Abstract
A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1-2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% +/-8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% +/-16.1) and 8-week visit (mean 18.0 with CI95% +/-13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.