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I read with interest the manuscript “Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures” published in the Journal of NeuroInterventional Surgery.1 Although the authors make some valid scientific points in the article, the study has significant shortcomings that should be recognized.
One of the critical issues with this paper is the lack of inclusion of the statistical power calculations necessary to prove or disprove the null hypothesis. The authors use pain and function (Roland–Morris Disability Questionnaire) as primary endpoints for comparing vertebroplasty (VP) and kyphoplasty (KP). The formula described here is typical for calculating sample size in each group. If the desired power is 80% and the level of statistical significance is 1.96, we can use the value of 1–2.5 as a statistical difference threshold in pain after treatment according to the largest VP versus KP manuscript published to date along with other standard references of measurement.2–4 If the standard method of calculation for each group is used to detect a standard difference in pain there would need to be a minimum of 512 patients in each group—that is, 1024 patients in total. The KAVIAR study calculated that a total of 1234 patients would be necessary to determine an 8.7% difference in their primary endpoint—subsequent radiographic fractures. This patient …
Correction notice This article has been corrected since it published Online First. The competing interests statement has been amended.
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Competing interests Medtronic – advisory board, consultant, research funding; Amendia – consultant; Spineology – consultant, stock owner; Dfine – consultant; Osseon – consultant; Lilly – advisory board, consultant; Xten – consultant; Smith & Nephew – consultant; Ascendx Spine – consultant, research funding; Vertiflex – consultant; Synthes – consultant; Depuy – consultant; Johnson & Johnson – consultant; Orthovita – consultant, research funding; Vitacare – consultant, research funding; Ortho Kinematics – consultant, research funding; Alphatech Spine – consultant, research funding; Dfine – consultant, research funding; Advanced Technologies and Regenerative Medicine – research funding; Algea-Globus – consultant; Benvenue – consultant, research funding, medical director, stock owner; Bone Support – consultant, research funding; Convatec – advisory board, consultant; Integral Spine Solutions – advisory board, consultant; Spinal Ventures – consultant; Medical Metrics – consultant, research funding; Zyga – consultant, research funding; Liventa – consultant, research funding; Vexim – consultant, board member; Mesoblast – research funding.
Provenance and peer review Not commissioned; internally peer reviewed.