Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial

BMC Musculoskeletal Disorders

Hong-Jae Lee¹  Dong-Hwa Heo²  Jin-Sung Kim³  Jae-Won Jang⁴  Jin-Sub Hwang⁴  Jun-Young Kim⁴  Dong-Geun Lee⁴  Choon-Keun Park⁴  Kwang-Sup Song⁵  Si-Young Park⁶  Taewook Kang⁶  Min-Seok Kang⁷  Chang-Won Park⁸  Ki-Han You⁸  Hyun-Jin Park⁸  Joon-Hyeok Yoon⁸  Sang-Min Park⁹  Ho-Joong Kim⁹ 

[1] Department of Neurosurgery, Daejeon St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea;Department of Neurosurgery, Endoscopic Spine Surgery Center, Seoul Bumin Hospital, Seoul, South Korea;Department of Neurosurgery, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea;Department of Neurosurgery, The Leon Wiltse Memorial Hospital, Suwon, South Korea;Department of Orthopaedic Surgery, Chung-Ang University, College of Medicine, Seoul, South Korea;Department of Orthopaedics, Korea University College of Medicine, Anam Hospital, Seoul, South Korea;Department of Orthopedic Surgery, Endoscopic Spine Surgery Center, Bumin Hospital, Seoul, South Korea;Department of Orthopedic Surgery, Spine Center, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 1, Singil-ro, Yeongdeungpo-gu, 07441, Seoul, South Korea;Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea;

关键词: Lumbar spinal stenosis;    Biportal endoscopic spine surgery;    Decompressive laminectomy;   

DOI  :  10.1186/s12891-021-04959-2

来源: Springer

【 摘 要 】

BackgroundRecent studies on biportal endoscopic spine surgery in patients with lumbar spinal stenosis have reported good clinical results. However, these studies have been limited by the small sample sizes and use of a retrospective study design. Therefore, we aim to compare the efficacy and safety of biportal endoscopic decompressive laminectomy with those of conventional decompressive laminectomy in a multicenter, prospective, randomized controlled trial.MethodsThis study will include 120 patients (60 per group, aged 20–80 years) with 1- or 2-level lumbar spinal stenosis, who will be recruited from six hospitals. The study will be conducted from July 2021 to December 2024. The primary outcome (Oswestry Disability Index at 12 months after surgery) will be evaluated through a modified intention-to-treat method. The secondary outcomes will include the following: visual analog scale score for low back and lower extremity radiating pain, EuroQol 5-dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scars, and some surgery-related variables. Radiographic outcomes will be analyzed using magnetic resonance imaging or computed tomography. All outcomes will be evaluated before the surgery and at 2 weeks, 3 months, 6 months, and 12 months postoperatively. This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for reporting of clinical trial protocols.DiscussionIt is hypothesized that the efficacy and safety of biportal endoscopic and conventional decompressive laminectomy will be comparable in patients with lumbar spinal stenosis. The results of this trial will provide a high level of evidence for the efficacy and safety of the biportal endoscopic technique in patients with lumbar spinal stenosis and facilitate the development of clinical practice guidelines. Furthermore, the results of this study may indicate the feasibility of the biportal endoscopic technique for other types of spinal surgery.Trial registrationThe ENDO-B trial is registered at Clinical Research Information Service (CRIS, cris.nih.go.kr) (KCT0006057; April 52,021).

【 授权许可】

CC BY