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IRCT20161101030637N3 IRCT 2021-11-04 Tabriz University of Medical Sciences TEN application for fixation of femoral trunk fractures in children Comparison of Titanium Elastic Nail (TEN) application for fixation of femoral trunk fractures in children with medial and lateral or just lateral portal 2021-11-21 anticipated 40 Complete https://irct.ir/trial/59433 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized (simple random) and single-blind clinical trial with parallel groups and in phase 2-3 that will be performed in Shohada Hospital in Tabriz.It should be noted that patients will be unaware of the type of groupings and randomly (dice roll was used for simple randomization. For patients in the first intervention group, odd numbers were considered and for patients in the second group, even numbers in Were considered) were divided into two groups , Blinding description: The patients studied in this study will be unaware of the type of grouping. 2-3 Pain. Intervention 1: Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will have surgery using Titanium Elastic Nail (TEN ) with lateral portal femoral trunk fracture and will be examined for one week from the release of pain intensity (three times a day). Intervention 2: Intervention group: Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will be operated on using TEN with two medial and lateral portals of their femoral bone fracture and for one week from the release of pain intensity (three times a day). ) Will be checked. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Hossein Aslani
Golshahr Ave, Shohada Hospital
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3336 3982 Dr.aslani73@yahoo.com Tabriz University of Medical Sciences scientific Hossein Aslani
Golshahr Ave, Shohada Hospital
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3336 3982 Dr.aslani73@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Unilateral or bilateral femoral trunk fracture Age range 5 to 16 years 5 years 16 years Both Patients with open femoral fractures G89.11 Acute pain due to trauma Treatment - Devices Treatment - Devices Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will have surgery using Titanium Elastic Nail (TEN ) with lateral portal femoral trunk fracture and will be examined for one week from the release of pain intensity (three times a day) Intervention group: Intervention group: Patients will be randomly placed in this group. After anesthesia, patients will be operated on using TEN with two medial and lateral portals of their femoral bone fracture and for one week from the release of pain intensity (three times a day). ) Will be checked. Pain. Timepoint: Three times a day for a week. Method of measurement: Visual scale of pain. Tabriz University of Medical Sciences Approved 2021-02-08 Ethics committee of Tabriz University of Medical Sciences Azadi Ave, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)