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IRCT20190126042496N3 IRCT 2023-02-01 Neurofunctional Research Center of Shohada Tajrish Hospital Clinical and biomechanical outcomes following decompression of central canal and lateral recess simultaneous stenosis, with a focus on multilevel stenosis: A randomized comparison of microscopic bilateral laminotomy versus total laminectomy with posterior spinal fusion. Clinical and biomechanical comparison of microscopic bilateral laminotomy versus total laminectomy with posterior spinal fusion for decompression of central canal and lateral recess simultaneous stenosis, with a focus on multilevel stenosis: A prospective comparative study. 2023-01-25 anticipated 76 Complete https://irct.ir/trial/68186 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using a random number table (simple randomization), all patients who meet all the inclusion and exclusion criteria will be consecutively recruited from outpatient clinics and randomized into one of the study arms by the statistician. (1:1). N/A Patients with multilevel spinal canal stenosis, simultaneous stenosis of the central canal, and lateral recess.. Intervention 1: Intervention group 1(Group A): A group of patients with multi-level spinal canal stenosis, simultaneously stenosis of the central canal and lateral recess, who will be scheduled to undergo lumbar decompression surgery via microscopic bilateral laminotomy through a unilateral approach. Intervention 2: Intervention group 2 (Group B): A group of patients with multi-level spinal canal stenosis, simultaneously stenosis of the central canal and lateral recess, who will be scheduled to undergo lumbar decompression surgery via total laminectomy and partial medial facetectomy with posterior spinal fusion (bilaterally removal of the bony lamina ≥ 3 lamina, spinous processes, and interspinous intertransverse ligaments and medial facet, as well as posterior spinal fusion with pedicle screw fixation to prevent instability). 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) Between 30- and 75-year-old age Multi-level canal stenosis (≥ 3 levels) Stenosis of both the central canal (mild to moderate) and the lateral recess simultaneously. Failure of conservative therapy for radicular pain after six months. Radicular pain predominates over claudication(mild). 30 years 75 years Both Patients with severe stenosis of the central canal. Patients with severe neurogenic claudication suffer from leg pain that limits their ability to stand or walk. Extruded discs or those requiring discectomy Osteoporotic patients with a T score < -1.5 Previous spinal surgery history (laminotomy , laminectomy, or posterior spinal fusion ) Serious medical conditions such as congestive heart failure, cirrhosis, and other chronic diseases that preclude surgical procedures. Even though patients develop cardiac, renal, or pulmonary disorders during the study, they will be excluded. Current metabolic or rheumatologic and inflammatory disorders requiring corticosteroid consumption. Spinal deformity M48.0 Spinal stenosis Treatment - Surgery Treatment - Surgery Intervention group 1(Group A): A group of patients with multi-level spinal canal stenosis, simultaneously stenosis of the central canal and lateral recess, who will be scheduled to undergo lumbar decompression surgery via microscopic bilateral laminotomy through a unilateral approach. Intervention group 2 (Group B): A group of patients with multi-level spinal canal stenosis, simultaneously stenosis of the central canal and lateral recess, who will be scheduled to undergo lumbar decompression surgery via total laminectomy and partial medial facetectomy with posterior spinal fusion (bilaterally removal of the bony lamina ≥ 3 lamina, spinous processes, and interspinous intertransverse ligaments and medial facet, as well as posterior spinal fusion with pedicle screw fixation to prevent instability) VAS changes : Post-op versus pre-op VAS changes for leg pain and back pain. Timepoint: VAS scores will be measured before surgery, after 6-9 months, and after 18-24 months to determine the extent of pain relief. 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. Duration of hospitalization. Timepoint: Total number of hospital admission days. Method of measurement: Number of days staying in hospital with reference to medical records. Duration of operation. Timepoint: During surgery. Method of measurement: The number of hours it takes for the operation to be completed. Blood transfusion: The number of patients requiring blood transfusions. Timepoint: During surgery. Method of measurement: Based on doctor's diagnosis. Wound infection and discharge: Incidence of postoperative wound infection and discharge. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery ). Method of measurement: Based on doctor's diagnosis. Incidental durotomy: An accidental puncture or laceration of dura during a procedure. Timepoint: During surgery. Method of measurement: Based on doctor's diagnosis. Meningitis: Incidence of meningitis after surgery. Timepoint: Immediately after surgery until the end of the hospitalization period for each patient (up to 1 month after surgery). Method of measurement: Based on doctor's diagnosis. Revision surgery: The number of patients requiring revision surgery either due to technical issues or infections. Timepoint: Immediately after surgery until the end of the follow-up time. Method of measurement: Based on doctor's diagnosis. Root injury: Incidence of root injury during surgery. Timepoint: During surgery. Method of measurement: Based on doctor's diagnosis. Vacuum sign: Incidence of a collection of gas in the intervertebral disc space. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: Based on doctor's diagnosis via lateral plain radiographs. Adjacent segment disease (ASD): Degeneration of the mobile spinal segments between upper instrumented vertebra (UIV) and UIV+2 leading to spinal canal stenosis or discopathy . Timepoint: After 18-24 months follow-up. Method of measurement: Anteroposterior and lateral plain radiographs, and computed tomography (CT). Hypermobility: Increased range of motion between UIV and UIV+2. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: Flexion-extension radiographs. 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 follow-up time. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral radiograph. Sagittal vertical axis (SVA): The length of a horizontal line connecting the superior-posterior endplate of S1 to a vertical plumb line that drawn from the mid-point of the C7 vertebral body. This horizontal distance should be located within ± 5mm of the superior-posterior endplate of S1. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral spine radiographs. Pelvic incidence (PI): The angle is formed by the perpendicular line running from the midpoint of the sacral plate and a line connecting that point to the center of the bicoxofemoral axis that serves as the foundation for all other spinal curves. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral radiograph. Pelvic tilt (PT): The angle between the vertical axis and the line connecting the center of the coxofemoral axis to the midpoint of the S1 endplate. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral radiograph. Sacral slope (SS): The angle between the horizontal reference line and the line parallel to the superior plate of S1. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral radiograph. Lumbar lordosis (LL): The angle between the caudal endplate of L5 and the upper plane of the L1 lumbar vertebra. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The standing lateral radiograph. Pelvic incidence-lumbar lordosis mismatch (DPILL = PI-LL): A mismatch between pelvic incidence and lumbar lordosis strongly correlates with the sagittal balance and has become a key element in treating adult deformities. Timepoint: Immediately after surgery, after 6-9 months, and after 18-24 months follow-up. Method of measurement: The difference between pelvic incidence and lumbar lordosis. Neurofunctional Research Center of Shohada Tajrish Hospital Approved 2021-01-26 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)