Evaluation of Accuracy and Cost-benefit (cost-effectivness) of Flouroscopy-guided Surgical Navigation in Distal Locking of Intramedulary Nails, Compared to the Conventional Method

Determining the accuracy and cost-effectiveness of using surgical guidance system with the help of fluoroscopic images is to place the distal locking screws of intramedullary nails in comparison with the conventional method.

The study will be performed in two groups of control and intervention group as double blinded and randomized through random numbers using Excel.The sample size in this study is 44 patients.

This clinical trial project is being carried out using the C-Guide system, a product of Parsis Company and performed in Shariati Hospital.This study is double blinded in which patients and the person in charge of data analysis are not aware.In Parsis surgical guidance system, images are analyzed and calibration processes are performed. The doctor will then be able to see the direction of his instrument on the images.

Patients with diaphysis fractures of the lower limb bones (femoral shaft or tibia) who are candidates for intramedullary nails (IMN) implantation. Exclusion criteria are as follows: Patients with open femoral or tibial shaft fractures, patients with small canal diameter, patients with bone canal obstruction, patients with a history of infection or active bone canal infection

The intervention group are patients who will be placed under the distal screw of the femoral or tibial concussion using the tracking method using surgical navigation or fluoroscopy. The control group includes patients in whom the implantation of the distal femoral or tibial conchae screw will be determined using the conventional method (Conventional C-arm).

Duration of screw installation Duration of operation Received radiation Total irradiation time Repeat shooting Number of drills Check the alignment of screws by imaging Duration of presence in the operating room Setup time

Patients will be randomly divided into control and intervention groups. The randomization of people will be done using the Permuted block randomization method with the random selection of the size of the blocks. Block randomization works by randomizing participants within blocks such that an equal number is assigned to each treatment. For example, given a block size of 4, there are six possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence. Furthermore, the block size must be divisible by the number of study groups. A disadvantage of block randomization is that the allocation of participants may be predictable and result in selection bias when the study groups are unmasked. That is, the treatment assignment that has so far occurred least often in the block likely will be the next chosen. Selection bias may be reduced by using random block sizes and keeping the investigator blind to the size of each block.

The blinding method in this study is double-blinded, in which the patients, the person responsible for randomization, and the person responsible for data analysis are not aware of the randomization setting of the study. Patients, the person responsible for randomization, and the person responsible for data analysis will only be aware of each person belonging to one of the group's A and B. They will not know which of the intervention or control groups each of the two groups, A and B, represents. Unlike the above people, the surgical team will know which of the intervention or control groups each of groups A and B belongs to.

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