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IRCT20160508027797N4 IRCT 2019-03-11 Babol University of Medical Sciences Comparison outcome of unstable fractures of the distal radius bone between the two surgical methods of unstable fractures of the distal radius bone between the two surgical methods Outcomes of unstable intera articular distal radius fracture using closed reduction, percutaneous pinning and plaster cast compared with closed reduction and plaster cast in patient older than 65 years 2018-12-30 anticipated 60 Complete https://irct.ir/trial/37510 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly divided into two groups. In this study, toss to generate a random sequence in the trial will be two groups. So that one of the study groups is Milk and the other is the line, and based on the sample size, the same number of coins will be thrown, and the individuals will be randomly assigned to two groups. Group line patients treated with closed reduction and pinning and milk treated with closed reduction and casting will be, Blinding description: Patients will not be aware of the treatment they are taking, and this will be blinded. N/A Distal radius fracture. Intervention 1: Intervention group: In patients reduction and casting, closed reduction of fracture with in the first 24 hours and then by stretching and manipulation under general anesthesia for closed reduction of fracture is tried. After the reduction approved by the ray casting is conducted at casting method does not need to roll the fabric. Intervention 2: Control group: In percutaneous pining first closed reduction of fracture under general anesthesia in the first 24 hours was (stretching and manipulation attempts at closed reduction of fracture with the help of rolls of fabric to a height of 20 cm below the wrist placed) then 3 pins 2mm diameter entering a pin in the radial styloid volar radius in the arm and the other arm on the dorsal side and one on the ulnar, radial pin total of 3 proved to be, taken. C-arm fluoroscopy control pin will be approved and then took a long chalk. No - There is not a plan to make this available Justification or reason for not sharing IPD is .
public Dr. Masoud Bahrami Ferydoni
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 6285 Drbahrami865@gmail.com Babol University of Medical Sciences scientific Dr. Masoud Bahrami Ferydoni
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 6285 Drbahrami865@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 65-95 years Patients with closed fractures and intra-articular distal radius that needed to be fixed surgery Informed consent of patient in the study 65 years 95 years Both Surgery on wrist Severe underlying disease Lack of timely referral for follow-up therapy to the orthopedic clinic S52.5 Fracture of lower end of radius Treatment - Surgery Treatment - Surgery Intervention group: In patients reduction and casting, closed reduction of fracture with in the first 24 hours and then by stretching and manipulation under general anesthesia for closed reduction of fracture is tried. After the reduction approved by the ray casting is conducted at casting method does not need to roll the fabric. Control group: In percutaneous pining first closed reduction of fracture under general anesthesia in the first 24 hours was (stretching and manipulation attempts at closed reduction of fracture with the help of rolls of fabric to a height of 20 cm below the wrist placed) then 3 pins 2mm diameter entering a pin in the radial styloid volar radius in the arm and the other arm on the dorsal side and one on the ulnar, radial pin total of 3 proved to be, taken. C-arm fluoroscopy control pin will be approved and then took a long chalk. Range of motion of wrist. Timepoint: Immediately after surgery, then the three and the sixth and the forty- second weeks after surgery. Method of measurement: Through the examination with handheld goniometer. Determination Radio graphic parameters. Timepoint: Immediately after surgery, then the thre e and the sixth and the forty- second weeks after surgery. Method of measurement: Measurement reference markers in the radiographic image. Pain severity. Timepoint: Forty-second weeks after surgery. Method of measurement: By Visual Analogous Scale questionnaire. Pin tract infection. Timepoint: Three weeks after surgery. Method of measurement: Observation. Babol University of Medical Sciences Approved 2018-12-30 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)