S Endres1, A Badura. 1. Orthopedic and Traumatic Surgery Department, Elisabeth-Klinik, Bigge/Olsberg Sauerland Joint, endoprosthesis and spinal surgery center, Bigge, Heinrich-Sommerstrasse 4, 59939 Olsberg, Germany. s.endres@elisabeth-klinik.de
Abstract
OBJECTIVE: Currently, there are no clinical studies comparing different cement augmentation methods, and no clinical observational studies of a unipedicular approach. DESIGN, PATIENTS, INTERVENTIONS, MAIN OUTCOME MEASUREMENTS: The present study compared three commercially available vertebral augmentation systems: balloon kyphoplasty, vertebroplasty and shield kyphoplasty. The primary objective was to assess change in subjective severity of backache on a visual analog scale (VAS) and subjective improvement in quality of life on the Oswestry Disability Index (ODI), at a mean 6 months post-surgery. The secondary objective was to analyze current radiological imaging (X-ray, and in some cases CT) with regard to height restoration, cement distribution and leakage and recurrent fracture. RESULTS: Mean follow-up was 5.8 months. Mean preoperative Beck vertebral height index did not significantly differ between the three augmentation system groups (P>0.05). Comparing surgery time, fluoroscopy time and dose-area-product (cGy × cm(2)) showed a statistically significant difference (P<0.01) in favor of the vertebroplasty technique. Augmentation provided significant improvement in VAS pain assessment, but with no significant difference between augmentation systems. Results on the ODI were less pronounced, with significant improvement of 22% to 45%, but again without significant difference between augmentation systems. CONCLUSIONS: Overall, apart from mostly asymptomatic cement leakage, vertebroplasty could be considered as the surgical procedure of choice.
RCT Entities:
OBJECTIVE: Currently, there are no clinical studies comparing different cement augmentation methods, and no clinical observational studies of a unipedicular approach. DESIGN, PATIENTS, INTERVENTIONS, MAIN OUTCOME MEASUREMENTS: The present study compared three commercially available vertebral augmentation systems: balloon kyphoplasty, vertebroplasty and shield kyphoplasty. The primary objective was to assess change in subjective severity of backache on a visual analog scale (VAS) and subjective improvement in quality of life on the Oswestry Disability Index (ODI), at a mean 6 months post-surgery. The secondary objective was to analyze current radiological imaging (X-ray, and in some cases CT) with regard to height restoration, cement distribution and leakage and recurrent fracture. RESULTS: Mean follow-up was 5.8 months. Mean preoperative Beck vertebral height index did not significantly differ between the three augmentation system groups (P>0.05). Comparing surgery time, fluoroscopy time and dose-area-product (cGy × cm(2)) showed a statistically significant difference (P<0.01) in favor of the vertebroplasty technique. Augmentation provided significant improvement in VAS pain assessment, but with no significant difference between augmentation systems. Results on the ODI were less pronounced, with significant improvement of 22% to 45%, but again without significant difference between augmentation systems. CONCLUSIONS: Overall, apart from mostly asymptomatic cement leakage, vertebroplasty could be considered as the surgical procedure of choice.