Calcium phosphate bone cement and biodegradable mesh-like microporous balloon for vertebroplasty

doi:10.3969/j.issn.2095-4344.2014.47.005

Abstract

Abstract:

BACKGROUND: In vitro experiments have demonstrated that the biodegradable mesh-like microporous balloon made of macromolecular materials has obvious advantage of anti-leakage, which is capable of maintaining calcium homeostasis, has no inhibitory effects on cell growth and on microscopic interdigitation formation between new bone and bone cement.
OBJECTIVE: To evaluate the therapeutic effects of biodegradable mesh-like microporous balloon with calcium bone cement on vertebral fractures based on animal experiments.
METHODS: The fracture model was established in 48 New Zealand rabbits, in which a bone drill was introduced after successful puncture at sites near left low extremity of the femur. These rabbit models were randomized into two groups: experimental group with calcium phosphate bone cement and biodegradable mesh-like microporous balloon and control group only with calcium phosphate bone cement. Clinical parameters such as blood cell count, biochemistry, and CT/X ray were examined at 1, 3 and 6 months after implantation of the balloon and bone cement. After that, the specimens were fixed for pathological analysis.
RESULTS AND CONCLUSION: The operation was performed under general anesthesia with no eventful infusion of bone cement. The expansion of balloon was satisfactory without definite extravasation of bone cement in the experimental group. In the control group, cement diffusion was found with pulmonary embolism occurring in three New Zealand rabbits. No statistical significance for blood cell counts and biochemistry was found between pre- and postoperation or between two groups. The materials in the two groups had favorable biocompatibility with injured bones without obvious immunological response. In the experimental group, the balloon wall was thinned and partial bone tissues grew into the cement at 1 month; at 3 months, a large amount of bone tissues grew into the cement and cement volume diminished; at 6 months, the balloon disappeared and only a small amount of cement left in the bone tissues. In the control group, it was difficult to determine when the cement degraded. The biodegradable mesh-like microporous balloon combined with calcium bone cement is superior to bone cement alone in the management of vertebral fractures.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

全文链接：

Key words: nanofibers, fractures, biocompatible materials

CLC Number:

R318

Xie Zhi-yong, Liu Xun-wei, Zhong Jian, Wei Dai-xu, Ye Yong, Du Yan-xia, Sun Gang . Calcium phosphate bone cement and biodegradable mesh-like microporous balloon for vertebroplasty[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(47): 7566-7572.

Figures/Tables 5

References

[1] Tzermiadianos MN,Renner SM,Phillips FM,et al.Altered discpressure profile after an osteoporotic vertebral fracture is a risk factor for adjacent vertebral body fracture.Eur Spine J. 2008;17:1522-1530.
[2] Sun YC,Teng MM,Yuan WS,et al. Risk of post-vertebroplasty fracture in adjacent vertebral bodies appears correlated with the morphologic extent of bone cement. J Chin Med Assoc. 2011;74(8):357-362.
[3] Frankel BM,Monroe T,Wang C.Percutaneous vertebral augmentation: an elevation in adjacent-level fracture risk in kyphoplasty as compared with vertebroplasty. Spine J. 2007; 7(5):575-582.
[4] Zou J,Mei X,Zhu X,et al.The long-term incidence of subsequent vertebral body fracture after vertebral augmentation therapy: a systemic review and meta-analysis. Pain Physician.2012;15(4):E515-522.
[5] Brodano GB,Amendola L,Martikos K,et al.Vertebroplasty: benefits are more than risks in selected and evidence-based informed patients. A retrospective study of 59 cases. Eur Spine J.2011;20(8):1265-1271.
[6] Bula P,Lein T,Strassberger C,et al.Balloon kyphoplasty in the treatment of osteoporotic vertebral fractures: indications- treatment strategy-complications. Z Orthop Unfall. 2010; 148(6):646-656.
[7] Sun G,Jin P,Li M,et al.Height restoration and wedge anglecorrection effects of percutaneous vertebroplasty: association with intraosseous clefts.Eur Radiol. 2011;21: 2597-2603.
[8] Wagner AL,Baskurt E.Refracture with cement extrusion following percutaneous vertebroplasty of a large interbody cleft.AJR Am J Roentgenol.2006;27:230-231.
[9] Voormolen MH,Lohle PN,Juttmann JR,et al.The risk of new osteoporotic vertebral compression fractures in the year after percutaneous vertebroplasty. J Vasc Interv Radiol. 2006; 17(1):71-76.
[10] Togawa D,Kovacic JJ,Bauer TW,et al.Radiographic and histologic findings of vertebral augmentation using polymethylmethacrylate in the primate spine: percutaneous vertebroplasty versus kyphoplasty.Spine.2006;31:E4-10.
[11] 周鑫,夏群,苗军,等.磷酸钙骨水泥改性研究进展[J].中国矫形外科杂志,2008,16(1):55-57.
[12] Lieberman IH,Togawa D,et al.Vertebroplasty and kyphoplasty: filler materials .Spine J.2005;11:305S-316S.
[13] van de Watering FC,van den Beucken JJ,Walboomers XF,et al.Calcium phosphate/poly(D,L-lactic-co-glycolic acid) composite bone substitute materials: evaluation of temporal degradation and bone ingrowth in a rat critical-sized cranial defect.Clin Oral Implants Res.2012;23:151-159.
[14] Aberg J,Henriksson HB,Engqvist H,et al. Biocompatibility and resorption of a radiopaque premixed calcium phosphate cement.J Biomed Mater Res A.2012;100: 1269-1278.
[15] Cherng A,Takagi S,Chow LC.Effects of hydroxypropyl methylcellulose and other gelling agents on the handling properties of calcium phosphate cement. J Biomed Mater Res.1997;35(3):273-277.
[16] Ling Chen, Hong Xiang, Xiao Xi Li, et al. Improvement of the anti-washout performance of calcium phosphate cement by use of modified starch. Key Engineering Materials. 2007; 336-338:1628-1631.
[17] Qian G,Dong Y,Yang W,et al.Injectable calcium phosphate cement and fibrin sealant recombined human bone morphogenetic protein-2 composite in vertebroplasty: an animal study.Bosn J Basic Med Sci.2012;12(4):231-235.
[18] Schumacher M,Hen A,Rohnke M,et al.A novel and easy-to-prepare strontium(II) modified calcium phosphate bone cement with enhanced mechanical properties. Acta Biomater.2013;9(7):7536-7544.
[19] Christel T,Kuhlmann M,Vorndran E,et al.Dual setting α-tricalcium phosphate cements.J Mater Sci Mater Med. 2013;24(3):573-581.
[20] Tarsuslugil SM,O'Hara RM,Dunne NJ,et al.Development of calcium phosphate cement for the augmentation of traumatically fractured porcine specimens using vertebroplasty. J Biomech.2013;46(4):711-715.
[21] Sun G,Wei D,Liu X,et al.Novel biodegradable electrospun nanofibrous P(DLLA-CL) balloons for the treatment of vertebral compression fractures.Nanomedicine. 2013;9(6): 829-838.
[22] 彭湘涛,刘训伟,李敏,等.可降解高分子网状球囊及磷酸钙骨水泥椎体填充后的力学变化[J].中国组织工程研究,2013,17(51): 8795-8800.
[23] 刘训伟,钟建,彭湘涛,等.联合钙盐骨水泥及可降解网状微孔球囊椎体成形的体外实验[J].中国组织工程研究,2014,18(12): 1817-1823.
[24] 中华人民共和国科学技术部.关于善待实验动物的指导性意见. 2006-09-30.
[25] Galovich LA,Perez-Higueras A,Altonaga JR,et al. Biomechanical, histological and histomorphometric analyses of calcium phosphate cement compared to PMMA for vertebral augmentation in a validated animal model. Eur Spine J.2011;20(Suppl 3):S376-S382.
[26] Galibert P,Deramond H,Rosat P,et al.Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty. Neurochirurgie.1987;33(2):166-168.
[27] Rao RD,Singrakhia MD.Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003; 85-A(10):2010-2022.
[28] Foo LS,Yeo W,Fook S,et al.Results, experience and technical points learnt with use of the SKy Bone Expander kyphoplasty system for osteoporotic vertebral compression fractures: a prospective study of 40 patients with a minimum of 12 months of follow-up.Eur Spine J.2007;16(11):1944-1950.
[29] 孙钢,金鹏,易玉海,等.用国产器械行椎体后凸成形术治疗老年骨质疏松脊柱压缩骨折的价值[J].中华放射学杂志,2006,40(10): 1089-1092.
[30] Zheng Z,Luk KD,Kuang G,et al. Vertebral augmentation with a novel Vessel-X bone void filling container system and bioactive bone cement.Spine (Phila Pa 1976). 2007;32(19): 2076-2082.
[31] Panagiotis K1,Konstantinos V,Vasilios V,et al.Is Kiva implant advantageous to balloon kyphoplasty in treating osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques: a prospective randomized controlled short-term study.Spine (Phila Pa 1976). 2014; 39(4):E231- E239.