Bone Substitution and Augmentation in Trauma Surgery Using a Degradable Calcium Phosphate Bone Cement

Abstract

The purpose of this prospective, uncontrolled clinical multicenter study was to prove the safety and performance of a new resorbable bone substitute material. The injectable microcrystalline hydroxyapatite cement-like material (α-BSM/Biobon®) hardens in an endothermal reaction at about 37 °C after implantation. Its chemical composition and the crystalline structure appear essentially identical to the calcium phosphate component of natural bone and due to this it is highly biocompatible. This bone substitute material was used in cases of operative treatment of mainly cancellous bone defects in 49 patients. 51 bone defects in 49 patients (age 22-73) were filled with 0.5 up to 20 g (median 5.5 g) of bone cement (α-BSM/Biobon®). 39 trauma defects were treated (calcanear fractures 12, tibial head fractures 10, distal radial fractures 10, others 7, 2 patients with 2 implantation sites). In 12 patients bone defects originated from benign tumors, bone cysts and defects of donor sites after bone transplantation were filled by calcium phosphate cement. The radiological and clinical follow-up was performed after 1, 3, 6 and 12 months. This bone substitute material was easy to prepare and easy to apply, manually or by syringe, in the operating theatre. After hardening, the calcium phosphate bone substitute material could withstand moderate compression forces associated with normal treatment of patients with properly reduced and stabilized bone fracture defects. There were no signs of fracture dislocation or complications related to the calcium phosphate implant. Except for one soft tissue infection primary wound healing was observed in all cases. The radiographs showed indistinct outlines of the calcium phosphate bone substitute material with increasing time as a sign of osseous integration and resorption. All patients recovered in a way which can be expected in these type of fractures or bone defects treated by autologous bone grafting. This calcium phosphate bone substitute material appeared safe and osteoconductive and was suitable for filling bone defects and bone cavities for selected clinical cases showing slow resorption and a rapid osseous integration.

Key words

Hydroxyapatite - tricalcium phosphate - bone cement - bone defect

References

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1 Biobon® is a trade mark name for calcium phosphate bone substitute of Merck Biomaterial GmbH, Darmstadt.