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Comparison of the effectiveness of unilateral and bilateral lumbar pedicle screw fixation in elderly people

Comparison of the effectiveness of unilateral and bilateral lumbar pedicle screw fixation in elderly people with spinal stenosis: A prospective randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230222057496N5
Enrollment
90
Registered
2025-09-25
Start date
2025-10-22
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative disease of the lumbar spine. Other degenerative of the nervous system

Interventions

Intervention 1: Intervention group: There are patients whose treatment protocol is laminectomy (bilateral) without fixation. Intervention 2: Intervention group: There are patients whose treatment prot

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Age range over 50 years Lumbar spinal stenosis observed in the L3-L5 range on magnetic resonance imaging Use of conservative treatments for at least 6 weeks, BMI between 20-30 Visual analog scale above 7 before surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bleeding. Timepoint: during surgery. Method of measurement: Bottle suction and blood gases.;Time surgery. Timepoint: During surgery. Method of measurement: Smartwatch.

Secondary

MeasureTime frame
Pain. Timepoint: The first, third, and sixth months after surgery. Method of measurement: Visual analog scale.;Functional disability. Timepoint: The first, third, and sixth months after surgery. Method of measurement: Functional Disability Questionnaire.;Quality of life. Timepoint: The first, third, and sixth months after surgery. Method of measurement: SF-36 questionnaire.;Fution. Timepoint: 6 months after surgery. Method of measurement: Radiographic images.;Spondylolisthesis. Timepoint: 6 months after surgery. Method of measurement: Radiographic images.;Recurrence of disc and adjacent segment damage. Timepoint: 6 months after surgery. Method of measurement: Radiographic images.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Mehrafshan

Hamedan University of Medical Sciences

Alimehrafshan2@gmail.com+98 25 3861 9252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026