Author:
Pan Weicheng,Jiang Jialin,Zhang Weihang,Mei Zijian,Sun Kaiqiang,Zheng Bing,Meng Yake,Bai Yushu,He Zhimin,Shi Jiangang,Guo Yongfei
Abstract
Abstract
Background
New-onset neurological symptoms such as numbness and pain in lower extremities might appear immediately after conventional lumbar interbody fusion (LIF) surgery performed in patients with lumbar spinal stenosis.
Methods and analysis
This is a multicenter, randomized, open-label, parallel-group, active-controlled trial investigating the clinical outcomes of modified LIF sequence versus conventional LIF sequence in treating patients with lumbar spinal stenosis. A total of 254 eligible patients will be enrolled and randomized in a 1:1 ratio to either modified LIF sequence or conventional LIF sequence group. The primary outcome measure is the perioperative incidence of new-onset lower extremity neurological symptoms, including new adverse events of pain, numbness, and foot drop of any severity. Important secondary endpoints include visual analogue scale (VAS) pain score and lumbar Japanese Orthopaedic Association (JOA) recovery rate. Other safety endpoints will also be evaluated. The safety set used for safety data analysis by the actual surgical treatment received and the full analysis set for baseline and efficacy data analyses according to the intent-to-treat principle will be established as the two analysis populations in the study.
Conclusion
This study is designed to investigate the clinical outcomes of modified LIF sequences in patients with lumbar spinal stenosis. It aims to provide clinical evidence that the modified “fixation-fusion” sequence of LIF surgery is effective in treating lumbar spinal stenosis.
Trial registration
http://www.chictr.org.cn/index.aspx ID: ChiCTR2100048507.
Funder
the Innovative Clinical Research Project of Shanghai Changzheng Hospital
Publisher
Springer Science and Business Media LLC
Subject
Orthopedics and Sports Medicine,Rheumatology