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Study aim
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Comparison of laminectomy surgical methods with and without unilateral and bilateral lumbar pedicle screw fixation in young patients with spinal canal stenosis: a randomized clinical trial
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Design
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The clinical trial has 3 intervention groups. 81 patients are included in the study in parallel and without blinding. Random allocation is done based on permutation block design with 6 rows.
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Settings and conduct
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The surgery is performed by a surgeon at Valiasr Hospital in Qom province.
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Participants/Inclusion and exclusion criteria
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Patients with lumbar spine degeneration-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, as well as the presence of any previous surgery in the lumbar region, anemia, rheumatoid arthritis, osteoporosis, hypertension and uncontrolled diabetes, or the presence of any active infection in the body, consumption Anticoagulant 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 in other vertebrae, the presence of spondylolisthesis of any degree. In the beads, it is considered as the criteria of not entering the study.
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Intervention groups
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A: Laminectomy group without fixation
B: Laminectomy group with unilateral fixation
C: Laminectomy group with bilateral fixation
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Main outcome variables
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The variables investigated in this study include the clinical results (pain, quality of life, rehabilitation rate) of the patients, which are evaluated in the form of repeated measurements. Radiological results (fusion, disc recurrence, screw loosening) will also be evaluated 6 months after surgery.