tude comparative de la kyphoplastie par syst猫me Shield par rapport 脿 la vert茅broplastie et la kyphoplastie au ballonnet dans les fractures thoracolombaires ost茅oporotiques聽: une 茅tude prospective randomis茅e
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摘要

Summary

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 postsurgery. 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*cm2) 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 the surgical procedure of choice.

Level of evidence II

Low-powered prospective randomized trial.

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