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IRCT20190126042496N2 IRCT 2023-01-19 Neurofunctional Research Center of Shohada Tajrish Hospital pedicle screw fixation with cement augmentation versus without in the treatment of spinal stenosis following posterior spinal fusion surgery, superiority according to bone mineral density: A three-arm randomized open clinical trial. Comparison of the efficacy of pedicle screw fixation with cement augmentation versus without in the treatment of spinal stenosis following posterior spinal fusion surgery, superiority according to bone mineral density: A three-arm randomized open clinical trial 2023-01-18 anticipated 92 Complete https://irct.ir/trial/68082 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Informed consent will be obtained from each participant before patient enrolment in the study. Patients who meet all the inclusion criteria and none of the exclusion criteria will be consecutively included and stratified into two groups according to T-score: Group I= non-osteoporotic (T-score >-1.5) and Group II= osteoporotic (T-score ≤-1.5). Afterward, the osteoporotic group will be randomized into one of the following study arms by the statistician according to a random allocation sequence by a random number table: Group II-A = osteoporosis without cement augmentation or Group II-B =osteoporosis+ cement augmentation. The intervention will be communicated to the patient by a surgeon. N/A Condition 1: Patients with spinal canal stenosis are candidates for posterior spinal fusion surgery. Condition 2: Osteoporosis is defined as a mean adjusted T-score of -1.5 or below. Intervention 1: Intervention group: (Group II-A) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation. Intervention 2: Intervention group: (Group II-B) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation with cement augmentation (0.8-1 cc of polymethylmethacrylate (PMMA) per screw, bilaterally into each vertebra with a viscosity slightly thinner than toothpaste. The screw is implanted into the vertebra prior to the complete solidification of the cement, and the rod is attached following solidification.). Intervention 3: Control group: A group of non-osteoporotic patients with T-score > -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation. 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 No more information
public Mohammadreza Shahmohammadi
Next to Taleghani hospital, Shahid Araabi St., Yaman St., Shahid Chamran highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mr_shahmohammadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammadreza Shahmohammadi
Next to Taleghani hospital, Shahid Araabi St., Yaman St.,Shahid Chamran highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mr_shahmohammadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) diagnosed with spinal stenosis by symptoms, signs, and imaging examinations advised for PSF surgery through pedicle screw fixation older than 40 years old 40 years no limit Both diagnosed with other vertebral disorders such as tumors or infections serious medical problems such as congestive heart failure and cirrhosis, calcium absorption disorder, hyperparathyroid disease diagnosed with spinal deformities including sagittal plane deformity and coronal imbalance M48.0 M81 Spinal stenosis Osteoporosis without current pathological fracture Treatment - Surgery Treatment - Surgery Treatment - Other Intervention group: (Group II-A) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation. Intervention group: (Group II-B) A group of osteoporotic patients with T-score ≤ -1.5 and spinal canal stenosis who will undergo pedicle screw fixation with cement augmentation (0.8-1 cc of polymethylmethacrylate (PMMA) per screw, bilaterally into each vertebra with a viscosity slightly thinner than toothpaste. The screw is implanted into the vertebra prior to the complete solidification of the cement, and the rod is attached following solidification.) Control group: A group of non-osteoporotic patients with T-score > -1.5 and spinal canal stenosis who will undergo pedicle screw fixation without cement augmentation. Changes in VAS score before and after posterior spinal fusion surgery. Timepoint: The VAS score will be measured before and after one year of surgery to determine the degree of pain reduction. Method of measurement: The patient's pain level is assessed on a horizontal line of 100 mm that its left end represents no pain, and the right end corresponds to the most severe pain that can be experienced. The patient is asked to mark the pain intensity they are experiencing currently. Proximal junctional kyphosis (PJK): A rise of over 20° in the Cobbs' angle between the lower endplate of the upper instrumented vertebra (UIV) and the upper endplates of two super-adjacent vertebrae between the immediate postoperative and after one year follow-up. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Through upright lateral radiographs. Proximal junctional vertebral fracture (PJVF): The fracture of UIV or UIV +1. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Adjacent segment disease (ASD):Degeneration of the mobile spinal segments above or below a fused spinal segment. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Screw fracture: Fracture of rod following pedicle screw fixation surgery. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Rod fracture: Fracture of rod following pedicle screw fixation surgery. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Screw loosening: The appearance of a radiolucent rim >1 mm (a halo) around at least one screw on radiography or CT scan. Timepoint: Immediately after surgery and after one year follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Neurofunctional Research Center of Shohada Tajrish Hospital Approved 2022-05-10 Institutional Research Ethics Committee - Shahid Beheshti University of Medical Sciences 3rth floor, Faculty of Medicine, next to Taleghani Hospital, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)