Calcibon®

Calcibon® is a synthetic, biodegradable, calcium phosphate based bone substitute. It is intended for filling of metaphyseal, cancellous bone defects. The material is mixed during the operation from a liquid and a powder part. The resulting paste is applied directly and hardens at body temperature. The chemical composition and crystalline structure of the cured material mimic the mineral part of natural bone.

Features

high compressive strength (up to 60 MPa)
synthetic, osteoconductive, calcium phosphate based bone substitute
malleable paste, hardens in-situ
setting reaction at body temperature without heat generation
application in blood-filled defects possible
biodegradation by cellular mediated processes

The Material

The mixing of Calcibon® liquid and Calcibon® powder results in a paste that has the ideal consistency for easy application in bone defects.

The Calcibon® powder is synthesised from calcium and phosphate salts. It consists of alpha-tri-calcium-phosphate, calcium-hydrogen-phosphate, calcium-carbonate, and precipitated hydroxyapatite. The Calcibon® liquid is an aqueous di-sodium-hydrogen-phosphate solution. It initiates the curing process within the paste. The paste hardens at body temperature without heat generation. The final material is a microcrystalline, carbonated, calcium deficient hydroxyapatite. The crystalline structure and the chemical composition of the cured material is almost equivalent to those of the calcium phosphate component of natural bone. The compressive strength of the material increases during the hardening process. After 6 hours it is comparable to cancellous bone. The final compressive strength is reached after 3 days and is up to 60 MPa.

The Indications
Calcibon® is intended for the filling and reconstruction of 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. Calcibon® is a one-time implant which stays in place until it 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®:

tibial head fractures
distal radius fractures
calcaneus fractures

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) Hillmeier J, Meeder PJ, Nöldge G, Kasperk C. Minimally invasive reduction and internal stabilization of osteoporotic vertebral body fractures (Balloon Kyphoplasty). Operat Orthop Traumatol 2003; 15: 343-362

(3) Hillmeier J, Meeder PJ, Nöldge G, Kock HJ, Da Fonseca K, Kasperk C. Augmentation von Wirbelkörperfrakturen mit einem neuen Calciumphosphat-Zement nach Ballon-Kyphoplastie. Orthopäde 2004; 33: 31-39

(4) Hillmeier J, Grafe I, Da Fonseca K, Meeder PJ, Nöldge G, Libicher M, Kock HJ, Haag M, Kapserk C. Die Wertigkeit der Ballonkyphoplastie bei der osteoporotischen Wirbelkörperfraktur. Orthopäde 2004; 33: 893-904

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

(6) Ooms EM, Wolke JGC, Jansen JA. Evaluation of a high strength calcium phosphate bone cement. 6th World Biomaterials Congress, Hawaii, USA, 15-20th May 2000

(7) Ooms EM, Wolke JGC, van der Waerden JPCM, Jansen JA. Trabecular bone response to injectable calcium phosphate (Ca-P) cement. J Biomed Mater Res 2002; 61: 9-18

(8) 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

(9) Ooms EM, Egglezos EA, Wolke JGC, Jansen JA. Soft-tissue response to injectable calcium phosphate cements. Biomaterials 2003; 24: 749-757

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

(11) Wolke JGC, Wenz R, Ooms EM, Boltong MG, Driessens FCM, Jansen JA. Physicochemical properties, composition and in vivo resorption behaviour of a high strength calcium phosphate cement. Concepts and clinical applications of ionic cements. 15th European Conference on Biomaterials, Arcachon, Bordeaux, France, 1999

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.