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.

Not Applicable

Recruiting

• Conditions: 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; M48.0

• Registration Number: IRCT20190126042496N2
• Lead Sponsor: eurofunctional Research Center of Shohada Tajrish Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 92

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.