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Comparison study of surgical methods of laminectomy with and without unilateral and bilateral lumbar pedicle screw fixation

Comparison study of surgical methods of laminectomy with and without unilateral and bilateral lumbar pedicle screw fixation in young patients with spinal canal stenosis: a randomized clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230222057496N2
Enrollment
81
Registered
2023-12-06
Start date
2023-12-11
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Lumbar spine degenerative disease. Other degenerative diseases of the nervous system

Interventions

Intervention 1: Intervention group: Laminectomy with unilateral fixation. Intervention 2: Intervention group: Laminectomy with bilateral fixation.

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 40 Years

Inclusion criteria

Inclusion criteria: Age range less than 40 years observation of lumbar spinal stenosis in the L3-L5 range in magnetic imaging (a discopathy level at the level of L3-L4 or L4-L5 vertebrae) use of conservative treatments for at least 6 weeks BMI between 20-30 visual analog scale above 7 before surgery

Exclusion criteria

Exclusion criteria: The presence of any previous surgery in the lumbar region Rheumatoid arthritis, osteoporosis, high blood pressure and uncontrolled diabetes, or the presence of any active infection in the body Taking anti-coagulant drugs or any type of drug effective on wound healing, long-term use of opioids, smoking and other narcotic drugs before surgery to reduce pain The presence of any pathological or discopathy material in other vertebrae

Design outcomes

Primary

MeasureTime frame
Bleeding. Timepoint: during surgery. Method of measurement: Accumulated blood in the suction bottle and blood gases.;Time of surgery. Timepoint: during surgery. Method of measurement: stopwatch.;Pain. Timepoint: During surgery and 6 months after surgery. Method of measurement: Visual Analogue Scale.;Rehabilitation. Timepoint: Before surgery. Method of measurement: Oswestry Disability Index.;Quality of Life. Timepoint: Before surgery. Method of measurement: Varusherbon 36-item quality of life questionnaire.;Wound Healing. Timepoint: Up to one month after surgery. Method of measurement: Southampton Wound Healing Assessment Scale.

Secondary

MeasureTime frame
Rehabilitation. Timepoint: 6 months after surgery. Method of measurement: Oswestry Disability Index.;Quality of Life. Timepoint: 6 months after surgery. Method of measurement: Varusherbon 36-item quality of life questionnaire.;Pain. Timepoint: 3 and 6 months after surgery. Method of measurement: ????? ?????? ??????.;Fution. Timepoint: 6 months after surgery. Method of measurement: Brantigan Steffee-Fraser scale.;Adjacent segment disease. Timepoint: 6 months after surgery. Method of measurement: Prrmann grading system.;Spondylolisthesis. Timepoint: 6 months after surgery. Method of measurement: meyerding classification.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa hajilo

Hamedan University of Medical Sciences

Parisahajilo73@gmail.com+98 25 3861 9252

Outcome results

None listed

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