A COMPARATIVE STUDY ON EARLY CLINICAL OUTCOME BETWEEN Coflex AND KMC FOR SINGLE-LEVEL DEGENERATIVE LUMBAR SPINAL DISORDERS_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

YAOYicun ,  LIANGWeiguo , WUJingfeng , ZHOUZiqiang , CHENZhiguang , YEShaohui , LIFengsheng , YEDongping

Department of Orthopedics, Fourth Affiliated Hospital of Jinan University, Guangzhou Red-Cross Hospital, Guangzhou Guangdong, 510220, P. R. China;

Corresponding author：

LIANGWeiguo, Email: shihonghuiyiyuan@163.com

Keywords：

Degeneration lumbar spinal disorders; Non-fusion dynamic fixation; Internal fixation

DOI：

10.7507/1002-1892.20140107

Video：

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Objective To compare the effectiveness and radiological changes between KMC interspinous dynamic reconstruction and Coflex for degenerative lumbar spinal disorders and evaluate the clinical outcome of the KMC interspinous dynamic internal fixation for degenerative lumbar spinal disorders. Methods A randomized controlled double-blind trial was conducted. Thirty-three patients with degenerative lumbar spinal disorders were divided into 2 groups between May 2011 and July 2012, 19 patients received Coflex treatment (group A), and 14 patients received KMC (group B). Single Coflex or KMC fixation was used. There was no significant difference in age, gender, disease duration, affected segment, and disease diagnosis between 2 groups (P>0.05). The Oswestry disability index (ODI) score and visual analogue scale (VAS) score were used to evaluate the effectiveness. The anterior disc height, middle disc height, posterior disc height, and foramen intervertebral height and width of operated segment were measured and compared between at preoperation and last follow-up on the X-ray films. Range of motion (ROM) of operated segment and adjacent segment was measured. Results There was no significant difference in operation time, intraoperative blood loss, postoperative recovery time, and hospitalization time between 2 groups (P>0.05). The patients were followed up 12-24 months (mean, 16.2 months) in group A and 12-26 months (mean, 17.9 months) in group B. No shift, loosening, or breaking of internal fixation occurred. The ODI score and VAS score were significantly decreased at last follow-up when compared with preoperative scores (P<0.05); there was no significant difference in the ODI score and VAS score at preoperation and last follow-up, and in improvement rate at last follow-up between 2 groups (P>0.05). The middle disc height and posterior disc height, and foramen intervertebral height and width were significantly increased when compared with preoperative ones (P<0.05), while there was no significant difference in anterior disc height (P>0.05). At last follow-up, ROM of the operated segments was significantly improved when compared with preoperative one in 2 groups (P<0.05), but no significant difference was found at the upper adjacent level (P>0.05). There was no significant difference in ROM of the operated segment and upper adjacent segment between 2 groups at preoperation and last follow-up (P>0.05). Conclusion The early effectiveness is satisfactory to treat degeneration lumbar spinal disorders with KMC interspinous dynamic internal fixation.

Citation： YAOYicun, LIANGWeiguo, WUJingfeng, ZHOUZiqiang, CHENZhiguang, YEShaohui, LIFengsheng, YEDongping. A COMPARATIVE STUDY ON EARLY CLINICAL OUTCOME BETWEEN Coflex AND KMC FOR SINGLE-LEVEL DEGENERATIVE LUMBAR SPINAL DISORDERS. Chinese Journal of Reparative and Reconstructive Surgery, 2014, 28(4): 474-479. doi: 10.7507/1002-1892.20140107 Copy

1.	Smith LJ, Nerurkar NL, Choi KS, et al. Degeneration and regeneration of the intervertebral disc:lessons from development. Dis Model Mech, 2011, 4(1):31-41.
2.	Sanderson KB, Roditi D, George SZ, et al. Investigating patient expectations and treatment outcome in a chronic low back pain population. J Pain Res, 2012, 5:15-22.
3.	Bridwell KH, Sedgewick TA, O'Brien MF, et al. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. J Spinal Disord, 1993, 6(6):461-472.
4.	Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976), 1999, 24(17):1820-1832.
5.	Kroppenstedt S, Gulde M, Schönmayr R. Radiological comparison of instrumented posterior lumbar interbody fusion with one or two closed-box plasmapore coated titanium cages:follow-up study over more than seven years. Spine (Phila Pa 1976), 2008, 33(19):2083-2088.
6.	Chou WY, Hsu CJ, Chang WN, et al. Adjacent segment degeneration after lumbar spinal posterolateral fusion with instrumentation in elderly patients. Arch Orthop Trauma Surg, 2002, 122(1):39-43.
7.	Kong DS, Kim ES, Eoh W. One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci, 2007, 22(2):330-335.
8.	Kim JW, Park HC, Yoon SH, et al. A multi-center clinical study of posterior lumbar interbody fusion with the expandable stand-alone cage (Tyche(R) Cage) for degenerative lumbar spinal disorder. J Korean Neurosurg Soc, 2007, 42(4):251-257.
9.	Schulte TL, Leistra F, Bullmann V, et al. Disc height reduction in adjacent segments and clinical outcome 10 years after lumbar 360 degrees fusion. Eur Spine J, 2007, 16(12):2152-2158.
10.	Tsai KJ, Murakami H, Lowery GL, et al. A biomechanical evaluation of an interspinous device (Coflex) used to stabilize the lumbar spine. J Surg Orthop Adv, 2006, 15(3):167-172.
11.	Wilke HJ, Drumm J, Haussler K, et al. Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure. Eur Spine J, 2008, 17(8):1049-1056.
12.	张国威. 棘突间Coflex装置与后路椎间融合治疗腰椎间盘退行性疾病的对比研究. 广州:暨南大学, 2010.
13.	毛仲轩. 棘突间稳定装置Coflex-(TM)的生物力学和临床应用研究. 广州:南方医科大学, 2009.
14.	刘进, 刘浩, 李涛, 等. 单节段Coflex棘突间动力重建与后路360°植骨融合治疗腰椎退变性疾病的对比研究. 中国修复重建外科杂志, 2011, 25(6):693-698.
15.	Yong SB, Yoon H, Poong GA, et al. Interspinous implantation for degenerative lumbar spine:clinical and radiological outcome at 3-year follow up. Kor J Spine, 2008, 5(3):130-135.
16.	Farfan HP. Mechanical disorders of the low back. Philadelphia:Lea and Febiger, 1973:37-40.
17.	Dall BE, Rowe DE. Degenerative spondylolisthesis. Its surgical management. Spine (Phila Pa 1976), 1985, 10(7):668-672.
18.	胥少汀, 葛宝丰, 徐印坎. 实用骨科学. 4版. 北京:人民军医出版社, 2012:1066-1069.

1. Smith LJ, Nerurkar NL, Choi KS, et al. Degeneration and regeneration of the intervertebral disc:lessons from development. Dis Model Mech, 2011, 4(1):31-41.
2. Sanderson KB, Roditi D, George SZ, et al. Investigating patient expectations and treatment outcome in a chronic low back pain population. J Pain Res, 2012, 5:15-22.
3. Bridwell KH, Sedgewick TA, O'Brien MF, et al. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. J Spinal Disord, 1993, 6(6):461-472.
4. Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976), 1999, 24(17):1820-1832.
5. Kroppenstedt S, Gulde M, Schönmayr R. Radiological comparison of instrumented posterior lumbar interbody fusion with one or two closed-box plasmapore coated titanium cages:follow-up study over more than seven years. Spine (Phila Pa 1976), 2008, 33(19):2083-2088.
6. Chou WY, Hsu CJ, Chang WN, et al. Adjacent segment degeneration after lumbar spinal posterolateral fusion with instrumentation in elderly patients. Arch Orthop Trauma Surg, 2002, 122(1):39-43.
7. Kong DS, Kim ES, Eoh W. One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci, 2007, 22(2):330-335.
8. Kim JW, Park HC, Yoon SH, et al. A multi-center clinical study of posterior lumbar interbody fusion with the expandable stand-alone cage (Tyche(R) Cage) for degenerative lumbar spinal disorder. J Korean Neurosurg Soc, 2007, 42(4):251-257.
9. Schulte TL, Leistra F, Bullmann V, et al. Disc height reduction in adjacent segments and clinical outcome 10 years after lumbar 360 degrees fusion. Eur Spine J, 2007, 16(12):2152-2158.
10. Tsai KJ, Murakami H, Lowery GL, et al. A biomechanical evaluation of an interspinous device (Coflex) used to stabilize the lumbar spine. J Surg Orthop Adv, 2006, 15(3):167-172.
11. Wilke HJ, Drumm J, Haussler K, et al. Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure. Eur Spine J, 2008, 17(8):1049-1056.
12. 张国威. 棘突间Coflex装置与后路椎间融合治疗腰椎间盘退行性疾病的对比研究. 广州:暨南大学, 2010.
13. 毛仲轩. 棘突间稳定装置Coflex-(TM)的生物力学和临床应用研究. 广州:南方医科大学, 2009.
14. 刘进, 刘浩, 李涛, 等. 单节段Coflex棘突间动力重建与后路360°植骨融合治疗腰椎退变性疾病的对比研究. 中国修复重建外科杂志, 2011, 25(6):693-698.
15. Yong SB, Yoon H, Poong GA, et al. Interspinous implantation for degenerative lumbar spine:clinical and radiological outcome at 3-year follow up. Kor J Spine, 2008, 5(3):130-135.
16. Farfan HP. Mechanical disorders of the low back. Philadelphia:Lea and Febiger, 1973:37-40.
17. Dall BE, Rowe DE. Degenerative spondylolisthesis. Its surgical management. Spine (Phila Pa 1976), 1985, 10(7):668-672.
18. 胥少汀, 葛宝丰, 徐印坎. 实用骨科学. 4版. 北京:人民军医出版社, 2012:1066-1069.

Chinese Journal of Reparative and Reconstructive Surgery

A COMPARATIVE STUDY ON EARLY CLINICAL OUTCOME BETWEEN Coflex AND KMC FOR SINGLE-LEVEL DEGENERATIVE LUMBAR SPINAL DISORDERS

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