Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament™ SpineSupport) in vertebral compression fractures due to osteoporosis

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.

Bone Healing Using a Bi-Phasic Ceramic Bone Substitute Demonstrated in Human Vertebroplasty and with Histology in a Rabbit Cancellous Bone Defect Model

“…This investigation has shown that the bio-ceramic provides excellent pain relief comparable to PMMA 11 . This builds on the first reported clinical study with this material in Europe where 80% of 15 patients maintained pain relief over 18 months, and with no adjacent level fractures observed 15 . A secondary benefit of the material may be its ability to resorb and be replaced by living bone, compared to PMMA that may entail a risk of future device-related complications.…”

“…The radiocontrast was not visible on six and twelve month follow-up CT with improvement reported generally for PM-MA vertebroplasty 14 and was maintained at all time points within the 12 month follow-up period, with a tendency towards further improvement during the time period. In addition to pain relief, the general purpose of fracture treatment is to stabilize the fracture to allow bone healing in a correct position 15 . The fast and sustained pain relief demonstrated in this study indicates that this novel injectable biphasic ceramic bone substitute has sufficient mechanical strength to stabilize the compression fractures investigated and suggests healing of the vertebral fracture.…”

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome

“…The success of this material is based on immediate relief of pain and mechanical stabilization improving physical functions [3,8] as well as low cost [9]. However, clinical trial results have exposed a high complication rate in percutaneous vertebroplasty with PMMA range from 1 to 10 % [10,11], highlighting potential weaknesses such as thermal injury to surrounding tissues, potentially causing neurological damage, increasing fracture risk at adjacent levels due to the high inherent stiffness, and potential toxicity caused by the reactive material [2,4,9,12].…”

“…Percutaneous vertebral body augmentation, using a minimally invasive procedure, has been used, for decades, for vertebral fracture pain management in patients where conservative treatments, such as analgesics, bed rest, and bracing had failed [1][2][3].…”

The relevance of biomaterials to the prevention and treatment of osteoporosis

“…This material readily dissolves in vivo due to its comparatively high solubility (i.e. without the help of osteoclasts), but nevertheless has been proposed for bone augmentation [97,98] and bone void filling applications, for example for the filling of the "Kiva" device. Besides bone augmentation, ceramic cements have also been used for screw augmentation [99][100][101][102].…”