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IRCT20210712051854N4 IRCT 2022-11-05 Parseh Intelligent Surgical Systems Co. Evaluation of the effect of surgical guidance system in spine surgery Evaluation of accuracy and cost-effectiveness of using surgical guidance system with the help of fluoroscopic images in placing pedicle screws in comparison with conventional methods 2022-09-23 anticipated 44 Complete https://irct.ir/trial/63946 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, Blinding description: The blinding method in this study is double blinded in which patients and the person responsible for data analysis are not aware of the randomization setting of the study. N/A Spine surgeries. Intervention 1: Intervention group: There are patients who will have pedicle screw implantation using Surgical navigation or Fluoroscopy. Intervention 2: Control group: Includes patients in whom the placement of the pedicle screw will be determined using the conventional method (conventional C-arm). Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: After printing the results as an article To whom: Researchers working in academic institutions Conditions: For further research purposes and analysis Where to obtain: In order to receive the data, it is necessary to refer to the scientific accountant or the corresponding author of the article How to obtain: An official letter or e-mail Comments:
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 should have spinal surgery and a pedicle screw implanted in the neck surface. Patients should have spinal surgery and a pedicle screw implanted in the chest surfaces. Patients should have spinal surgery and pedicle screw implantation in the lumbar surfaces. Patients should have spinal surgery and pedicle screw implantation at the sacral surfaces. 18 years 65 years Both Dissatisfaction with participating in the study Age under 18 years Treatment - Other Treatment - Other Intervention group: There are patients who will have pedicle screw implantation using Surgical navigation or Fluoroscopy. Control group: Includes patients in whom the placement of the pedicle screw will be determined using the conventional method (conventional C-arm). 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. 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. Tehran University of Medical Sciences Parseh Intelligent Surgical Systems Co. Tehran University of Medical Sciences Approved 2022-02-12 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)