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IRCT20161225031559N2 IRCT 2018-01-21 Vice chancellor for research, Yazd Shahid Sadoughi University of Medical Sciences Comparison of 2 plating technique Comparison of Minimal Invasive and conventional plating methods in treatment of Tibia shaft fracture 2017-11-22 anticipated 40 Complete https://irct.ir/trial/24802 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study through simple random method with the table of random numbers patients assigned to two groups. N/A Tibia shaft fracture. Intervention 1: Control group: After induction of anesthesia and stabilization of vital signs, the open reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with the longitudinal incision on the anterior aspect of leg in the fracture site and bone fixation is done with 8 hole 4.5 millimeter-plate and its screws.Wound closes in various layers under the drain. Dressing and short-leg splint are applied. Intervention 2: Intervention group: After induction of anesthesia and stabilization of vital signs, the reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with two small longitudinal incisions in the proximal and distal parts of fracture. Then the reduction is done in a closed manner and controlled by fluoroscopy. Using a 3.5-millimeter locking plate and its screws fixation are performed without opening the fracture site. The plate is guided from the upper incisions to the distal, and fix with three screws in the proximal and three screws in distal.Wound closes in various layers under the drain. Dressing and short-leg splint are applied. Undecided - It is not yet known if there will be a plan to make this available
public Amir Houshang Mehrparvar
Yazd Shahid Sadoughi university of medical sciences, Bahonar Sq, Yazd.
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3726 3733 ahmehrparvar@ssu.ac.ir Yazd Shahid Sadoughi University of Medical Sciences scientific Seyed Hossein Saeed Banadaki
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
Yazd Iran (Islamic Republic of) 8913814396 +98 35 3626 0000 h.saeed.b@gmail.com Yazd Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) patients with tibial shaft fracture Age range between 18 and 70 years Duration from fracture to surgery less than a week Just types A and B fracture according to AO classification system Informed consent 18 years 70 years Both Patients with fractures in other organs Patients with open fractures head injuries lead to admitting the ICU Burns to the same organ delayed operation more than one week S82.2 Fracture of shaft of tibia Treatment - Surgery Treatment - Surgery Control group: After induction of anesthesia and stabilization of vital signs, the open reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with the longitudinal incision on the anterior aspect of leg in the fracture site and bone fixation is done with 8 hole 4.5 millimeter-plate and its screws.Wound closes in various layers under the drain. Dressing and short-leg splint are applied. Intervention group: After induction of anesthesia and stabilization of vital signs, the reduction, and the fixation are completed with the plate. The surgical procedure is such that after anesthesia the patient is placed on a standard radiolucent table. After the preparation of the limb, bone exposes with two small longitudinal incisions in the proximal and distal parts of fracture. Then the reduction is done in a closed manner and controlled by fluoroscopy. Using a 3.5-millimeter locking plate and its screws fixation are performed without opening the fracture site. The plate is guided from the upper incisions to the distal, and fix with three screws in the proximal and three screws in distal.Wound closes in various layers under the drain. Dressing and short-leg splint are applied. Three of four cortex union time according to x-ray. Timepoint: One week after the surgery, 2 weeks after the surgery, and then every 3 weeks. Method of measurement: Physician examination and X-ray results. Nonunion. Timepoint: From the fifth week after surgery. Method of measurement: X-ray results. Infection. Timepoint: One week after surgery, 2 weeks after surgery, and then every 3 weeks. Method of measurement: Physician examination by specialist. The need for re-surgery. Timepoint: 2 weeks after the surgery and then every 3 weeks. Method of measurement: Physician examination by specialist. Vice chancellor for research, Yazd Shahid Sadoughi University of Medical Sciences Approved 2017-10-02 Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd. Yazd Yazd Iran (Islamic Republic of)