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IRCT20230811059117N1 IRCT 2023-08-27 Karaj University of Medical Sciences Evaluation of the effect of using external fixator in conjunction of plate in wrist fracture Comparison between the method of using external fixator with plate in the treatment of comminuted intra-articular fractures of distal radius with the method of using plate alone 2023-09-06 anticipated 52 Complete https://irct.ir/trial/72100 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In the control group, only plaque placement is done, and in the intervention group, in addition to the plaque, an external fixator is also used, Randomization description: For sampling, the block randomization method will be used. Thus, initially in the Excel software, blocks as (AA, BB), (BB, AA), (AB, BA), (BA, AB), ( AB, AB), (BA, BA) will be prepared. A will be for the treatment or intervention group and B will be for the comparison group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the block, people will be selected. Eligible persons will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to intervention and comparison groups will continue until reaching the desired sample size, Blinding description: The data analyst will be blinded so that the analyst does not know which of the study groups the patients belong to. N/A Distal radius fracture. Intervention 1: Intervention group: Use of combined external fixator in addition to plate. Intervention 2: Control group: use of plate alone. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Milad Behzadi
Intersection of Hashemi Rafsanjani and Valiasr Highways, Shahid Rajaei Hospital, Bo Ali Building, Unit 302
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2266 3267 Drmiladbehzadi@gmail.com Karaj University of Medical Sciences scientific Milad Behzadi
Jahanshahr, Shahid madani hospital
Karaj Iran (Islamic Republic of) 3143744693 +98 21 2266 3267 drmiladbehzadi@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) acute intra articular and comminuted fractures of distal radius (AO type c2,c3) age between 18-60 years old 18 years 60 years Both pathologic fractures early osteoprosis alcohol and drug abuse open fracture ( gustilo-anderson type 2 and 3 ) associated fracture ( except for ulnar styloid ) patients with probability of poor compliance S52.5 Fracture of lower end of radius Treatment - Surgery Treatment - Surgery Intervention group: Use of combined external fixator in addition to plate Control group: use of plate alone Function of wrist. Timepoint: 9 months after surgery. Method of measurement: QuickDASH questionnaire. Intensity of pain. Timepoint: 9 months after surgery. Method of measurement: VAS Score. Pin tract infection. Timepoint: The first, third and sixth week after surgery in the clinic. Method of measurement: Physical examination. Surgical site infection. Timepoint: The first, third and sixth week and the sixth and ninth month after surgery in the clinic. Method of measurement: Physical examination. CRPS. Timepoint: The first, third and sixth week and the sixth and ninth month after surgery in the clinic. Method of measurement: Physical examination. Radial height, palmar tilt. Timepoint: First, third, sixth week and ninth month after surgery. Method of measurement: radiography. Non union. Timepoint: sixth month. Method of measurement: radiography. Karaj University of Medical Sciences Approved 2023-07-26 Ethics committee of Alborz University of Medical Sciences Jahanshahr, Madani square, Shahid Madani hospital Karaj Alborz Iran (Islamic Republic of)