2011
DOI: 10.17816/vto20111843-10
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Minimum Invasive Stabilizing and Decompressive-Stabilizing Methods of Surgical Treatment for Degenerative-Dystrophic Lesions of Spine

Abstract: Results of randomized prospective study with participation of 94 patients aged from 20 to 70 years with monosegmental lumbar spine lesions are presented. Minimum invasive surgical interventions were performed in 55 patients from the main group. Control group consisted of 39 patients in whom decompressive-stabilizing operations via conventional posteromedian approach with skeletization of posterior segments of vertebral column were performed. Average size of operative wound in open interventions more than 10 ti… Show more

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“…Under non-inferiority design, the sample size was calculated for ODI difference between the values before intervention and 3 months after. Assuming mean of ODI difference is 39 and SD of ODI difference is 19.3 in both groups (based on our own published data (18.8 at 1-year follow-up, 27 19.3 at 3-month follow-up 28 ), the noninferiority margin δ=12, for a one-sided Mann-Whitney U test with a critical significance p=0.05 and test power is 80%, it is enough to allocate 38 patients. Considering the 20% loss, the total sample size will be 96 patients, 48 in each group.…”
Section: Sample Sizementioning
confidence: 99%
“…Under non-inferiority design, the sample size was calculated for ODI difference between the values before intervention and 3 months after. Assuming mean of ODI difference is 39 and SD of ODI difference is 19.3 in both groups (based on our own published data (18.8 at 1-year follow-up, 27 19.3 at 3-month follow-up 28 ), the noninferiority margin δ=12, for a one-sided Mann-Whitney U test with a critical significance p=0.05 and test power is 80%, it is enough to allocate 38 patients. Considering the 20% loss, the total sample size will be 96 patients, 48 in each group.…”
Section: Sample Sizementioning
confidence: 99%