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IRCT20220201053910N1 IRCT 2022-07-04 Karaj University of Medical Sciences Comparison of the result of intramedullary nailing by static and dynamic methods Comparison of the results of intramedullary nailing by static and dynamic methods in the erosion of femur and tibia shaft fractures. 2022-04-04 anticipated 102 Complete https://irct.ir/trial/61888 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after obtaining the informed consent of eligible individuals, individuals will be randomly divided into two groups: static and dynamic IMN. For this purpose, quadruple blocks (A, A, B, B) will be created and two groups of people will be formed in each block. These blocks are created randomly so that in each group, the number of people in the study stage is almost equal. Therefore, at each stage of the study, a block (allocation of four symbols inside the block is random and there are many blocks) is randomly selected and then people will assign to the relevant group in the order in which the block appears. (A group will be static IMN, B group will be dynamic IMN). N/A Fractures of the femoral shaft and tibia. Intervention 1: Intervention group: In this group, the static intramedullary nailing method will be used to fix the fracture in such a way that 3 to 4 screws are used at both ends to prevent vertical and rotational instability and bending. Intervention 2: Control group: In this group, the dynamic intramedullary nailing method will be used. In this way, a distal or proximal screw will be used that allows vertical pressure to control rotational instability and bending. Yes - There is a plan to make this available What will be shared: 1. Participants' data file will be shared after de-identifying individuals 2- The study protocol will be shared after the study 3- The statistical analysis map will be shared after the study 4- The informed consent form will be shared after the study 5- The statistical analysis map will be shared after the study 6. The clinical study report will be shared after the study 7. The codes used in the analysis will be shared after the study 8. The data classification system will be shared after the study When: The data access period will start 6 months after the publication of the study results To whom: All people working in the field of medical sciences will be allowed to access the data Conditions: Medical researchers can use the results of this study to conduct medical research, provided that they follow the principles of such research, such as non-copying. Where to obtain: Applicants can refer to the Clinical Research Development Unit of Madani Karaj Hospital at the address of Karaj, Mahan Blvd., Madani Hospital, Clinical Research Development Unit, to receive data. They can also email sedighiali112@gmail.com How to obtain: Applicants' request for data use will be reviewed by the Clinical Research Development Unit of the Civil Hospital and if this unit agrees, the data will be provided to the applicants. Comments:
public Ali Sedighi
Mahan blvd-Shahid madani hospital-Clinical Research Development Unit
Karaj Iran (Islamic Republic of) ۳۱۴۳۷۴۴۶۹۳ +98 26 3420 9028 sedighiali112@gmail.com Karaj University of Medical Sciences scientific Ali Sedigi
Mahan blvd-Shahid madani hospital-Clinical Research Development Unit
karaj Iran (Islamic Republic of) ۳۱۴۳۷۴۴۶۹۳ +98 26 3420 9028 sedighiali112@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) 18 to 80 years old Informed consent Having a fracture of the transverse or short inclination type The time to go to the hospital is less than two weeks after the fracture 18 years 80 years Both Open fractures Fractures with chopped parts Fractures associated with neurovascular injuries Fractures previously treated with IMN or periprosthetic fractures Diabetes Osteoporosis Treatment - Devices Treatment - Devices Intervention group: In this group, the static intramedullary nailing method will be used to fix the fracture in such a way that 3 to 4 screws are used at both ends to prevent vertical and rotational instability and bending. Control group: In this group, the dynamic intramedullary nailing method will be used. In this way, a distal or proximal screw will be used that allows vertical pressure to control rotational instability and bending. The final result of welding based on clinical and radiological evaluation (Harper criteria). Timepoint: Examinations will be done immediately after the surgery and then 8 weeks later and after that at intervals of 4 weeks to 6 months and the last visit and imaging will be done 9 to 21 months after the surgery. Method of measurement: Patients in both groups will be regularly examined and visited and photographed in two views and profile of the fracture site. Duration of complete welding. Timepoint: Examinations will be done immediately after the surgery and then 8 weeks later and after that at intervals of 4 weeks to 6 months and the last visit and imaging will be done 9 to 21 months after the surgery. Method of measurement: Patients in both groups will be regularly examined and visited and photographed in two views and profile of the fracture site. Karaj University of Medical Sciences Approved 2021-09-20 Ethics Committee of Alborz University of Medical Sciences mahan blvd-shahid madani hospital-Clinical Research Development Unit karaj Alborz Iran (Islamic Republic of)