Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-28 @ 9:42 PM
Study NCT ID:
NCT06260761
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-05', 'size': 1309374, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-04T06:00', 'hasProtocol': True}, {'date': '2021-10-05', 'size': 80882, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-04T06:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Visual analogue scale', 'timeFrame': 'Postoperative day 0-7 and 2,6,10,14,24 weeks', 'description': 'pain 0-10, minimum = 0 (best) , maximum = 10 (worst)'}], 'secondaryOutcomes': [{'measure': 'Quick Disabilities of the Arm, Shoulder and Hand', 'timeFrame': 'Postoperative 2,6,10,14,24 weeks', 'description': 'functional score 0-100 , minimum = 0 (best) , maximum = 100 (worst)'}, {'measure': 'Grip strength', 'timeFrame': 'Postoperative 2,6,10,14,24 weeks', 'description': 'compare with normal side 0-100%'}, {'measure': 'Pinch strength', 'timeFrame': 'Postoperative 2,6,10,14,24 weeks', 'description': 'compare with normal side %'}, {'measure': 'Range of motion', 'timeFrame': 'Postoperative 2,6,10,14,24 weeks', 'description': 'flexion extension pronation supination ulnar and radial deviation (degree)'}, {'measure': 'Aesthetics', 'timeFrame': 'Postoperative 24 weeks', 'description': 'range 0-5; 0=bad 3=so so 5=good'}, {'measure': 'Satisfy', 'timeFrame': 'Postoperative 24 weeks', 'description': 'range 0-5; 0=Unsatisfied 3=so so 5=Satisfy'}, {'measure': 'Volar tile', 'timeFrame': 'Postoperative 2, 24 weeks', 'description': 'radiographic parameter (degree)'}, {'measure': 'ulnar variance', 'timeFrame': 'Postoperative 2, 24 weeks', 'description': 'radiographic parameter (centimeter)'}, {'measure': 'radial inclination', 'timeFrame': 'Postoperative 2, 24 weeks', 'description': 'radiographic parameter (degree)'}, {'measure': 'operation time', 'timeFrame': 'Intraoperative', 'description': '(minute)'}, {'measure': 'skin incision', 'timeFrame': 'Postoperative 2 weeks', 'description': '(centimeter)'}, {'measure': 'morphine IV use', 'timeFrame': 'Postoperative day 0-2', 'description': '(milligram)'}, {'measure': 'complication', 'timeFrame': 'up to 24 weeks', 'description': 'Number of Participants with complication and adverse event'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MIPO', 'distal end radius fracture', 'WALANT'], 'conditions': ['Radius; Fracture, Lower or Distal End']}, 'referencesModule': {'references': [{'pmid': '28725505', 'type': 'RESULT', 'citation': 'Pire E, Hidalgo Diaz JJ, Salazar Botero S, Facca S, Liverneaux PA. Long Volar Plating for Metadiaphyseal Fractures of Distal Radius: Study Comparing Minimally Invasive Plate Osteosynthesis versus Conventional Approach. J Wrist Surg. 2017 Aug;6(3):227-234. doi: 10.1055/s-0037-1599791. Epub 2017 Mar 16.'}, {'pmid': '33153957', 'type': 'RESULT', 'citation': 'Vernet P, Gouzou S, Hidalgo Diaz JJ, Facca S, Liverneaux P. Minimally invasive anterior plate osteosynthesis of the distal radius: A 710 case-series. Orthop Traumatol Surg Res. 2020 Dec;106(8):1619-1625. doi: 10.1016/j.otsr.2020.04.024. Epub 2020 Nov 3.'}, {'pmid': '21464735', 'type': 'RESULT', 'citation': 'Zenke Y, Sakai A, Oshige T, Moritani S, Fuse Y, Maehara T, Nakamura T. Clinical results of volar locking plate for distal radius fractures: conventional versus minimally invasive plate osteosynthesis. J Orthop Trauma. 2011 Jul;25(7):425-31. doi: 10.1097/BOT.0b013e3182008c83.'}, {'pmid': '28246046', 'type': 'RESULT', 'citation': 'Zhang X, Huang X, Shao X, Zhu H, Sun J, Wang X. A comparison of minimally invasive approach vs conventional approach for volar plating of distal radial fractures. Acta Orthop Traumatol Turc. 2017 Mar;51(2):110-117. doi: 10.1016/j.aott.2017.02.013. Epub 2017 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches.', 'detailedDescription': 'Gap of knowledge\n\n* No comparison of conventional Versus MIPO technique under WALANT\n* No result in acute post-operative pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated closed fractures of the distal end radius requiring surgery\n* aged 18 years and older\n\nExclusion Criteria:\n\n* Patients with bone fractures lasting more than 21 days\n* open fractures\n* articular multi-fragmentary comminuted fractures of the distal radius\n* not suitable to undergo volar approach surgery\n* individuals with combined carpal fractures or dislocation\n* ulna fractures\n* associated injuries\n* a history of previous wrist surgery\n* diabetes mellitus\n* chronic wrist inflammation\n* wrist bone deformities\n* the use of anticoagulation drugs\n* uncooperative behavior\n* those refusing to participate in the research'}, 'identificationModule': {'nctId': 'NCT06260761', 'briefTitle': 'MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT', 'organization': {'class': 'OTHER', 'fullName': 'Police General Hospital, Thailand'}, 'officialTitle': 'Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar Locking Plate for Close Fractures of Distal End Radius Under WALANT', 'orgStudyIdInfo': {'id': 'Dh3108103/64'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIPO', 'description': 'isolated close fracture of distal end radius', 'interventionNames': ['Procedure: MIPO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'isolated close fracture of distal end radius', 'interventionNames': ['Procedure: Conventional']}], 'interventions': [{'name': 'MIPO', 'type': 'PROCEDURE', 'description': 'minimal invasive surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT', 'armGroupLabels': ['MIPO']}, {'name': 'Conventional', 'type': 'PROCEDURE', 'description': 'standard surgery with Volar locking plate fixation in isolated close fracture of distal radius under WALANT', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Police general hospital', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'overallOfficials': [{'name': 'suphasan keatisuwan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Police general hospital, Bangkok, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Police General Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suphasan Keatisuwan', 'investigatorAffiliation': 'Police General Hospital, Thailand'}}}}