Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures

• Published in: Journal of neurointerventional surgery Vol. 8; no. 7; pp. 756 - 763
• Main Authors: Evans, Avery J, Kip, Kevin E, Brinjikji, Waleed, Layton, Kennith F, Jensen, Mary L, Gaughen, John R, Kallmes, David F
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.07.2016
• Subjects: Aged; Aged, 80 and over; Clinical trials; Comorbidity; Female; Follow-Up Studies; Fractures, Compression - epidemiology; Fractures, Compression - surgery; Humans; Kyphoplasty - methods; Male; Middle Aged; Mortality; Pain; Pain - epidemiology; Pain - surgery; Pain Measurement - methods; Questionnaires; Spinal Fractures - epidemiology; Spinal Fractures - surgery; Studies; Surgery; Treatment Outcome; Variables; Vertebroplasty - methods; Spine; Balloon
• ISSN: 1759-8478; 1759-8486
• DOI: 10.1136/neurintsurg-2015-011811

BackgroundWe present the results of a randomized controlled trial evaluating the efficacy of vertebroplasty versus kyphoplasty in treating vertebral body compression fractures.MethodsPatients with vertebral body compression fractures were randomly assigned to treatment with kyphoplasty or vertebroplasty. Primary endpoints were pain (0–10 scale) and disability assessed using the Roland–Morris Disability Questionnaire (RMDQ). Outcomes were assessed at 3 days, 1 month, 6 months, and 1 year following the procedure.Results115 subjects were enrolled in the trial with 59 (51.3%) randomly assigned to kyphoplasty and 56 (48.7%) assigned to vertebroplasty. Mean (SD) pain scores at baseline, 3 days, 30 days, and 1 year for kyphoplasty versus vertebroplasty were 7.4 (1.9) vs 7.9 (2.0), 4.1 (2.8) vs 3.7 (3.0), 3.4 (2.5) vs 3.6 (2.9), and 3.0 (2.8) vs 2.3 (2.6), respectively (p>0.05 at all time points). Mean (SD) RMDQ scores at baseline, 3 days, 30 days, 180 days, and 1 year were 17.3 (6.6) vs 16.3 (7.4), 11.8 (7.9) vs 10.9 (8.2), 8.6 (7.2) vs 8.8 (8.5), 7.9 (7.4) vs 7.3 (7.7), 7.5 (7.2) vs 6.7 (8.0), respectively (p>0.05 at all time points). For baseline to 12-month assessment in average pain and RMDQ scores, the standardized effect size between kyphoplasty and vertebroplasty was small at −0.36 (95% CI −1.02 to 0.31) and −0.04 (95% CI −1.68 to 1.60), respectively.ConclusionsOur study indicates that vertebroplasty and kyphoplasty appear to be equally effective in substantially reducing pain and disability in patients with vertebral body compression fractures.Trial registration numberNCT00279877.