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IRCT20200313046759N1 IRCT 2021-10-25 Mashhad University of Medical Sciences Effect of applying distortion force on distal radial fractures Investigating the effect of applying distortion force on distal radial fractures parallel to radius shaft and perpendicular to joint in radiology and clinic 2020-09-22 anticipated 50 Complete https://irct.ir/trial/48777 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization is simple. Unit of randomization is individual. Randomization tool is sealed envelops. For each patient with inclusion criteria, a sealed envelope is taken and patient's group determined accordingly. As using wrist external fixator, allocation concealment is impossible for neither the patient nor the surgeon. 2-3 Distal radius fracture. Intervention 1: Intervention group 1: In sterile condition of operating room under general anesthesia and prep and drape, first closed reduction with appropriate maneuver is done. Then 2 two millimeters schanz pins in second metacarpus and 2 two millimeters schanz pins in radius shaft is inserted in lateral side. Then Avisa Co. wrist external fixator is attached to these schanz pins. We put radial inclination and palmar tilt indices to zero value and distraction force is applied in parallel to radius shaft. All procedures were checked by fluoroscopy. Intervention 2: Intervention group 2: In sterile condition of operating room under general anesthesia and prep and drape, first closed reduction with appropriate maneuver is done. Then 2 two millimeters schanz pins in second metacarpus and 2 two millimeters schanz pins in radius shaft is inserted in lateral side. Then Avisa Co. wrist external fixator is attached to these schanz pins. We put radial inclination and palmar tilt indices as the other side values and distraction force is applied perpendicular to distal radius joint line. All procedures were checked by fluoroscopy. Yes - There is a plan to make this available What will be shared: Potentially all collected deidentified IPD could be shared When: starting 6 months after publication To whom: people working in academic institutions Conditions: Potentially, academic use of all data is possible Where to obtain: Please contact with below email in order to request data: Moradial@mums.ac.ir How to obtain: 2 working weeks after receiving request email Comments:
public Ali Moradi
Orthopedic Research Center, Quaem Hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 7453 Moradial@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Moradi
Orthopedic Research Center, Quaem Hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 7453 Moradial@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Acute unilateral distal radial fracture with above 5 millimeter shortening or intra-articular 18 years 60 years Both bilateral fracture Inflammatory disease of involved side open fracture History of any previous fracture in either right or left wrist S52.5 Fracture of lower end of radius Treatment - Surgery Treatment - Surgery Intervention group 1: In sterile condition of operating room under general anesthesia and prep and drape, first closed reduction with appropriate maneuver is done. Then 2 two millimeters schanz pins in second metacarpus and 2 two millimeters schanz pins in radius shaft is inserted in lateral side. Then Avisa Co. wrist external fixator is attached to these schanz pins. We put radial inclination and palmar tilt indices to zero value and distraction force is applied in parallel to radius shaft. All procedures were checked by fluoroscopy. Intervention group 2: In sterile condition of operating room under general anesthesia and prep and drape, first closed reduction with appropriate maneuver is done. Then 2 two millimeters schanz pins in second metacarpus and 2 two millimeters schanz pins in radius shaft is inserted in lateral side. Then Avisa Co. wrist external fixator is attached to these schanz pins. We put radial inclination and palmar tilt indices as the other side values and distraction force is applied perpendicular to distal radius joint line. All procedures were checked by fluoroscopy. Palmar tilt. Timepoint: 6 weeks after the surgery. Method of measurement: in degrees in 6 weeks post-op lateral wrist radiography. Radial inclination. Timepoint: 6 weeks after the surgery. Method of measurement: in degrees in 6 weeks post-op anteroposterior wrist radiography. Pain. Timepoint: before surgery, immediately after the surgery, 6 weeks after the surgery. Method of measurement: Visual analogue scale. Wrist function. Timepoint: 6 weeks after the surgery. Method of measurement: Modified Mayo wrist score. Wrist function. Timepoint: 6 weeks after the surgery. Method of measurement: Patient-Rated Wrist Evaluation questionnaire. Wrist function. Timepoint: 6 weeks after the surgery. Method of measurement: Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Mashhad University of Medical Sciences Approved 2019-01-01 Ethics committee of Mashhad University of Medical Sciences Orthopedics research center, Quaem Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)