protocolSection identificationModule nctId: NCT06260761, orgStudyIdInfo id: Dh3108103/64, briefTitle: MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-05, primaryCompletionDateStruct date: 2023-02-05, completionDateStruct date: 2023-02-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Police General Hospital, Thailand, class: OTHER, 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., conditionsModule conditions: Radius; Fracture, Lower or Distal End, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: MIPO, interventions name: Conventional, outcomesModule primaryOutcomes measure: Pain Visual analogue scale, secondaryOutcomes measure: Quick Disabilities of the Arm, Shoulder and Hand, secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Pinch strength, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Aesthetics, secondaryOutcomes measure: Satisfy, secondaryOutcomes measure: Volar tile, secondaryOutcomes measure: ulnar variance, secondaryOutcomes measure: radial inclination, secondaryOutcomes measure: operation time, secondaryOutcomes measure: skin incision, secondaryOutcomes measure: morphine IV use, secondaryOutcomes measure: complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Police general hospital, city: Pathum Wan, state: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.73649, lon: 100.5239, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-10-05, uploadDate: 2024-02-04T06:00, filename: Prot_SAP_000.pdf, size: 1309374, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-10-05, uploadDate: 2024-02-04T06:05, filename: ICF_001.pdf, size: 80882, hasResults: False