type': 'PROCEDURE', 'description': 'the intervention of closed fracture reduction widely known and part of daily practice. we test the eficacy of this intervention by not performing it in our test group.', 'armGroupLabels': ['closed reduction followed by plaster casting']}, {'name': 'no closed reduction', 'type': 'PROCEDURE', 'description': 'no reduction will be performed', 'armGroupLabels': ['only plaster casting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3079 DZ', 'city': 'Rotterdam', 'state': 'Maasstadweg 21', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bas M Derksen, MsC', 'role': 'CONTACT', 'email': 'DerksenB@maasstadziekenhuis.nl', 'phone': '+31618027390'}], 'facility': 'Maasstad Hospital', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Bas M Derksen, MsC', 'role': 'CONTACT', 'email': 'DerksenB@maasstadziekenhuis.nl', 'phone': '0031618027390'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maasstad Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}