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IRCT20210712051854N6 IRCT 2023-01-04 Tehran University of Medical Sciences Evaluation of the Effect of Surgical Navigation System on Diaphysis Fractures of Long Lower Limb Bones Evaluation of Accuracy and Cost-benefit (cost-effectivness) of Flouroscopy-guided Surgical Navigation in Distal Locking of Intramedulary Nails, Compared to the Conventional Method 2022-09-23 anticipated 44 Complete https://irct.ir/trial/63787 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Condition 1: Diaphysis fracture of the long bones of the lower extremities (Femoral Shaft). Condition 2: Diaphysis fracture of the long bones of the lower extremities (Tibia). Intervention 1: Intervention group: There are patients who will have a distal femoral or tibial concave screw implantation using surgical navigation or fluoroscopy. In this method, the navigation system is calibrated using radiographic images prepared before the operation. The navigation system is then calibrated with the patient in another step during the surgery. Distal IMN screw implantation in these patients is determined based on the location determined by the navigation system using imaging and anatomical landmarks of the patient. Intervention 2: Control group: Includes patients in whom the distal femoral or tibial IMN screw implantation will be determined using the conventional method (Conventional C-arm). In this method, for implanting the distal cone screw, an inter-operative radiograph will be taken from the bone by C-arm. Based on that, screw implantation is done. After each screw implantation, radiography of the bone will be done again by C-arm to ensure the correctness of the screw insertion. If the distal screw is not inserted correctly, this process will be repeated and will continue until the correctness of the distal screw is ensured. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Mohammad Hossein Nabian
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mh-nabian@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad Hossein Nabian
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mh-nabian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with diaphysis fractures of the long bones of the lower extremities (femoral shaft or tibia) who are candidates for intramedullary nails (IMN) implantation. 18 years 65 years Both 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 S72.3 S82.20 Fracture of shaft of femur Unspecified fracture of shaft of tibia Treatment - Surgery Treatment - Surgery Intervention group: There are patients who will have a distal femoral or tibial concave screw implantation using surgical navigation or fluoroscopy. In this method, the navigation system is calibrated using radiographic images prepared before the operation. The navigation system is then calibrated with the patient in another step during the surgery. Distal IMN screw implantation in these patients is determined based on the location determined by the navigation system using imaging and anatomical landmarks of the patient. Control group: Includes patients in whom the distal femoral or tibial IMN screw implantation will be determined using the conventional method (Conventional C-arm). In this method, for implanting the distal cone screw, an inter-operative radiograph will be taken from the bone by C-arm. Based on that, screw implantation is done. After each screw implantation, radiography of the bone will be done again by C-arm to ensure the correctness of the screw insertion. If the distal screw is not inserted correctly, this process will be repeated and will continue until the correctness of the distal screw is ensured. Screw insertion time. Timepoint: From the time of the start of the distal screw insertion until the end of it, during the operation. Method of measurement: Based on the time measured by the stopwatch. Duration of operation. Timepoint: From the time of the first fluoroscopic image of the organ to the time of preparing the fluoroscopic image for the final check. Method of measurement: Based on the time measured by the stopwatch. Radiation dose received. Timepoint: The amount of radiation received during the operation. Method of measurement: With the help of special radiology badges. X-ray radiation time. Timepoint: The duration of taking pictures with the C arm in each of the imaging methods. Method of measurement: Using the device's own settings. The number of repetitions of photography. Timepoint: The number of times of taking pictures with the arm in each of the imaging methods. Method of measurement: Using the device's own settings. The number of times to drill. Timepoint: The number of times to drill to find the screw path. Method of measurement: The number of times the guide contour leaves, which is mentioned in the patient's file and recorded by the resident during the procedure. Duration of operating room stay. Timepoint: The duration of the patient's presence in the operation room from the time of entry to the time of exit. Method of measurement: Based on the time measured by the stopwatch. Setup time. Timepoint: The time required to set up the operation equipment. Method of measurement: Based on the time measured by the stopwatch. Checking the alignment of screws by imaging. Timepoint: Checking the alignment of the distal screws with respect to the contour in the post-operative graph - the presence or absence of angulation and torsion. Method of measurement: Based on the opinion of an orthopedic and radiology specialist. Duration of anesthesia. Timepoint: From the time of induction of anesthesia until the time of complete return of consciousness. Method of measurement: Based on the time measured by the stopwatch. Checking the amount of union. Timepoint: In time intervals of 3, 6, 9 and 12 months after surgery. Method of measurement: Based on imaging data and the opinion of an orthopedic specialist. Parseh Intelligent Surgical Systems Co. Tehran University of Medical Sciences Parseh Intelligent Surgical Systems Co. Approved 2022-04-05 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)