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IRCT20230222057496N3 IRCT 2024-02-26 Hamedan University of Medical Sciences Comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation A comparative study of lumbar spine stabilization with 2-stage surgery and cement augmentation in osteoporosis patients: a randomized clinical trial 2022-11-22 anticipated 66 Complete https://irct.ir/trial/75143 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly entered into the study and will be divided into 2 groups A and B based on permutation block design with rows of 4. Group A are patients in whom bone cement will be used as part of their treatment protocol to reinforce the pedicle screw. Group B are patients whose treatment protocol is 2-stage surgery. N/A Lumbar spine degeneration. Intervention 1: Intervention group first; First intervention group: Lumbar spine stabilization surgery in one step along with pedicle screw reinforcement with bone cement. Intervention 2: Intervention group second: Spine stabilization surgery is performed in 2 stages, first pedicle screws are installed and 6 months after that, the rod and other attachments are installed. 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 further information
public Parisa hajilo
5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamedan
Hmadan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3131 0000 Parisahajilo73@gmail.com Hamedan University of Medical Sciences scientific Dr ali mehrafshan
Tawheed Square, Koche 9, Tawheed Physiotherapy Building, 2nd floor
Qom Iran (Islamic Republic of) 3717195170 +98 25 3861 9252 Parisahajilo73@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Osteoporosis patients with pre-surgery bone density in the range (T-Score->2.5) age range over 50 years body mass index between 20-30 with degenerative lumbar spine complications at L1-S1 level is 50 years no limit Both Patients who could not be reached or lived outside the province pationts did not want to enter the study The presence of other pathological factors (cysts or tumors) discopathy in other vertebrae performing any re-surgery during the past year using narcotics or narcotic drugs and smoking suffering from underlying diseases affecting Osteoporosis (rheumatoid arthritis, thyroid disorders...) G30-G32 Other degenerative diseases of the nervous system Treatment - Surgery Treatment - Surgery Intervention group first; First intervention group: Lumbar spine stabilization surgery in one step along with pedicle screw reinforcement with bone cement Intervention group second: Spine stabilization surgery is performed in 2 stages, first pedicle screws are installed and 6 months after that, the rod and other attachments are installed. Pain. Timepoint: Before surgery - one month after surgery. Method of measurement: VAS visual analog scale. Disability of patients. Timepoint: Before surgery - one month after surgery. Method of measurement: Oswestry Disability Index (ODI). Fution. Timepoint: 12 months after surgery. Method of measurement: BSF classification scale. Pedicle Screw loosing. Timepoint: 12 months after surgery. Method of measurement: Dynamic radiography and CT scan images. Hamedan University of Medical Sciences Approved 2024-01-27 Ethics Committee of Hamadan University of Medical Sciences 5th floor, Shahid Fahmideh Blvd., University of Medical Sciences, Central Headquarters, Research Square Hamadan Hamadan Iran (Islamic Republic of)