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IRCT20190127042514N4 IRCT 2020-02-28 Kerman University of Medical Sciences Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture Comparison of titanium elastic nail, external fixator and casting on prevention of complications in closed diaphyseal tibial fracture in children between 5-12 years old 2017-09-11 anticipated 120 Complete https://irct.ir/trial/44445 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Diaphyseal closed tibia fracture. Intervention 1: Intervention group 1: Patients treated with titanium elastic nail : After choosing the appropriate anesthesia method, the patient was placed supine. The surgical technique began with a closed reduction on the axial axis. Then, under sterile conditions, two surgical incisions in length 20 mm from 10 to 30 mm from the proximal tibial growth plate were made under the fluoroscopic guide on both the inner and outer sides of the lower limb skin. To select the proper Nail diameter after estimating the narrowest part of the central bone channel by imaging the Flynn's equation was used:nail diameter = 0.4 × the diameter of the medullary canal After selecting the appropriate Nail, drill the posterior middle part of proximal metaphysis near the posterior-inner edge of the tibia within 10 cm of the growth plate, then nail medial was inserted by T-handle and the nail end was inserted to the metaphysis. Then, 2 cm away from the nail. After Nail Medial placement, lateral Nail was inserted in the same way. Intervention 2: Intervention group 2: Patients treated with external fixator: In sterile conditions and under the guide fluorescence, the place of pin was identified and the incision was made. Then the bone and pin were inserted with the appropriate drill and a monolateral external fixator with two rods and four pins was inserted. Intervention 3: Intervention group 3: Patients treated with casting:The patient was plastered with a long leg plaster at a knee angle of 20 to 40 degrees to prevent embolism and rest of the Gastrocnemius muscle as well as to provide rotational stability, prior to casting if there was significant displacement, under anesthesia in the emergency or operating room. reduction was done. No - There is not a plan to make this available Justification or reason for not sharing IPD is No subscription required
public Amirreza Mirzaei Sosafidi
Qarani Ave
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 amirreza.mirzaei@live.com Kerman University of Medical Sciences scientific Amirreza Mirzaei Sosafidi
Qarani Ave
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 amirreza.mirzaei@live.com Kerman University of Medical Sciences Iran (Islamic Republic of) Being at the age of 5-12 years old Closed diaphyseal fracture of the tibia 5 years 12 years Both Open fracture Pathological fracture Metabolic disease Congenital deformities of the skeletal system Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: Patients treated with titanium elastic nail : After choosing the appropriate anesthesia method, the patient was placed supine. The surgical technique began with a closed reduction on the axial axis. Then, under sterile conditions, two surgical incisions in length 20 mm from 10 to 30 mm from the proximal tibial growth plate were made under the fluoroscopic guide on both the inner and outer sides of the lower limb skin. To select the proper Nail diameter after estimating the narrowest part of the central bone channel by imaging the Flynn's equation was used:nail diameter = 0.4 × the diameter of the medullary canal After selecting the appropriate Nail, drill the posterior middle part of proximal metaphysis near the posterior-inner edge of the tibia within 10 cm of the growth plate, then nail medial was inserted by T-handle and the nail end was inserted to the metaphysis. Then, 2 cm away from the nail. After Nail Medial placement, lateral Nail was inserted in the same way Intervention group 2: Patients treated with external fixator: In sterile conditions and under the guide fluorescence, the place of pin was identified and the incision was made. Then the bone and pin were inserted with the appropriate drill and a monolateral external fixator with two rods and four pins was inserted. Intervention group 3: Patients treated with casting:The patient was plastered with a long leg plaster at a knee angle of 20 to 40 degrees to prevent embolism and rest of the Gastrocnemius muscle as well as to provide rotational stability, prior to casting if there was significant displacement, under anesthesia in the emergency or operating room. reduction was done Patient satisfaction. Timepoint: 2, 6 and 12 months later. Method of measurement: Using the Medical Outcomes Study Short Form 12 (SF-12) and Oxford Score questionnaire according to surgical outcome criteria. Non fusion. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation. Refracture. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation. Angulation. Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation. Infection. Timepoint: 2, 6 and 12 months later. Method of measurement: Physical examination. Bone length difference (up to 1 cm). Timepoint: 2, 6 and 12 months later. Method of measurement: Imaging evaluation and physical examination. Kerman University of Medical Sciences Approved 2017-12-17 Ethics committee of Kerman University of Medical Sciences Ibn Sina avenue; Jahad Blvd Kerman Kerman Iran (Islamic Republic of)