Abstract

Synthetically manufactured bone substitute materials are widely used to fill cancellous bone defects in fracture treatment. By using these materials, complications occurring with the harvesting of autologous bone such as inflammation, hemorrhage and pain are prevented. Ideally, after osteointegration, the bone substitute resorbs, and complete restoration of bone architecture is achieved. Until now, clinical experience is limited to non-fully resorbable calcium phosphates, e. g., hydroxyapatite. Previous studies have revealed a fully resorbable pure calcium phosphate, which is applied in a paste form as a bone implant and results in complete resorption and biocompatibility. The purpose of this prospective, uncontrolled clinical study was to investigate the safety and performance of this new resorbable bone substitute material. In 107 patients, bone defects were filled with 1.0–27.5 g (median 5.45 g) of the bone substitute material. From 15 patients, biopsy samples for histological examination could be taken during secondary surgery, mostly when implants for osteosynthesis had to be removed. On clinical, radiologic and histological examination, the bone substitute material studied appeared safe and efficient for filling bone defects in fracture treatment, showing resorption and osseous integration during remodeling of bone. No clinical signs of allergic reactions or inflammation did occur. When using calcium phosphate bone cement, a second surgical procedure to harvest autologous bone is not necessary and complications at the donor site are avoided.

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