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

Introduction: This study aimed to evaluate 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. Patient enrolment criteria are as follows: age more than 20 years; symptomatic osteoporotic vertebral compression fracture from low energy trauma encompassing level T5 to L1 and classified as A1.1 to A1.2 according to the AO classification system; vertebral height compression within 0-75% compared to the posterior (dorsal) wall; client history confirming the age of the compression fracture to be within at least 4 weeks; and patients who are able to understand the procedure and participate in the study. 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 12-month follow-up has shown a statistical 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. The ODI score dropped significantly from 54.78% to 20.12% at 6 months. None 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.