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IRCT20230222057496N6 IRCT 2025-09-25 Hamedan University of Medical Sciences Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine Comparison of cranial and caudal pedicle screw-selective unilateral cemented versus fully reinforced pedicle screws in the lumbar spine of patients with osteoporosis a prospective randomized clinical trial. 2025-10-22 anticipated 90 Complete https://irct.ir/trial/86021 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be enrolled using a convenience sampling method and will be divided into three groups A, B, and C based on a randomized block design with rows of six. Group A includes patients who will undergo spinal fixation surgery with full reinforcement of pedicle screws with bone cement. Group B includes patients who will undergo spinal fixation surgery without cement reinforcement, and group C includes patients in whose surgical technique the caudal and cranial pedicle screws will be reinforced unilaterally with bone cement and the other screws will be placed without cement reinforcement. N/A Degenerative disease of the lumbar spine. Intervention 1: Intervention group: Pedicle Screw Fixation + Cement: Initially, a midline incision was made in the posterior region, and then a decompression procedure including bilateral partial facetectomy was performed for all patients. Before screw placement, two entry holes were made in the vertebral pedicles at the L3-L5 level using an awl, and then a 3-mm guide hole was created with a Lenke probe. The selected screws had a solid core and were made of titanium alloy. Fluoroscopic radiography using a C-arm was used to determine the exact placement of the screws. In the created hole, 2 ml of bone cement with special fillers was injected into each screw (all screws were inserted with cement reinforcement). In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were placed precisely according to the method described by Weinstein et al. (17). Intervention 2: Intervention group: Pedicle Screw Fixation - Cement: Initially, a posterior incision was made for all patients, followed by decompression including bilateral partial facetectomy. Then, pedicle screws with a length of 40 to 50 mm and an external diameter of 6 to 6.5 mm were placed bilaterally at the L3-L5 level in the designated areas under fluoroscopic guidance. This process was performed without injecting cement into the bilateral guide holes. In the final stage, the screws were connected to each other using a 5.5 mm diameter rod, and the fixation process was fully completed by adjusting the vertebrae. Intervention 3: Intervention group: Pedicle Screw Fixation ± Cement: According to the previous surgical technique, after partial facetectomy, 2 ml of high-viscosity cement was unilaterally injected into the created cavity of the upper and lower screws along with bone fillers. In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were precisely placed. The other screws were inserted without cement reinforcement. Finally, the rods and nuts were properly assembled and the structure was stabilized. The cement around the nuts was evaluated by CT scan within 72 hours after surgery and was evaluated according to the classification of Yeom et al. Yes - There is a plan to make this available What will be shared: Information from all participants without personal information will be published in the form of tables as a general conclusion. When: After the sampling is completed and the final data analysis is performed To whom: General public Conditions: In order to increase public awareness of unilateral and bilateral surgical methods, and improve the clinical skills of surgeons in choosing the most effective surgical method. Where to obtain: Trusted databases How to obtain: Visit the desired database and use keywords to access the article. Comments:
public Ali Mehrafshan
Jomhuri Street-Vali Asr Hospital
Qom Iran (Islamic Republic of) 371725219 +98 25 3861 9252 Alimehrafshan2@gmail.com Ghoum University of Medical Sciences scientific Ali mehrafshan
Jomhuri Street-Vali Asr Hospital
Qom Iran (Islamic Republic of) 371725219 +98 25 3861 9252 Alimehrafshan2@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Age over 50 years T-score < - 2.5 BMI between 30-20 The patient is free of uncontrolled chronic diseases such as diabetes or cardiovascular disorders. 50 years no limit Both Previous surgery in the lumbar region Degenerative disorders in other vertebrae Taking opioids to relieve pain Unwillingness to follow up after surgery G32 Other degenerative disorders of nervous system in diseases classified elsewhere Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: Pedicle Screw Fixation + Cement: Initially, a midline incision was made in the posterior region, and then a decompression procedure including bilateral partial facetectomy was performed for all patients. Before screw placement, two entry holes were made in the vertebral pedicles at the L3-L5 level using an awl, and then a 3-mm guide hole was created with a Lenke probe. The selected screws had a solid core and were made of titanium alloy. Fluoroscopic radiography using a C-arm was used to determine the exact placement of the screws. In the created hole, 2 ml of bone cement with special fillers was injected into each screw (all screws were inserted with cement reinforcement). In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were placed precisely according to the method described by Weinstein et al. (17). Intervention group: Pedicle Screw Fixation - Cement: Initially, a posterior incision was made for all patients, followed by decompression including bilateral partial facetectomy. Then, pedicle screws with a length of 40 to 50 mm and an external diameter of 6 to 6.5 mm were placed bilaterally at the L3-L5 level in the designated areas under fluoroscopic guidance. This process was performed without injecting cement into the bilateral guide holes. In the final stage, the screws were connected to each other using a 5.5 mm diameter rod, and the fixation process was fully completed by adjusting the vertebrae. Intervention group: Pedicle Screw Fixation ± Cement: According to the previous surgical technique, after partial facetectomy, 2 ml of high-viscosity cement was unilaterally injected into the created cavity of the upper and lower screws along with bone fillers. In the next step, screws with a length of 40 to 50 mm and an outer diameter of 6 to 6.5 mm were precisely placed. The other screws were inserted without cement reinforcement. Finally, the rods and nuts were properly assembled and the structure was stabilized. The cement around the nuts was evaluated by CT scan within 72 hours after surgery and was evaluated according to the classification of Yeom et al. Bleeding. Timepoint: During surgery. Method of measurement: Blood, suction bottle and blood gases. Time Surgery. Timepoint: During Surgery. Method of measurement: Smartwatch. Pain. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Visual analog scale. Infection. Timepoint: After surgery. Method of measurement: Southampton Scale. Functional Disability. Timepoint: Before surgery and in the first month after surgery. Method of measurement: Functional Disability Questionnaire. Pain. Timepoint: 12th month after surgery. Method of measurement: Visual analog scale. Functional Disability. Timepoint: 12th month after surgery. Method of measurement: Functional Disability Questionnaire. Fution. Timepoint: 12th month after surgery. Method of measurement: Radiographic image. Loosening of the screw. Timepoint: 12th month after surgery. Method of measurement: Radiographic image. Adjacent segment damage. Timepoint: 12th month after surgery. Method of measurement: Radiographic image. Hamedan University of Medical Sciences Approved 2025-09-07 Ethics committee of Hamadan University of Medical Sciences Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor Hamadan Hamadan Iran (Islamic Republic of)