PRELIMINARY EFFECTIVENESS OF POLYAMINOACID/NANO-HYDROXYAPATITE/CALCIUM SULFATE CAGE IN LUMBAR FUSION SURGERY_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

MALongbing , JIAYunbing , SONGYueming ,  LITao , LIULimin , GONGQuan , LIUHao , ZENGJiancheng , ZHOUZhongjie , MALitai

Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China;

Corresponding author：

LITao, Email: litao55@hotmail.com

Keywords：

Lumbar fusion surgery; Cage; Polyaminoacid/nano-hydroxyapatite/calcium sulfate; Polyetheretherketone

DOI：

10.7507/1002-1892.20160065

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To discuss the early effectiveness of polyaminoacid/nano-hydroxyapatite/calcium sulfate (PAA/HA/CS) Cage (PHC Cage) in lumbar fusion surgery. Methods Thirty cases undergoing lumbar fusion of single segment between March and September 2014 were enrolled in this study. The patients were randomly divided into the trial group (n=20) and the control group (n=10). The PHC Cage was implanted in the trial group, while the polyetheretherketone (PEEK) Cage was implanted in the control group. The patients of 2 groups mainly presented lumbocrural pain and lower limb radiation pain or numbness. There was no significant difference in gender, age, type, affected segment, disease duration, preoperative intervertebral height, the lordosis angle of fusion segments, and the Oswestry Disability Index (ODI) between 2 groups (P > 0.05). Lateral lumbar X-ray films and three dimensional CT were taken preoperatively and at 1 week and 3, 6, and 12 months postoperatively. The intervertebral height and the lordosis angle of fusion segments at 1 week and 3, 6, and 12 months after operation and ODI at 3, 6, and 12 months after operation were measured; and the bone graft fusion rate was evaluated according to Brantigan criteria. Results There was no significant difference in operation time, intraoperative blood loss, and the amount of autologous blood transfusion between 2 groups (P > 0.05). Healing by first intention was obtained in 30 cases. All patients were followed up 12 months. The intervertebral height of fusion segments, the lordosis angle of fusion segments, and ODI at each time point after operation were significantly improved when compared with preoperative ones (P < 0.05). The ODI showed significant difference between 3 months and 6, 12 months (P < 0.05), but there was no significant difference between the other time points after operation (P > 0.05). There was no significant difference in the intervertebral height and the lordosis angle of fusion segments between groups at different time points (P > 0.05). There was no significant difference in the above indexes between the trial group and the control group at each time point (P > 0.05). At last follow-up, 5 cases were rated as Brantigan grade E, 13 cases as grade D, and 2 cases as grade C in the trial group; 4 cases were rated grade E, 5 cases as grade D, and 1 case as grade C in the control group. The bone fusion rate was 90% in 2 groups. Conclusion The PHC Cage can effectively restore and maintain the disc height of fusion segment, normal sequence and biomechanical stability of the lumbar spine. The PHC Cage is similar to the PEEK Cage and has good clinical outcome in short-term follow-up.

Citation： MALongbing, JIAYunbing, SONGYueming, LITao, LIULimin, GONGQuan, LIUHao, ZENGJiancheng, ZHOUZhongjie, MALitai. PRELIMINARY EFFECTIVENESS OF POLYAMINOACID/NANO-HYDROXYAPATITE/CALCIUM SULFATE CAGE IN LUMBAR FUSION SURGERY. Chinese Journal of Reparative and Reconstructive Surgery, 2016, 30(3): 328-335. doi: 10.7507/1002-1892.20160065 Copy

1.	Trouillier H, Birkenmaier C, Rauch A, et al. Posterior lumbar interbody fusion (PLIF) with cages and local bone graft in the treatment of spinal stenosis. Acta Orthop Belg, 2006, 72(4): 460-466.
2.	DiPaola CP, Molinari RW. Posterior lumbar interbody fusion. J Am Acad Orthop Surg, 2008, 16(3): 130-139.
3.	Rousseau MA, Lazennec JY, Saillant G. Circumferential arthrodesis using PEEK cages at the lumbar spine. J Spinal Disord Tech, 2007, 20(4): 278-281.
4.	Kao TH, Wu CH, Chou YC, et al. Risk factors for subsidence in anterior cervical fusion with stand-alone polyetheretherketone (PEEK) cages: a review of 82 cases and 182 levels. Arch Orthop Trauma Surg, 2014, 134(10): 1343-1351.
5.	Yang JJ, Yu CH, Chang BS, et al. Subsidence and nonunion after anterior cervical interbody fusion using a stand-alone polyetheretherketone (PEEK) Cage. Clin Orthop Surg, 2011, 3(1): 16-23.
6.	邓茜, 姜勇, 王丽敏.中国成年人体重指数与生命质量的关系研究.中华流行病学杂志, 2014, 35(5): 557-561.
7.	Brantigan JW, Steffee AD. A carbon fiber implant to aid interbody lumbar fusion. Two-year clinical results in the first 26 patients. Spine (Phila Pa 1976), 1993, 18(14): 2106-2117.
8.	刘列华, 兰阳军, 周强.腰椎融合手术方式的历史与进展.中国矫形外科杂志, 2013, 21(24): 2486-2489.
9.	Bagby GW. Arthrodesis by the distraction-compression method using a stainless steel implant. Orthopedics, 1988, 11(6): 931-934.
10.	Goh JC, Wong HK, Thambyah A, et al. Influence of PLIF cage size on lumbar spine stability. Spine (Phila Pa 1976), 2000, 25(1): 35-39.
11.	张映波, 付能高, 张伟, 等.后路椎间打压植骨融合与聚醚醚酮植骨融合治疗腰椎不稳的临床研究.川北医学院学报, 2013, 28(3): 257-261.
12.	Suh KT, Park WW, Kim SJ, et al. Posterior lumbar interbody fusion for adult isthmic spondylolisthesis: a comparison of fusion with one or two cages. J Bone Joint Surg (Br), 2008, 90(10): 1352-1356.
13.	Castellvi AE, Castellvi A, Clabeaux DH. Corpectomy with titanium cage reconstruction in the cervical spine. J Clin Neurosci, 2012, 19(4): 517-521.
14.	马华松.植入物置入内固定治疗腰椎退变性疾病.中国组织工程研究, 2012, 16(44): 8332-8339.
15.	Kanayama M, Cunningham BW, Haggerty CJ, et al. In vitro biomechanical investigation of the stability and stress-shielding effect of lumbar interbody fusion devices. J Neurosurg, 2000, 93(2 Suppl): 259-265.
16.	Van Dijk M, Smit TH, Sugihara S, et al. The effect of Cage stiffness on the rate of lumbar interbody fusion: an in vivo model using poly (l-lactic acid) and titanium Cages. Spine (Phila Pa 1976), 2002, 27(7): 682-688.
17.	严永刚, 任浩浩, 刘朋真, 等.多元氨基酸聚合物-羟基磷灰石骨修复材料、支撑型植入物及制备方法.中国: CN104324415A. 2015-02-04.
18.	Li H, Yan Y, Wei J, et al. Bone substitute biomedical material of multi-(amino acid) copolymer: in vitro degradation and biocompatibility. J Mater Sci Mater Med, 2011, 22(11): 2555-2563.
19.	Becker ST, Douglas T, Acil Y, et al. Biocompatibility of individually designed scaffolds with human periosteum for use in tissue engineering. J Mater Sci Mater Med, 2010, 21(4): 1255-1262.
20.	Douglas T, Liu Q, Humpe A, et al. Novel ceramic bone replacement material CeraBall seeded with human mesenchymal stem cells. Clin Oral Implants Res, 2010, 21(3): 262-267.
21.	Ripamonti U, Crooks J, Khoali L, et al. The induction of bone formation by coral-derived calcium carbonate/hydroxyapatite constructs. Biomaterials, 2009, 30(7): 1428-1439.
22.	杨晓波, 裴福兴, 严永刚, 等.聚氨基酸复合纳米羟基磷灰石的体内生物相容性实验研究.中国矫形外科杂志, 2010, 18(21): 1809-1813.
23.	代震宇, 李军, 赵增辉, 等.纳米羟基磷灰石/聚氨基酸复合材料生物安全性评价.第三军医大学学报, 2010, 32(21): 2294-2299.
24.	李军, 代震宇, 赵增辉, 等.纳米羟基磷灰石/聚氨基酸复合材料的生物相容性研究.重庆医科大学学报, 2010, 35(12): 1840-1843.
25.	Wang H, Li Y, Zuo Y, et al. Biocompatibility and osteogenesis of biomimetic nano-hydroxyapatite/polyamide composite scaffolds for bone tissue engineering. Biomaterials, 2007, 28(22): 3338-3348.
26.	赵增辉, 蒋电明, 苏保, 等.复合骨修复材料——聚氨基酸/硫酸钙的生物相容性研究.功能材料, 2011, 42(5): 807-811.
27.	邹昌, 张帅, 段宏, 等.注射型可吸收聚氨基酸/硫酸钙复合材料动物体内的安全及组织相容性.中国组织工程研究, 2012, 16(8): 1391-1395.
28.	姜勇, 张帅, 周勇, 等.注射型可吸收聚氨基酸/硫酸钙复合材料动物体内降解吸收及促成骨作用.中国组织工程研究, 2012, 16(12): 2091-2094.
29.	严永刚, 王鹏, 李鸿, 等.可控降解多元氨基酸共聚物-有机钙/磷盐填充型复合骨植入物及制备方法.中国: CN104307048A. 2015-01-28.
30.	薛有地. PAA/n-HA/CS Cage在山羊腰椎椎间融合中应用的实验研究.成都:四川大学, 2014.
31.	Duan H, Yang H, Xiong Y, et al. Effects of mechanical loading on the degradability and mechanical properties of the nano calcium-deficient hydroxyapatite-multi (amino acid) copolymer composite membrane tube for guided bone regeneration. Int J Nanomedicine, 2013, 8: 2801-2807.
32.	Xiong Y, Li H, Zhou C, et al. Evaluation of biomechanical strength, stability, bioactivity, and in vivo biocompatibility of a novel calcium deficient hydroxyapatite/poly (amino acid) composite cervical vertebra cage. J Biomater Sci Polym Ed, 2014, 25(16): 1842-1855.
33.	Li H, Yang L, Dong X, et al. Composite scaffolds of nano calcium deficient hydroxyapatite/multi-(amino acid) copolymer for bone tissue regeneration. J Mater Sci Mater Med, 2014, 25(5): 1257-1265.
34.	Cinotti G, De Santis P, Nofroni I, et al. Stenosis of lumbar intervertebral foramen: anatomic study on predisposing factors. Spine (Phila Pa 1976), 2002, 27(3): 223-229.
35.	桑裴铭, 张明, 陈斌辉, 等.纳米羟基磷灰石/聚酰胺66复合材料融合器行经椎间孔腰椎椎体间融合术的影像学研究.中国骨伤, 2014, 27(8): 654-657.
36.	龙厚清, 植山和正, 刘少喻, 等. Prospace融合器结合关节突融合在单节段经后路腰椎间融合术中的初步应用.中国修复重建外科杂志, 2007, 21(11): 1155-1159.
37.	Kawakami M, Tamaki T, Ando M, et al. Lumbar sagittal balance influences the clinical outcome after decompression and posterolateral spinal fusion for degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976), 2002, 27(1): 59-64.
38.	Miyazaki M, Hymanson HJ, Morishita Y, et al. Kinematic analysis of the relationship between sagittal alignment and disc degeneration in the cervical spine. Spine (Phila Pa 1976), 2008, 33(23): E870-E876.

1. Trouillier H, Birkenmaier C, Rauch A, et al. Posterior lumbar interbody fusion (PLIF) with cages and local bone graft in the treatment of spinal stenosis. Acta Orthop Belg, 2006, 72(4): 460-466.
2. DiPaola CP, Molinari RW. Posterior lumbar interbody fusion. J Am Acad Orthop Surg, 2008, 16(3): 130-139.
3. Rousseau MA, Lazennec JY, Saillant G. Circumferential arthrodesis using PEEK cages at the lumbar spine. J Spinal Disord Tech, 2007, 20(4): 278-281.
4. Kao TH, Wu CH, Chou YC, et al. Risk factors for subsidence in anterior cervical fusion with stand-alone polyetheretherketone (PEEK) cages: a review of 82 cases and 182 levels. Arch Orthop Trauma Surg, 2014, 134(10): 1343-1351.
5. Yang JJ, Yu CH, Chang BS, et al. Subsidence and nonunion after anterior cervical interbody fusion using a stand-alone polyetheretherketone (PEEK) Cage. Clin Orthop Surg, 2011, 3(1): 16-23.
6. 邓茜, 姜勇, 王丽敏.中国成年人体重指数与生命质量的关系研究.中华流行病学杂志, 2014, 35(5): 557-561.
7. Brantigan JW, Steffee AD. A carbon fiber implant to aid interbody lumbar fusion. Two-year clinical results in the first 26 patients. Spine (Phila Pa 1976), 1993, 18(14): 2106-2117.
8. 刘列华, 兰阳军, 周强.腰椎融合手术方式的历史与进展.中国矫形外科杂志, 2013, 21(24): 2486-2489.
9. Bagby GW. Arthrodesis by the distraction-compression method using a stainless steel implant. Orthopedics, 1988, 11(6): 931-934.
10. Goh JC, Wong HK, Thambyah A, et al. Influence of PLIF cage size on lumbar spine stability. Spine (Phila Pa 1976), 2000, 25(1): 35-39.
11. 张映波, 付能高, 张伟, 等.后路椎间打压植骨融合与聚醚醚酮植骨融合治疗腰椎不稳的临床研究.川北医学院学报, 2013, 28(3): 257-261.
12. Suh KT, Park WW, Kim SJ, et al. Posterior lumbar interbody fusion for adult isthmic spondylolisthesis: a comparison of fusion with one or two cages. J Bone Joint Surg (Br), 2008, 90(10): 1352-1356.
13. Castellvi AE, Castellvi A, Clabeaux DH. Corpectomy with titanium cage reconstruction in the cervical spine. J Clin Neurosci, 2012, 19(4): 517-521.
14. 马华松.植入物置入内固定治疗腰椎退变性疾病.中国组织工程研究, 2012, 16(44): 8332-8339.
15. Kanayama M, Cunningham BW, Haggerty CJ, et al. In vitro biomechanical investigation of the stability and stress-shielding effect of lumbar interbody fusion devices. J Neurosurg, 2000, 93(2 Suppl): 259-265.
16. Van Dijk M, Smit TH, Sugihara S, et al. The effect of Cage stiffness on the rate of lumbar interbody fusion: an in vivo model using poly (l-lactic acid) and titanium Cages. Spine (Phila Pa 1976), 2002, 27(7): 682-688.
17. 严永刚, 任浩浩, 刘朋真, 等.多元氨基酸聚合物-羟基磷灰石骨修复材料、支撑型植入物及制备方法.中国: CN104324415A. 2015-02-04.
18. Li H, Yan Y, Wei J, et al. Bone substitute biomedical material of multi-(amino acid) copolymer: in vitro degradation and biocompatibility. J Mater Sci Mater Med, 2011, 22(11): 2555-2563.
19. Becker ST, Douglas T, Acil Y, et al. Biocompatibility of individually designed scaffolds with human periosteum for use in tissue engineering. J Mater Sci Mater Med, 2010, 21(4): 1255-1262.
20. Douglas T, Liu Q, Humpe A, et al. Novel ceramic bone replacement material CeraBall seeded with human mesenchymal stem cells. Clin Oral Implants Res, 2010, 21(3): 262-267.
21. Ripamonti U, Crooks J, Khoali L, et al. The induction of bone formation by coral-derived calcium carbonate/hydroxyapatite constructs. Biomaterials, 2009, 30(7): 1428-1439.
22. 杨晓波, 裴福兴, 严永刚, 等.聚氨基酸复合纳米羟基磷灰石的体内生物相容性实验研究.中国矫形外科杂志, 2010, 18(21): 1809-1813.
23. 代震宇, 李军, 赵增辉, 等.纳米羟基磷灰石/聚氨基酸复合材料生物安全性评价.第三军医大学学报, 2010, 32(21): 2294-2299.
24. 李军, 代震宇, 赵增辉, 等.纳米羟基磷灰石/聚氨基酸复合材料的生物相容性研究.重庆医科大学学报, 2010, 35(12): 1840-1843.
25. Wang H, Li Y, Zuo Y, et al. Biocompatibility and osteogenesis of biomimetic nano-hydroxyapatite/polyamide composite scaffolds for bone tissue engineering. Biomaterials, 2007, 28(22): 3338-3348.
26. 赵增辉, 蒋电明, 苏保, 等.复合骨修复材料——聚氨基酸/硫酸钙的生物相容性研究.功能材料, 2011, 42(5): 807-811.
27. 邹昌, 张帅, 段宏, 等.注射型可吸收聚氨基酸/硫酸钙复合材料动物体内的安全及组织相容性.中国组织工程研究, 2012, 16(8): 1391-1395.
28. 姜勇, 张帅, 周勇, 等.注射型可吸收聚氨基酸/硫酸钙复合材料动物体内降解吸收及促成骨作用.中国组织工程研究, 2012, 16(12): 2091-2094.
29. 严永刚, 王鹏, 李鸿, 等.可控降解多元氨基酸共聚物-有机钙/磷盐填充型复合骨植入物及制备方法.中国: CN104307048A. 2015-01-28.
30. 薛有地. PAA/n-HA/CS Cage在山羊腰椎椎间融合中应用的实验研究.成都:四川大学, 2014.
31. Duan H, Yang H, Xiong Y, et al. Effects of mechanical loading on the degradability and mechanical properties of the nano calcium-deficient hydroxyapatite-multi (amino acid) copolymer composite membrane tube for guided bone regeneration. Int J Nanomedicine, 2013, 8: 2801-2807.
32. Xiong Y, Li H, Zhou C, et al. Evaluation of biomechanical strength, stability, bioactivity, and in vivo biocompatibility of a novel calcium deficient hydroxyapatite/poly (amino acid) composite cervical vertebra cage. J Biomater Sci Polym Ed, 2014, 25(16): 1842-1855.
33. Li H, Yang L, Dong X, et al. Composite scaffolds of nano calcium deficient hydroxyapatite/multi-(amino acid) copolymer for bone tissue regeneration. J Mater Sci Mater Med, 2014, 25(5): 1257-1265.
34. Cinotti G, De Santis P, Nofroni I, et al. Stenosis of lumbar intervertebral foramen: anatomic study on predisposing factors. Spine (Phila Pa 1976), 2002, 27(3): 223-229.
35. 桑裴铭, 张明, 陈斌辉, 等.纳米羟基磷灰石/聚酰胺66复合材料融合器行经椎间孔腰椎椎体间融合术的影像学研究.中国骨伤, 2014, 27(8): 654-657.
36. 龙厚清, 植山和正, 刘少喻, 等. Prospace融合器结合关节突融合在单节段经后路腰椎间融合术中的初步应用.中国修复重建外科杂志, 2007, 21(11): 1155-1159.
37. Kawakami M, Tamaki T, Ando M, et al. Lumbar sagittal balance influences the clinical outcome after decompression and posterolateral spinal fusion for degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976), 2002, 27(1): 59-64.
38. Miyazaki M, Hymanson HJ, Morishita Y, et al. Kinematic analysis of the relationship between sagittal alignment and disc degeneration in the cervical spine. Spine (Phila Pa 1976), 2008, 33(23): E870-E876.

Chinese Journal of Reparative and Reconstructive Surgery

PRELIMINARY EFFECTIVENESS OF POLYAMINOACID/NANO-HYDROXYAPATITE/CALCIUM SULFATE CAGE IN LUMBAR FUSION SURGERY

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content