Combined use of poly(methyl methacrylate) bone cement and injectable artificial bone implantation for senile degenerative thoracic osteoporotic vertebral compression fractures: study protocol for a randomized controlled trial

doi:10.3969/j.issn.2095-4344.0708

Abstract

Abstract:

BACKGROUND: Percutaneous kyphoplasty is an effective treatment method for senile degenerative thoracic osteoporotic vertebral compression fractures. However, its clinical long-term effect is controversial among scholars both inside and outside China. The poly(methyl methacrylate) (PMMA) bone cement commonly used in percutaneous kyphoplasty has good plasticity and formability, but its biocompatibility is not yet clear. Injectable artificial bone is a novel filling material to induce bone formation, but its long-term efficacy remains to be verified.

OBJECTIVE: To compare the efficacy of OSTEOPAL®Plus PMMA bone cement and GeneX® injectable artificial bone graft in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures at 24 months postoperatively.

METHODS: This is a prospective, single-center, open-label, randomized controlled clinical trial. A total of 378 patients with senile degenerative thoracic osteoporotic vertebral compression fractures will be recruited from the Department of Orthopedics, Affiliated Hospital of Qinghai University, China. The patients will be randomized into two groups and undergo percutaneous kyphoplasty. The PMMA group (n=189) will be treated with OSTEOPAL®Plus PMMA bone cement. The artificial bone group (n=189) will be treated with GeneX® injectable artificial bone. Follow-ups will be conducted at 1 week and at 3, 6, 12, and 24 months. The primary outcome measure will be the vertebral body height restoration rate at 24 months postoperatively to evaluate the repair effect of the damaged thoracic vertebra. The secondary outcome measures will be the vertebral body height restoration rate at 1 week and 3, 6, and 12 months postoperatively; the incidence of bone cement leakage at 1 week and 3, 6, 12, and 24 months postoperatively; the visual analog scale score, Oswestry Disability Index, compression rate of the anterior vertebral height, and thoracic morphology revealed by computed tomography preoperatively and at 1 week and 3, 6, 12, and 24 months postoperatively; and the incidence of adverse reactions at 1 week and 3, 6, 12, and 24 months postoperatively.

DISCUSSION: Our results will verify whether OSTEOPAL®Plus PMMA bone cement and GeneX® injectable artificial bone graft are effective and safe for treating senile degenerative thoracic osteoporotic vertebral compression fractures in the short-term and at the 2-year follow-up. This study was approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China in November 2017 (approval number: 2017-11). The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants who will be fully informed of study protocol and process. This trial was designed in December 2017. The recruitment of subjects and data collection will begin in July 2018. Outcome measures will be analyzed in September 2020. This trial will be completed in October 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration No: ChiCTR1800015411). The version of this study protocol is 1.0.

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

Key words: Tissue Engineering, Osteoporosis, Biocompatible Materials

CLC Number:

R318

Zhang Yuan, Ren Rong, Li Ze-qing, Hu Yi-bo, Li Ming. Combined use of poly(methyl methacrylate) bone cement and injectable artificial bone implantation for senile degenerative thoracic osteoporotic vertebral compression fractures: study protocol for a randomized controlled trial[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(10): 1511-1516.

Figures/Tables 1

References

[1]Li X, Lu Y, Lin X. Refracture of osteoporotic vertebral body after treatment by balloon kyphoplasty: three cases report. Medicine (Baltimore). 2017;96:e8961.

[2]Pfeifer M, Gehlen M, Hinz C. Spinal orthoses in the treatment of vertebral fractures with osteoporosis: a systematic review article. Z Rheumatol. 2017;76:860-868.

[3]Schnake KJ, Bula P, Spiegl UJ, et al. Thoracolumbar spinal fractures in the elderly:classification and treatment. Unfallchirurg. 2017;120:1071-1085.

[4]Hajnovic L, Sefranek V, Schütz L. Influence of blood supply on fracture healing of vertebral bodies. Eur J Orthop Surg Traumatol. 2017. doi: 10.1007/s00590-017-2069-7.

[5]Ye LQ, Liang, Jiang XB, et al. Risk factors for the occurrence of insufficient cement distribution in the fractured area after percutaneous vertebroplasty in osteoporotic vertebral compression fractures. Pain Physician. 2018;21:E33-E42.

[6]Youn MS, Shin JK, Goh TS, et al. Minimally invasive percutaneous endoscopic treatment for acute pyogenic spondylodiscitis following vertebroplasty. Eur Spine J. 2018. doi: 10.1007/s00586-018-5478-3.

[7]Lim J, Choi SW, Youm JY, et al. Posttraumatic delayed vertebral collapse: kummell's disease. J Korean Neurosurg Soc. 2018. doi: 10.3340/jkns.2017.0505.010.

[8]Beall DP, Tutton SM, Murphy K, et al. Analysis of Reporting Bias in Vertebral Augmentation. Pain Physician. 2017;20: E1081-E1090.

[9]Leali PT, Solla F, Maestretti G, et al. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. 2016;13:234-236.

[10]葛付涛,赵松,牛丰,等.磷酸钙骨水泥球囊撑开椎体成形术治疗骨质疏松性椎体骨折[J].中国骨伤,2014,27(2):128-132.

[11]Wang H, Zhang Z, Liu Y, et al. Percutaneous kyphoplasty for the treatment of very severe osteoporotic vertebral compression fractures with spinal canal compromise. J Orthop Surg Res. 2018;13:13.

[12]Jin C, Xu G, Weng D, et al. Impact of magnetic resonance imaging on treatment-related decision making for osteoporotic vertebral compression fracture: a prospective randomized trial. Med Sci Monit. 2018;24:50-57.

[13]Y?lmaz A, Çak?r M, Yüceta? C?, et al. Percutaneous kyphoplasty, is bilateral approach necessary? Spine (Phila Pa 1976). 2017. doi: 10.1097/BRS.0000000000002531.

[14]Jia-Jia S, Zhi-Yong S, Zhong-Lai Q, et al. Tuberculous spondylitis after vertebral augmentation: a case report with a literature review. J Int Med Res. 2017. doi:10.1177/0300060517728008.

[15]Shang LP, Tian Y, Liu XG. Clinical comparison of polymethylmethacrylate and bone cement in the treatment of osteoporotic vertebral compression fractures: a retrospective study. Beijing Da Xue Xue Bao Yi Xue Ban. 2017;49:267-273.

[16]Xu BS, Hu YC, Yang Q, et al. Long-term results and radiographic findings of percutanous vertebroplasties with polymethylmethacrylate for vertebral osteoporotic fractures. Chin Med J (Engl). 2012;125:2832-2836.

[17]Knop C, Oeser M, Bastian L, et al. Development and validation of the Visual Analogue Scale (VAS) Spine Score. Unfallchirurg. 2011;104:488-497.

[18]Ruiz FK, Bohl DD, Webb ML, et al. Oswestry Disability Index is a better indicator of lumbar motion than the Visual Analogue Scale. Spine J. 2014;14:1860-1865.

[19]杨惠林,牛国旗,梁道臣,等.单球囊与双球囊后凸成形术对椎体复位作用的研究[J].中华外科杂志,2004,42(21):1299-1302.

[20]邢文钊,张志国,刘长城,等.小剂量骨水泥注射治疗老年骨质疏松性椎体压缩骨折[J].中华创伤骨科杂志,2010,12(10):976-978.

[21]Zhang C, Wang G, Liu X, et al. Failed percutaneous kyphoplasty in treatment of stage 3 Kummell disease: A case report and literature review. Medicine (Baltimore). 2017; 96(47):e8895.

[22]Liu H, Liu B, Gao C, et al. Injectable, biomechanically robust, biodegradable and osseointegrative bone cement for percutaneous kyphoplasty and vertebroplasty. Int Orthop. 2018;42(1):125-132.

[23]Karmakar A, Acharya S, Biswas D, et al. Evaluation of Percutaneous Vertebroplasty for Management of Symptomatic Osteoporotic Compression Fracture. J Clin Diagn Res. 2017;11(8):RC07-RC10.

[24]Bai M, Yin H, Zhao J, et al. Application of PMMA bone cement composited with bone-mineralized collagen in percutaneous kyphoplasty. Regen Biomater. 2017;4(4):251-255.

[25]Shang LP, Tian Y, Liu XG. Clinical comparison of polymethylmethacrylate and bone cement in the treatment of osteoporotic vertebral compression fractures: a retrospective study. Beijing Da Xue Xue Bao Yi Xue Ban. 2017;49(2): 267-273.

[26]Maugeri R, Graziano F, Basile L, et al. Reconstruction of Vertebral Body After Radiofrequency Ablation and Augmentation in Dorsolumbar Metastatic Vertebral Fracture: Analysis of Clinical and Radiological Outcome in a Clinical Series of 18 Patients. Acta Neurochir Suppl. 2017;124:81-86.

[27]Dmytriw AA, Talla K, Smith R. Percutaneous sacroplasty for the management of painful pathologic fracture in a multiple myeloma patient: case report and review of the literature. Neuroradiol J. 2017;30(1):80-83.

[28]Xin L, Bungartz M, Maenz S, et al. Decreased extrusion of calcium phosphate cement versus high viscosity PMMA cement into spongious bone marrow-an ex vivo and in vivo study in sheep vertebrae. Spine J. 2016;16(12):1468-1477.

[29]Molloy T, Kos A, Piwowarski A. Robotic-Assisted Removal of Intracardiac Cement After Percutaneous Vertebroplasty. Ann Thorac Surg. 2016;101(5):1974-1976.

[30]Germaneau A, Vendeuvre T, Saget M, et al. A novel approach for biomechanical spine analysis: Mechanical response of vertebral bone augmentation by kyphoplasty to stabilise thoracolumbar burst fractures. J Mech Behav Biomed Mater. 2016;59:291-303.

[31]杨鹤.GENEX强化术用于预防多个椎体成形术后临近椎体再骨折的疗效观察[D].北京:首都医科大学,2015.