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. Spinal stenosis Osteoporosis without current pathological fracture
Conditions
Interventions
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. Int
Sponsors
Neurofunctional Research Center of Shohada Tajrish Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: diagnosed with spinal stenosis by symptoms, signs, and imaging examinations advised for PSF surgery through pedicle screw fixation older than 40 years old
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
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 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammadreza Shahmohammadi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed