改良后路椎体间融合联合骨水泥强化治疗老年退行性腰椎滑脱症:自身对照临床试验方案
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摘要
背景:经后路腰椎椎体间融合是治疗老年退行性腰椎滑脱症的主要修复方法,但对于老年骨质疏松患者,单靠钉棒系统固定容易脱位,椎体松动发生率高,不能达到有效坚强内固定效果。目的:试验拟采用改良后路椎体间融合联合骨水泥强化的方法治疗老年退行性腰椎滑脱症,以增加椎体稳定性,使固定物更加牢固,更有利于术后运动功能恢复。方法:纳入中国青海大学附属医院骨科就诊的老年退行性腰椎滑脱症患者113例,年龄65-70岁,性别不限,采用改良后路椎体间融合联合骨水泥强化的方法进行修复,随访时间为术后4,14个月。研究的主要结局指标为术后14个月Oswestry功能障碍指数评分优良率评估患者运动功能恢复情况;次要结局指标为术前,术后4个月Oswestry功能障碍指数评分优良率,术前,术后4,14个月目测类比评分、腰椎椎间隙高度、椎间孔高度、腰椎滑脱距离和角度比较,术后4,14个月术后不良反应发生率、椎体融合成功率、腰椎再次滑脱发生率。试验经青海大学附属医院医学伦理委员会批准(审批号:QHY023G)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对试验方案和过程均知情同意,并签署知情同意书。试验设计时间为2017年10月,试验于2018年6月开始进行患者招募及数据收集,2018年12月招募结束,2020年1月进行结果指标分析,2020年2月试验完成。文章结果将以科学会议报告,或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号:Chi CTR1800015335),注册方案版本号1.0。讨论:试验主要观察改良后路椎体间融合联合骨水泥强化治疗老年退行性腰椎滑脱症有效,结果是否安全可靠。
BACKGROUND: Posterior lumbar interbody fusion is the main repair method for senile degenerative lumbar spondylolisthesis. For elderly patients with osteoporosis, single screw rod system fixation regularly results in dislocation. The incidence of implant loosening is high, and therefore, effective internal fixation is not achieved. OBJECTIVE: This study will use the modified posterior lumbar interbody fusion procedure combined with bone cement augmentation for the treatment of senile degenerative lumbar spondylolisthesis so as to increase the stability of the vertebral body, make the fixator firm, and to maximize the recovery of postoperative motor function. METHODS: Totally 113 patients with senile degenerative lumbar spondylolisthesis, aged 65-70 years, irrespective of sex, will be recruited from the Department of Orthopedics of Affiliated Hospital of Qinghai University of China. The patients will be treated with modified posterior lumbar interbody fusion combined with bone cement augmentation. Follow-up will be performed at 3 and 12 months. The primary outcome measure is recovery of motor function as indicated by the postoperative Oswestry Disability Index score at 12 months. The secondary outcome measures are the change in the rate of excellent and good Oswestry Disability Index scores(comparing preoperative scores with the 4-month postoperative scores), Visual Analogue Scale scores, intervertebral space height, foraminal height, the preoperative and 4 and 14 months postoperative slip distance and slip angle, incidence of adverse reactions, success rate of vertebral fusion, and incidence of secondary slip 4 and 14 months postoperatively. This trial has been approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China(approval number: QHY023 G). The study protocol will be proformed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in October 2017. The recruitment of subjects and data collection will begin in June 2018. The recruitment will be finished in December 2018. Outcome measures will be analyzed in January 2020. This trial will be completed in February 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 number: Chi CTR1800015335). Protocol version(1.0). DISCUSSION: This trial aims to observe the efficacy of modified posterior lumbar interbody fusion combined with bone cement augmentation in the treatment of senile degenerative lumbar spondylolisthesis and to validate whether the procedure is safe and reliable.
BACKGROUND: Posterior lumbar interbody fusion is the main repair method for senile degenerative lumbar spondylolisthesis. For elderly patients with osteoporosis, single screw rod system fixation regularly results in dislocation. The incidence of implant loosening is high, and therefore, effective internal fixation is not achieved. OBJECTIVE: This study will use the modified posterior lumbar interbody fusion procedure combined with bone cement augmentation for the treatment of senile degenerative lumbar spondylolisthesis so as to increase the stability of the vertebral body, make the fixator firm, and to maximize the recovery of postoperative motor function. METHODS: Totally 113 patients with senile degenerative lumbar spondylolisthesis, aged 65-70 years, irrespective of sex, will be recruited from the Department of Orthopedics of Affiliated Hospital of Qinghai University of China. The patients will be treated with modified posterior lumbar interbody fusion combined with bone cement augmentation. Follow-up will be performed at 3 and 12 months. The primary outcome measure is recovery of motor function as indicated by the postoperative Oswestry Disability Index score at 12 months. The secondary outcome measures are the change in the rate of excellent and good Oswestry Disability Index scores(comparing preoperative scores with the 4-month postoperative scores), Visual Analogue Scale scores, intervertebral space height, foraminal height, the preoperative and 4 and 14 months postoperative slip distance and slip angle, incidence of adverse reactions, success rate of vertebral fusion, and incidence of secondary slip 4 and 14 months postoperatively. This trial has been approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China(approval number: QHY023 G). The study protocol will be proformed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. This trial was designed in October 2017. The recruitment of subjects and data collection will begin in June 2018. The recruitment will be finished in December 2018. Outcome measures will be analyzed in January 2020. This trial will be completed in February 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 number: Chi CTR1800015335). Protocol version(1.0). DISCUSSION: This trial aims to observe the efficacy of modified posterior lumbar interbody fusion combined with bone cement augmentation in the treatment of senile degenerative lumbar spondylolisthesis and to validate whether the procedure is safe and reliable.
引文
[1]Ilves O,H?kkinen A,Dekker J,et al.Quality of life and disability:can they be improved by active postoperative rehabilitation after spinal fusion surgery in patients with spondylolisthesis?Arandomised controlled trial with 12-month follow-up.Eur Spine J.2017;26(3):777-784.
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[3]Ghogawala Z,Dziura J,Butler WE,et al.Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis.N Engl JMed.2016;374(15):1424-1434.
[4]Siewe J,Bredow J,Oppermann J,et al.Evaluation of efficacy of a new hybrid fusion device:a randomized,two-centre controlled trial.BMC Musculoskelet Disord.2014;15:294.
[5]Challier V,Boissiere L,Obeid I,et al.One-level lumbar degenerative spondylolisthesis and posterior approach:is transforaminal lateral interbody fusion mandatory?A randomized controlled trial with 2-year follow-up.Spine(Phila Pa 1976).2017;42(8):531-539.
[6]Endler P,Ekman P,M?ller H,et al.Outcomes of posterolateral fusion with and without instrumentation and of interbody fusion for isthmic spondylolisthesis:a prospective study.J Bone Joint Surg Am.2017;99(9):743-752.
[7]Lee GW,Ahn MW.Comparative study of cortical bone trajectory-pedicle screw(cortical screw)versus conventional pedicle screw in single-level posterior lumbar interbody fusion:a2-year post hoc analysis from prospectively randomized data.World Neurosurg.2018;109:e194-e202.
[8]Song D,Chen Z,Song D,et al.Comparison of posterior lumbar interbody fusion(PLIF)with autogenous bone chips and PLIF with cage for treatment of double-level isthmic spondylolisthesis.Clin Neurol Neurosurg.2015;138:111-116.
[9]Yang EZ,Xu JG,Liu XK,et al.An RCT study comparing the clinical and radiological outcomes with the use of PLIF or TLIFafter instrumented reduction in adult isthmic spondylolisthesis.Eur Spine J.2016;25(5):1587-1594.
[10]Litrico S,Recanati G,Gennari A,et al.Single-use instrumentation in posterior lumbar fusion could decrease incidence of surgical site infection:a prospective bi-centric study.Eur J Orthop Surg Traumatol.2016;26(1):21-26.
[11]Lee GW,Son JH,Ahn MW,et al.The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion:a prospective randomized noninferiority trial.Spine J.2015;15(7):1519-1526.
[12]Lee GW,Lee SM,Ahn MW,et al.Comparison of posterolateral lumbar fusion and posterior lumbar interbody fusion for patients younger than 60 years with isthmic spondylolisthesis.Spine(Phila Pa 1976).2014;39(24):E1475-1480.
[13]Gertzbein SD,Betz R,Clements D,et al.Semirigid instrumentation in the management of lumbar spinal conditions combined with circumferential fusion.A multicenter study.Spine(Phila Pa 1976).1996;21(16):1918-1925.
[14]杨惠林,朱晓宇,王根林.退行性腰椎滑脱症[C].2007全国腰椎退行性疾患学术论坛,2007.
[15]张智海,刘忠厚,李娜,等.中国人骨质疏松症诊断标准专家共识(第三稿·2014版)[J].中国骨质疏松杂志,2014,19(9):1007-1010.
[16]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.
[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]王大林,徐杰,王黎明,等.改良后路椎体间融合联合骨水泥强化术治疗老年腰椎滑脱症的效果观察[J].中国脊柱脊髓杂志,2013,23(1):30-36.
[2]Lindb?ck Y,Tropp H,Enthoven P,et al.PREPARE:Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder:a randomized controlled trial protocol.BMCMusculoskelet Disord.2016;17:270.
[3]Ghogawala Z,Dziura J,Butler WE,et al.Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis.N Engl JMed.2016;374(15):1424-1434.
[4]Siewe J,Bredow J,Oppermann J,et al.Evaluation of efficacy of a new hybrid fusion device:a randomized,two-centre controlled trial.BMC Musculoskelet Disord.2014;15:294.
[5]Challier V,Boissiere L,Obeid I,et al.One-level lumbar degenerative spondylolisthesis and posterior approach:is transforaminal lateral interbody fusion mandatory?A randomized controlled trial with 2-year follow-up.Spine(Phila Pa 1976).2017;42(8):531-539.
[6]Endler P,Ekman P,M?ller H,et al.Outcomes of posterolateral fusion with and without instrumentation and of interbody fusion for isthmic spondylolisthesis:a prospective study.J Bone Joint Surg Am.2017;99(9):743-752.
[7]Lee GW,Ahn MW.Comparative study of cortical bone trajectory-pedicle screw(cortical screw)versus conventional pedicle screw in single-level posterior lumbar interbody fusion:a2-year post hoc analysis from prospectively randomized data.World Neurosurg.2018;109:e194-e202.
[8]Song D,Chen Z,Song D,et al.Comparison of posterior lumbar interbody fusion(PLIF)with autogenous bone chips and PLIF with cage for treatment of double-level isthmic spondylolisthesis.Clin Neurol Neurosurg.2015;138:111-116.
[9]Yang EZ,Xu JG,Liu XK,et al.An RCT study comparing the clinical and radiological outcomes with the use of PLIF or TLIFafter instrumented reduction in adult isthmic spondylolisthesis.Eur Spine J.2016;25(5):1587-1594.
[10]Litrico S,Recanati G,Gennari A,et al.Single-use instrumentation in posterior lumbar fusion could decrease incidence of surgical site infection:a prospective bi-centric study.Eur J Orthop Surg Traumatol.2016;26(1):21-26.
[11]Lee GW,Son JH,Ahn MW,et al.The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion:a prospective randomized noninferiority trial.Spine J.2015;15(7):1519-1526.
[12]Lee GW,Lee SM,Ahn MW,et al.Comparison of posterolateral lumbar fusion and posterior lumbar interbody fusion for patients younger than 60 years with isthmic spondylolisthesis.Spine(Phila Pa 1976).2014;39(24):E1475-1480.
[13]Gertzbein SD,Betz R,Clements D,et al.Semirigid instrumentation in the management of lumbar spinal conditions combined with circumferential fusion.A multicenter study.Spine(Phila Pa 1976).1996;21(16):1918-1925.
[14]杨惠林,朱晓宇,王根林.退行性腰椎滑脱症[C].2007全国腰椎退行性疾患学术论坛,2007.
[15]张智海,刘忠厚,李娜,等.中国人骨质疏松症诊断标准专家共识(第三稿·2014版)[J].中国骨质疏松杂志,2014,19(9):1007-1010.
[16]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.
[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]王大林,徐杰,王黎明,等.改良后路椎体间融合联合骨水泥强化术治疗老年腰椎滑脱症的效果观察[J].中国脊柱脊髓杂志,2013,23(1):30-36.