Patients with multilevel spinal canal stenosis, simultaneous stenosis of the central canal, and lateral recess.. Spinal stenosis
Conditions
Interventions
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 und
Sponsors
Neurofunctional Research Center of Shohada Tajrish Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 diagnos | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Shahmohammadi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed