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IRCT20171224038039N1 IRCT 2018-02-21 Zahedan University of Medical Sciences The study of the effect of Erythropoietin on Bone union The study of the effect of local Erythropoietin injection on Bone union in patients with Tibiofibular fracture 2018-01-20 anticipated 60 Complete https://irct.ir/trial/28420 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Easy and accessible randomization , considering the entry criteria for random assignment, in an envelope, the card will be placed with the letter A, B. then, after surgery, one of the colleagues is asked to select a card from the envelope, if A is selected, in the intervention group and if B is selected, will be placed in the control group, Blinding description: In spite of being informed about the study, the patient is not aware of the type of intervention involved, and the injection of Erythropoietin or placebo is done by an expert who is not involved in the outcome evaluation.Therefore, the outcome evaluator is unaware of the type of intervention. 2-3 Tibiofibular fracture. Intervention 1: Intervention group: 30 patients with Tibiofibular fracture that Erythropoietin injected at the fracture site. Intervention 2: Control group: 30 patients with Tibiofibular fracture that used the equivalent of placebo instead of Erythropoietin. 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 No more information.
public Asma Salehi sangani
Yas Complex, Dr Hesabi Sq
Zahedan Iran (Islamic Republic of) 9816746557 +98 51 5412 3454 a.salehi@zaums.ac.ir Zahedan University of Medical Sciences scientific Dr Arash Ghaffari
Khatam ol Anbia hospital, Rostam Sq
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3322 0501 Ghaffari.arash@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients with Tibiofibular fractures Patients with closed fracture type A,B Fractures caused by high energy of trauma Male gender Age between 18 to 40 years 18 years 40 years Male Patients with multiple lower injuries, metaphyseal and isolated tibial, pathologic, comminuted, osteoporotic and open fractures Patients under treatment with Steroids, Anticoagulants, Nonsteroidal Antiinflammatory drugs, Calcium Channel Blockers and Nicotine Underlying disease (Diabetes, Cardiovascular disease, etc.) S82.2 Fracture of shaft of tibia Treatment - Drugs Placebo Intervention group: 30 patients with Tibiofibular fracture that Erythropoietin injected at the fracture site. Control group: 30 patients with Tibiofibular fracture that used the equivalent of placebo instead of Erythropoietin. Duration of union: The duration between of sugery and time of Bone union was based on radiography and clinical examination that is defined based on month. Timepoint: At the beginning of the study and every 4 weeks after surgery. Method of measurement: Physical examination and radiographic imaging. Zahedan University of Medical Sciences Approved 2017-11-11 Ethics committee of Zahedan University of Medical Sciences Dr Hesabi sq, Pardis complex Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)