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

Not Applicable

Recruiting

• Conditions: umbar spine degenerative disease.; Other degenerative diseases of the nervous system; G30-G32

• Registration Number: IRCT20230222057496N2
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 81

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.