Osteoporotic vertebral compression fractures augmentation by injectable partly resorbable ceramic bone substitute (Cerament™|SPINE SUPPORT): a prospective nonrandomized study.

INTRODUCTION

The aim of this study is to evaluate the long-term stabilizing-healing effectiveness and influence on adjacent intact vertebral bodies of a new injectable partly resorbable calcium sulfate (60 wt.%)/hydroxyapatite (40 wt.%) bone substitute employed in vertebral augmentation of osteoporotic collapses.

METHODS

From April 2009 to April 2011, 80 patients underwent vertebral augmentation. Patients enrolling criteria were age >20 years and symptomatic osteoporotic vertebral collapse from low-energy trauma encompassed between levels T5 to L5. Preoperative and postoperative imaging studies consisted of computed tomography, plain X-ray, dual X-ray absorptiometry scanning, and magnetic resonance. Pain intensity has been evaluated by an 11-point visual analog scale (VAS) and physical and quality of life compromise assessments have been evaluated by Oswestry Disability Questionnaire (ODI). All procedures have been performed fluoroscopically guided by left unilateral approach under local anesthesia and mild sedation.

RESULTS

VAS-based pain trend over the 12-month follow-up has shown a statistically significant (p < 0.001) decrease, starting from 7.68 (SD 1.83) preoperatively with an immediate first day decrease at 3.51 (SD 2.16) and 0.96 (SD 0.93) at 12 months. ODI score dropped significantly from 54.78% to 20.12% at 6 months. No device-related complication has been reported. In no case a new incidental adjacent fracture has been reported.

CONCLUSION

Data show how this injectable partly resorbable ceramic cement could be a nontoxic and lower stiffness alternative to polymethylmethacrylate for immediate and long-term stabilization of osteoporotic collapsed vertebral bodies.