Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT06738693
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney", 'timeFrame': '24 weeks post-surgery', 'description': "The primary outcome will be the functional outcome of the wrist assessed using the Green and O'Brien scoring system modified by Cooney. This scoring system evaluates four components: pain, function, range of motion, and grip strength, each weighted appropriately to provide a composite score. Scores will be compared between the external fixation and volar plating groups to determine the superiority of either intervention in restoring wrist function."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radius Fractures']}, 'descriptionModule': {'briefSummary': "The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:\n\nDoes the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.\n\nParticipants will:\n\nUndergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.\n\nFollow a postoperative rehabilitation plan, including active and passive range of motion exercises.\n\nAttend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Diagnosed with recent (\\<1 week) intra-articular distal end radius fractures.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Open fractures classified as Gustilo grade II or higher.\n* Fracture avulsion or dislocation.\n* Vascular injury associated with the fracture.\n* Extra-articular fractures of the distal radius.\n* Preexisting joint or carpal bone disease affecting rehabilitation.\n* Patients unwilling to provide consent.'}, 'identificationModule': {'nctId': 'NCT06738693', 'briefTitle': 'External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'B.P. Koirala Institute of Health Sciences'}, 'officialTitle': 'External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes', 'orgStudyIdInfo': {'id': 'IRC/1656/019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External Fixation', 'description': 'Patients in this arm will undergo external fixation for unstable intra-articular distal radius fractures. The procedure involves the placement of an external fixator to stabilize the fracture, followed by postoperative care including pin tract cleaning and removal of the fixator after radiological confirmation of bone healing (6-8 weeks). Functional outcomes, fracture union, and complications will be assessed at regular intervals.', 'interventionNames': ['Procedure: External Fixation']}, {'type': 'EXPERIMENTAL', 'label': 'Volar Locking Plate', 'description': 'Patients in this arm will undergo open reduction and internal fixation (ORIF) using a volar locking plate for unstable intra-articular distal radius fractures. This method provides stable fixation, allowing early mobilization. Postoperative outcomes, including functional scores, union rates, and complications, will be evaluated at follow-up visits.', 'interventionNames': ['Procedure: Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate']}], 'interventions': [{'name': 'External Fixation', 'type': 'PROCEDURE', 'description': 'External fixation involves the stabilization of unstable intra-articular distal radius fractures using an external fixator. The procedure is performed under anesthesia, with fixator pins placed percutaneously into the proximal and distal fragments of the radius. Postoperative care includes regular cleaning of pin tracts, early mobilization exercises for adjacent joints, and fixator removal upon radiological confirmation of fracture healing, typically between 6 to 8 weeks post-surgery.', 'armGroupLabels': ['External Fixation']}, {'name': 'Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate', 'type': 'PROCEDURE', 'description': 'ORIF using a volar locking plate is performed to anatomically reduce and stabilize unstable intra-articular distal radius fractures. The procedure is conducted under anesthesia, involving an open approach through the volar aspect of the wrist. The volar locking plate is secured with screws to provide rigid fixation, enabling early mobilization. Postoperative follow-up includes evaluation of functional outcomes, union rates, and potential complications.', 'armGroupLabels': ['Volar Locking Plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56700', 'city': 'Dharān', 'state': 'Koshi', 'country': 'Nepal', 'facility': 'BPKIHS', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual Participant Data (IPD) will be shared with other researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.P. Koirala Institute of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Sabir Kumar Khadka', 'investigatorAffiliation': 'B.P. Koirala Institute of Health Sciences'}}}}