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Study aim
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Evaluation of the effect of Vitamin D and Alendronate on pseudoarthrosis of the lumbosacral vertebrae in patients undergoing posterior lumbar fusion surgery
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Design
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This study is a clinical trial with a blind and randomized parallel group design. Among the patients diagnosed with lumbar disc herniation, spinal canal stenosis, lumbar Listis was selected by 75 neurosurgeons and divided into three groups of 25: fusion, fusion and andronate, fusion and vitamin D by blocking method (method of randomization).
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Settings and conduct
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This study among patients requiring laminectomy and lumbar vertebral fusion with the pedicure screw is performed up to 5 vertebral surfaces, referring to Imam Sari Hospital. The study is single blind and the radiologist interprets the patient's CT stereotype without knowing the clinical picture and how to be in the groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: lumbar discopathic patients, spinal canal stenosis, lumbar listhesis, Cr <1.2, patients between 20 and 65 years of age.
Non inclusion criteria: patients with traumatic lesions, neoplastic lesions, infectious lesions, surgical history, diabetes, disabling underlying problems and rheumatic diseases, patients with a history of osteoarthritis and vitamin D deficiency less than 10 units, patients with renal insufficiency and GFR below 40.
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Intervention groups
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Intervention group 1: Patients in the alendronate group were given 70 mg of oral alendronate once every 6 weeks after surgery for 6 months.
Intervention group 2: they received 50,000 units of vitamin D per month for six months.
Control group: Patients in the control group received routine treatment after surgery
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Main outcome variables
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Pain;
vertebral fusion