Total laminectomy combined with lumbar pedicle screw fixation for treatment of lower back and leg pain in older adult patients with degenerative lumbar spinal stenosis: study protocol for a self-control trial and preliminary results

doi:10.3969/j.issn.2095-4344.0247

Abstract

Abstract:

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).

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Lumbar Vertebrae, Spinal Nerve Roots

CLC Number:

R318

Li Chun-liang, Guo Qiang, Qin Feng, Yan Wen-qi, Zhu Hai-yong, Wang Kai. Total laminectomy combined with lumbar pedicle screw fixation for treatment of lower back and leg pain in older adult patients with degenerative lumbar spinal stenosis: study protocol for a self-control trial and preliminary results [J]. Chinese Journal of Tissue Engineering Research, 2018, 22(15): 2345-2349.

Figures/Tables 1

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