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IRCT20201130049541N1 IRCT 2021-01-08 Esfahan University of Medical Sciences Results of L4-L5-S1 vertebral fusion treatment with L5-S1 in patients with L5-S1 spondylolisthesis Comparative study of L4-L5-S1 vertebral fusion treatment results with L5-S1 in patients with high grade L5-S1 spondylolisthesis 2020-11-21 anticipated 70 Complete https://irct.ir/trial/52793 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random function of Excel software based on patient file number will be used for randomization. Patients with spondylolisthesis were included in the Excel program based on the file number and were divided into case and control groups based on the random button. In total, there were two groups of 35 people. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 35 people in each group. As a result, sequences 1 to 2 should be repeated 35 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 35 for repeating the sequence. In this way, 70 units will be produced. N/A Spondylolisthesis. Intervention 1: The work of vertebral fixation in the first group using the device method in the vertebral body using pedicular screws is located on the surface of the vertebrae L4-L5-S1 and in fact, in this group three vertebrae are fixed . (L4-L5-S1 fixation surgery using pedicular screws with L5-S1 interbody fusion with autologous bone graft). Intervention 2: Control group: The device is placed in the vertebral body using pedicular screws on the surface of L5-S1 vertebrae and two lumbar vertebrae are fixed (L5-S1 fixation surgery using pedicular screws with L5-S1 interbody fusion With autologous bone graft). 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 There is no more information
public Majid Rezvani
Al-Zahra Educational and Medical Center, Sofeh Boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alzahra@mui.ac.ir Esfahan University of Medical Sciences scientific Majid Rezvani
Al-Zahra Educational and Medical Center, Sofeh Boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 alzahra@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) High grade L5-S1 spondylolisthesis Candidate for vertebral fusion operation with instrumentation Slip on the surface of a Vertebrae Patient consent to participate in the study Age less than 60 years no limit 60 years Both Patients with neurological defects and in need of emergency surgery Patients with a history of underlying diabetes and neuropathy Patients with a history of heart disease and preoperative anticoagulant use Patients who smoke and are addicted to drugs and alcohol Patients with metabolic bone diseases M43.1 Spondylolisthesis Treatment - Surgery Treatment - Surgery The work of vertebral fixation in the first group using the device method in the vertebral body using pedicular screws is located on the surface of the vertebrae L4-L5-S1 and in fact, in this group three vertebrae are fixed . (L4-L5-S1 fixation surgery using pedicular screws with L5-S1 interbody fusion with autologous bone graft) Control group: The device is placed in the vertebral body using pedicular screws on the surface of L5-S1 vertebrae and two lumbar vertebrae are fixed (L5-S1 fixation surgery using pedicular screws with L5-S1 interbody fusion With autologous bone graft) Intensity of pain. Timepoint: Before, one month, three months and six months after surgery. Method of measurement: Using the visual pain scale (VAS). Esfahan University of Medical Sciences Approved 2019-07-03 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)