Calcibon® Granules

Calcibon® Granules are synthetic, biodegradable, porous granules intended for the use as bone substitute material. The granules are based on the well known Calcibon®. The starting material for the Calcibon®Granules production is synthesised from calcium and phosphate salts. By a special production method porous granules are produced. The granules are intended for filling of metaphyseal, cancellous bone defects.

Features

synthetic, osteoconductive, porous, calcium phosphate based granules
micro and macro pores
granule size 2-4 mm
augmentation with autologous bone graft, bone marrow aspirate, blood or PRP (GPS™ System)
biodegradation by cellular mediated processes

The Material

Calcibon®Granules consist of microcrystalline, carbonated, calcium deficient hydroxyapatite. The crystalline structure and the chemical composition of the granules is almost equivalent to those of the calcium phosphate component of natural bone.

The macro pores (150-550 µm) allow cells, e.g. osteoclasts and osteoblasts, to migrate into the granules. The macro pores are separated from each other by thin walls, which in turn consist of a microporous network. These micro pores (<10 µm) allow the cells involved in the remodelling process to be supplied with nutrients.

Because of the porous structure the compressive strength of the granules is 4-7 MPa.

The Indications

Calcibon®Granules are intended for filling and reconstruction of large, aseptic, metaphyseal, cancellous bone defects. These bone defects might be caused by trauma or other genesis, e.g. a benign tumour, from surgery or congenital. The granules can be applied directly or be augmented with other materials:

PRP (platelet rich plasma) from the GPS™ System
bone marrow aspirate
blood
autologous bone graft

Calcibon®Granules are a one-time implant which stays in place until they will be biodegraded.

Depending on the indication accurate repositioning as well as fixation and stabilisation should be performed as if using autologous bone graft.

Well-tried indications for Calcibon®Granules:

reconstruction of the acetabulum after aseptic loosening
bone cysts
distal radius fractures
filling material for cages

Current papers:

(1) Driessens FCM, Boltong MG, Wenz R. Calcium phosphate bone cements: State of the art 2000. 12th Conference of the European Society of Biomechanics, Dublin, Ireland, 27-30th August 2000

(2) Linhart W, Briem D, Peters A, Lehmann W, Windolf J, Rueger JM. Resorbierbare Kalziumphosphatzemente. Trauma Berufskrankheit 2004; online: 29. Oktober

(3) Ooms EM, Wolke JGC, van de Heuvel MT, Jeschke B, Jansen JA. Histological evaluation of the bone response to calcium phosphate implanted in cortical bone. Biomaterials 2003; 24: 989-1000

(4) Schnettler R, Stahl JP, Alt V, Pavlidis T, Dingeldein E, Wenisch S. Calcium phosphate-based bone substitutes. Eur J Trauma 2004; 30: 219-229

For further information about the products, health care professionals should contact their Biomet Europe representative or local office. Patients with questions about products are advised to contact their local surgeon.