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：

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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.	鄧茜, 姜勇, 王麗敏.中國成年人體重指數與生命質量的關系研究.中華流行病學雜志, 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.	劉列華, 蘭陽軍, 周強.腰椎融合手術方式的歷史與進展.中國矯形外科雜志, 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.	張映波, 付能高, 張偉, 等.后路椎間打壓植骨融合與聚醚醚酮植骨融合治療腰椎不穩的臨床研究.川北醫學院學報, 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.	馬華松.植入物置入內固定治療腰椎退變性疾病.中國組織工程研究, 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.	嚴永剛, 任浩浩, 劉朋真, 等.多元氨基酸聚合物-羥基磷灰石骨修復材料、支撐型植入物及制備方法.中國: 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.	楊曉波, 裴福興, 嚴永剛, 等.聚氨基酸復合納米羥基磷灰石的體內生物相容性實驗研究.中國矯形外科雜志, 2010, 18(21): 1809-1813.
23.	代震宇, 李軍, 趙增輝, 等.納米羥基磷灰石/聚氨基酸復合材料生物安全性評價.第三軍醫大學學報, 2010, 32(21): 2294-2299.
24.	李軍, 代震宇, 趙增輝, 等.納米羥基磷灰石/聚氨基酸復合材料的生物相容性研究.重慶醫科大學學報, 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.	趙增輝, 蔣電明, 蘇保, 等.復合骨修復材料——聚氨基酸/硫酸鈣的生物相容性研究.功能材料, 2011, 42(5): 807-811.
27.	鄒昌, 張帥, 段宏, 等.注射型可吸收聚氨基酸/硫酸鈣復合材料動物體內的安全及組織相容性.中國組織工程研究, 2012, 16(8): 1391-1395.
28.	姜勇, 張帥, 周勇, 等.注射型可吸收聚氨基酸/硫酸鈣復合材料動物體內降解吸收及促成骨作用.中國組織工程研究, 2012, 16(12): 2091-2094.
29.	嚴永剛, 王鵬, 李鴻, 等.可控降解多元氨基酸共聚物-有機鈣/磷鹽填充型復合骨植入物及制備方法.中國: CN104307048A. 2015-01-28.
30.	薛有地. PAA/n-HA/CS Cage在山羊腰椎椎間融合中應用的實驗研究.成都:四川大學, 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.	桑裴銘, 張明, 陳斌輝, 等.納米羥基磷灰石/聚酰胺66復合材料融合器行經椎間孔腰椎椎體間融合術的影像學研究.中國骨傷, 2014, 27(8): 654-657.
36.	龍厚清, 植山和正, 劉少喻, 等. Prospace融合器結合關節突融合在單節段經后路腰椎間融合術中的初步應用.中國修復重建外科雜志, 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. 鄧茜, 姜勇, 王麗敏.中國成年人體重指數與生命質量的關系研究.中華流行病學雜志, 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. 劉列華, 蘭陽軍, 周強.腰椎融合手術方式的歷史與進展.中國矯形外科雜志, 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. 張映波, 付能高, 張偉, 等.后路椎間打壓植骨融合與聚醚醚酮植骨融合治療腰椎不穩的臨床研究.川北醫學院學報, 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. 馬華松.植入物置入內固定治療腰椎退變性疾病.中國組織工程研究, 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. 嚴永剛, 任浩浩, 劉朋真, 等.多元氨基酸聚合物-羥基磷灰石骨修復材料、支撐型植入物及制備方法.中國: 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. 楊曉波, 裴福興, 嚴永剛, 等.聚氨基酸復合納米羥基磷灰石的體內生物相容性實驗研究.中國矯形外科雜志, 2010, 18(21): 1809-1813.
23. 代震宇, 李軍, 趙增輝, 等.納米羥基磷灰石/聚氨基酸復合材料生物安全性評價.第三軍醫大學學報, 2010, 32(21): 2294-2299.
24. 李軍, 代震宇, 趙增輝, 等.納米羥基磷灰石/聚氨基酸復合材料的生物相容性研究.重慶醫科大學學報, 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. 趙增輝, 蔣電明, 蘇保, 等.復合骨修復材料——聚氨基酸/硫酸鈣的生物相容性研究.功能材料, 2011, 42(5): 807-811.
27. 鄒昌, 張帥, 段宏, 等.注射型可吸收聚氨基酸/硫酸鈣復合材料動物體內的安全及組織相容性.中國組織工程研究, 2012, 16(8): 1391-1395.
28. 姜勇, 張帥, 周勇, 等.注射型可吸收聚氨基酸/硫酸鈣復合材料動物體內降解吸收及促成骨作用.中國組織工程研究, 2012, 16(12): 2091-2094.
29. 嚴永剛, 王鵬, 李鴻, 等.可控降解多元氨基酸共聚物-有機鈣/磷鹽填充型復合骨植入物及制備方法.中國: CN104307048A. 2015-01-28.
30. 薛有地. PAA/n-HA/CS Cage在山羊腰椎椎間融合中應用的實驗研究.成都:四川大學, 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. 桑裴銘, 張明, 陳斌輝, 等.納米羥基磷灰石/聚酰胺66復合材料融合器行經椎間孔腰椎椎體間融合術的影像學研究.中國骨傷, 2014, 27(8): 654-657.
36. 龍厚清, 植山和正, 劉少喻, 等. Prospace融合器結合關節突融合在單節段經后路腰椎間融合術中的初步應用.中國修復重建外科雜志, 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

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