摘要
背景:老年退行性腰椎管狭窄症主要的临床表现是由于神经根受压而导致患者出现腰腿痛。传统的全椎板切除修复虽能迅速改善患者的症状,但是由于脊柱缺乏稳定性,易出现退变性滑脱,导致疗效不佳,不良反应较多。目的:设想采用全椎板切除联合椎弓根钉内固定修复老年退行性腰椎管狭窄症,有效减轻神经根受压而导致患者出现腰腿疼痛,可提高脊柱稳定性,减少术后不良反应。方法:研究为前瞻性、单中心、自身对照临床试验。试验将纳入来自青海省人民医院骨科的老年退行性腰椎管狭窄症患者160例,均采用全椎板切除联合椎弓根钉内固定治疗,术后进行3,6,9,12个月随访。结果与结论:研究的主要结局指标为术后12个月日本矫形科学学会(JOA)下腰痛评分改善率变化评价患者腰腿疼痛的改善情况;次要结局指标以JOA下腰痛评分变化、椎管直径变化及腰椎CT形态变化,术后不良反应发生率。前期71例患者术后3个月的预试验结果显示,术后3个月JOA下腰痛评分及椎管直径较术前显著升高(P<0.05)。试验以期证实采用全椎板切除脊柱内固定修复老年退行性腰椎管狭窄症患者,可以快速缓解患者腰腿疼痛症状并保证脊柱的稳定性,安全可靠。试验经青海省人民医院医学伦理委员会批准(审批单位:青海省人民医院,审批号:QHY201602G)。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12月,试验于2018年8月至开始进行患者招募及数据收集,2019年10月进行结果指标分析,2019年12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。试验的方案版本号(1.0)。试验已在中国临床试验注册中心注册(注册号:Chi CTR1800014726)。
BACKGROUND： Senile degenerative lumbar spinal stenosis typically manifests clinically as lower back and leg pain caused by compression of the nerve root. Conventional total laminectomy for degenerative lumbar spinal stenosis can quickly alleviate a patient＇s symptoms, but produces an unsatisfactory therapeutic effect because of spinal instability caused by degenerative spondylolisthesis, and also has many adverse reactions. OBJECTIVE： The purpose of this study is to investigate whether total laminectomy combined with lumbar pedicle screw fixation for treatment of senile degenerative lumbar spinal stenosis can effectively reduce lower back and leg pain caused by compression of the nerve root, increase lumbar spine stability, and reduce adverse reactions. METHODS： A prospective, single-center, self-control, interventional trial. One hundred and sixty older adult patients with degenerative lumbar spinal stenosis who will receive treatment at the Department of Orthopedics, Qinghai Provincial People＇s Hospital, China will be included in this study. All patients will undergo total laminectomy combined with lumbar pedicle screw fixation, with follow-up at 3, 6, 9, and 12 months post-surgery. RESULTS AND CONCLUSION： The primary outcome measure of this study is recovery rate in Japanese Orthopedic Society （JOA） score at 12 months post-surgery, which is used to evaluate improvements in patients lower back and leg pain. Secondary outcome measures of this study include changes in JOA score, spinal canal diameter, lumbar spine morphology displayed on computed tomography images, and incidence of adverse events post-surgery. Results of a preliminary study involving 71 older adult patients with degenerative lumbar spinal stenosis who received the same treatment showed that at 3 months post-surgery, JOA score and spinal canal diameter were significantly increased compared with before surgery （P 〈 0.05）. Findings from this study may provide clinical evidence supporting that total laminectomy combined with lumbar pedicle screw fixation is a safe and reliable method for treatment of senile degenerative lumbar spinal stenosis because it rapidly alleviates lower back and leg pain and provides spine stability. This study was approved by Medical Ethics Committee of Qinghai Provincial People＇s Hospital of China（approval No.QHY201602G）.This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association.Participants provided signed informed consent prior to participation in the study.This study was designed in December 2017. Patient recruitment and data collection will begin in August 2018. Data analysis will be performed in October 2019. The study will be completed in December 2019. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. The version of this study protocol is （1.0）. This trial was registered with the Chinese Clinical Trial Registry （registration number： ChiCTR1800014726）.
作者
李春亮
郭强
秦凤
严文琪
朱海勇
王凯
Li Chun-liang;Guo Qiang;Qin Feng;Yan Wen-qi;Zhu Hai-yong;Wang Kai(Department of Orthopedics, Qinghai Provincial People’s Hospital, Xining 810007, Qinghai Province, China;Department of Endocrinology, Affiliated Hospital of Qinghai University, Xining 810001, Qinghai Province, China)
出处
《中国组织工程研究》
CAS
北大核心
2018年第15期2345-2349,共5页
Chinese Journal of Tissue Engineering Research
