Preliminary experience with new synthetic ceramic bone substitute - Cerament™ Spine Support – in Vertebral Compression Fracture(VCF): short term follow-up at 9 months about 15 cases. F.Zeccolini, A.Lavanga, G.Ambrosanio, P.Vassallo, G. Guarnieri, M. Muto Neuroradiology Unit- AO Cardarelli Naples ITALY XIX Symposium Neuroradiologicum Bologna october 4-9, 2010 Bologna october 4-9, 2010

Cerament Spine Support is a synthetic ceramic bone substitute which is Intended for augmentation of the vertebral body Cerament Spine Support is a synthetic ceramic bone substitute which is Intended for augmentation of the vertebral body Component parts Component parts CERAMENT™|CMI CERAMENT™|CMI Combined mixing and injection device Combined mixing and injection device Pre-filled with ceramic bone substitute Pre-filled with ceramic bone substitute CERAMENT™|C-TRU CERAMENT™|C-TRU Iodine based radio opacity enhancing component Iodine based radio opacity enhancing component CERAMENT™|DISTRIBUTOR CERAMENT™|DISTRIBUTOR 8x1 ml syringes 8x1 ml syringes Valve Valve

60% alpha-calcium sulfate (α-CaS) and 40% hydroxyapatite (HA) 60% alpha-calcium sulfate (α-CaS) and 40% hydroxyapatite (HA) Used individually in orthopedics for more than 40 years Used individually in orthopedics for more than 40 years Biphasic – two phases that complement each other Biphasic – two phases that complement each other CaS dissolves with time (during weeks/months) producing porosity that allows for ingrowth of host bone which surrounds the osteoconductive HA particles CaS dissolves with time (during weeks/months) producing porosity that allows for ingrowth of host bone which surrounds the osteoconductive HA particles Unique ratio between CaS and HA favors spontaneous precipitation of nanocrystalline apatite on the surface which enhances direct contact between implant and bone Unique ratio between CaS and HA favors spontaneous precipitation of nanocrystalline apatite on the surface which enhances direct contact between implant and bone Preloaded in mixing device (CMI) Preloaded in mixing device (CMI) Precisely measured for exact dosages in closed system Precisely measured for exact dosages in closed system Synthetically produced for high purity and reproducibility Synthetically produced for high purity and reproducibility Easy mixing process which ensures a smooth, homogenous consistency of the paste Easy mixing process which ensures a smooth, homogenous consistency of the paste

α-calcium sulfate(60%)hydroxyapatite(40%) +

+ powderiohexol

Bioactive Biocompatible Osteoconductive

New bone growth

Materials and methods 13 patients with symptomatic porotic fractures (between y. o.) underwent Cerament VP 13 patients with symptomatic porotic fractures (between y. o.) underwent Cerament VP 2 patients post - traumatic 35 and 55 y.o. with pain and Magerl A1 fractures or bone contusion 2 patients post - traumatic 35 and 55 y.o. with pain and Magerl A1 fractures or bone contusion MR and CT /X ray was performed before the procedure MR and CT /X ray was performed before the procedure In 1 case bone scan was perform (no MR possible) In 1 case bone scan was perform (no MR possible) Time preparation of the BS is 5 minutes before inj., to reduce the incidence of venous leakage Time preparation of the BS is 5 minutes before inj., to reduce the incidence of venous leakage VAS and ODS evaluation before, at 1, 3, 6 and 9 months VAS and ODS evaluation before, at 1, 3, 6 and 9 months Follow - up x ray was performed at 1, 3 and 9 months Follow - up x ray was performed at 1, 3 and 9 months

Exclusions criteria Metastasis Metastasis Osteoangioma Osteoangioma Kummel’s disease Kummel’s disease

Results VAS was reduced up to 3 and 6 point at 1, 3, 6 and 9 months follow up VAS was reduced up to 3 and 6 point at 1, 3, 6 and 9 months follow up ODS decreased more than 40% and 60% at 1, 3, 6 and 9 months follow-up ODS decreased more than 40% and 60% at 1, 3, 6 and 9 months follow-up 1 refracture of the distant metamer at 6 months was noted. 1 refracture of the distant metamer at 6 months was noted. No significant difference with PMMA in term of radiopacity and density. No significant difference with PMMA in term of radiopacity and density.

Discussion PMMA PMMA Osteoconductive Osteoconductive Osteoinductive Osteoinductive Biocompatible Biocompatible

1.Nilsson M. Injectable calcium sulphate and calcium phosphate bone substitutes, Thesis, Lund, 2003, ISBN Nilsson M. Injectable calcium sulphate and calcium phosphate bone substitutes, Thesis, Lund, 2003, ISBN Nilsson M, Wang J-S, Wielanek L, Tanner KE andLidgren L. Biodegradation and biocompatibility of a calcium sulphate- hydroxyapatite bone substitute,J Bone Joint Surg [Br] 2004; 86- B: Nilsson M, Wang J-S, Wielanek L, Tanner KE andLidgren L. Biodegradation and biocompatibility of a calcium sulphate- hydroxyapatite bone substitute,J Bone Joint Surg [Br] 2004; 86- B: Nilsson M, Wielanek L, Wang J-S, Tanner KE andLidgren L. Factors influencing the compressivestrength of an injectable calcium sulphatehydroxyapatite cement, J Mater Sci: Mater in Med 2003; 14: Nilsson M, Wielanek L, Wang J-S, Tanner KE andLidgren L. Factors influencing the compressivestrength of an injectable calcium sulphatehydroxyapatite cement, J Mater Sci: Mater in Med 2003; 14: Wang JS, Zhang M, McCarthy I, Tanner KE and Lidgren L. Biomechanics and bone integration on injectable calcium sulphate and hydroxyapatite in large bone defect in rat, poster presentation at ORS,Chicago Wang JS, Zhang M, McCarthy I, Tanner KE and Lidgren L. Biomechanics and bone integration on injectable calcium sulphate and hydroxyapatite in large bone defect in rat, poster presentation at ORS,Chicago Wang J-S, Nilsson M, McCarthy I, Tanner KE andvLidgren L. Resorption and bone ingrowth of injectable bone substitute: a comparative study in rabbit, oral presentation at EORS, Helsinki Wang J-S, Nilsson M, McCarthy I, Tanner KE andvLidgren L. Resorption and bone ingrowth of injectable bone substitute: a comparative study in rabbit, oral presentation at EORS, Helsinki Wang J-S, Nilsson M, Wielanek L, Tanner KE and Lidgren L. Biodegradation and biocompatibility of a calcium sulphate with hydroxyapatite bone substitute,poster presentation at ORS, Tampa Wang J-S, Nilsson M, Wielanek L, Tanner KE and Lidgren L. Biodegradation and biocompatibility of a calcium sulphate with hydroxyapatite bone substitute,poster presentation at ORS, Tampa 2002

7. Wielanek L, Nilsson M, Wang J-S Tanner KE and Lidgren L. Effect of α- irradiation sterilisation on 7. Wielanek L, Nilsson M, Wang J-S Tanner KE and Lidgren L. Effect of α- irradiation sterilisation on compressive strength of calcium sulfate with hydroxyapatite bone substitute, poster presentation compressive strength of calcium sulfate with hydroxyapatite bone substitute, poster presentation at EORS, Wiesbaden at EORS, Wiesbaden Nilsson M, Wielanek L, Wang J-S, Tanner KE and Lidgren L. Influence of different hydroxyapatite on the compressive strength in a calcium sulphate based bone substitute, oral presentation at EORS, 8. Nilsson M, Wielanek L, Wang J-S, Tanner KE and Lidgren L. Influence of different hydroxyapatite on the compressive strength in a calcium sulphate based bone substitute, oral presentation at EORS, Weisbaden Weisbaden Nilsson M, Wang J-S, Wielanek L, Tanner KE and Lidgren L. Compressive strength of calcium sulphate with hydroxyapatite cement, poster presentation at 6th World Biomaterials, Hawaii Nilsson M, Wang J-S, Wielanek L, Tanner KE and Lidgren L. Compressive strength of calcium sulphate with hydroxyapatite cement, poster presentation at 6th World Biomaterials, Hawaii Wang J-S, Nilsson M, Wielanek L, Tanner KE and Lidgren L. Factors controlling the injection and setting of calcium sulphate with hydroxyapatite cement, 10. Wang J-S, Nilsson M, Wielanek L, Tanner KE and Lidgren L. Factors controlling the injection and setting of calcium sulphate with hydroxyapatite cement, poster presentation at 6th World Biomaterials, Hawaii poster presentation at 6th World Biomaterials, Hawaii Rauschmann M, Hierholzer J, Werba T, VoglT, Verheyden A, and Pflugmacher R. Ceramic Vertebral Augmentation. A multicenter trial with 11. Rauschmann M, Hierholzer J, Werba T, VoglT, Verheyden A, and Pflugmacher R. Ceramic Vertebral Augmentation. A multicenter trial with CERAMENT™|SPINE SUPPORT, in osteoporotic patients suffering from vertebral compression fractures. CERAMENT™|SPINE SUPPORT, in osteoporotic patients suffering from vertebral compression fractures. Presented at EUROSPINE 2007, Brussels, Oct 4, Presented at EUROSPINE 2007, Brussels, Oct 4, 2007.

Conclusions Cerament bone substitute has shown to have in VPF good pain relief property, no major or minor complications, no refractures. Cerament bone substitute has shown to have in VPF good pain relief property, no major or minor complications, no refractures. The rationality of the material suggested to use it mostly in porotic patients, with exclusion of Kummel’s disease. The rationality of the material suggested to use it mostly in porotic patients, with exclusion of Kummel’s disease. More patients and clinical trial are necessary to check long term follow-up More patients and clinical trial are necessary to check long term follow-up

The End