Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
Department of Spine Surgery, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
BMJ Open. 2024 Sep 25;14(9):e083786. doi: 10.1136/bmjopen-2023-083786.
Degenerative lumbar spinal stenosis is a common cause of low back or leg pain and disability in the elderly population. Patients with spinal stenosis who fail to respond to conservative treatment often require surgical interventions. Minimally invasive transforaminal lumbar interbody fusion (TLIF) with microscopic tubular technique (MT-TLIF) is a well-established procedure for lumbar spinal stenosis. Recently, a novel MIS technique, unilateral biportal endoscopic TLIF (UBE-TLIF), has been frequently performed to treat spinal stenosis. However, the efficacy and safety of using UBE-TLIF in this population have not been well examined.
A total of 96 patients with lumbar spinal stenosis will be randomly assigned to the UBE-TLIF group or the MT-TLIF group at a 1:1 ratio to receive UBE-TLIF or MT-TLIF treatment respectively. The primary outcome is the Oswestry Disability Index (ODI) score at 1 year after receiving the surgery. Secondary outcomes include the ODI scores at additional time points, Visual Analogue Scale score, 36-Item Short Form Survey questionnaire, EuroQol 5 Dimensions questionnaire, radiological measurements (disc height, lumbar lordosis angles and vertebral fusion rate) and general condition during hospitalisation.
This protocol is approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. All participants of the study will be well informed and written informed consent will be requested. Findings from this trial will be published in peer-reviewed publications, specifically in orthopedic and spinal journals. The completion of this study will not only examine the use of UBE-TLIF in lumbar spinal stenosis but also provide helpful clinical references.
ChiCTR2300069333.
退行性腰椎管狭窄症是老年人腰背或下肢疼痛和残疾的常见原因。对于保守治疗无效的脊柱狭窄症患者，通常需要手术干预。经皮微创经椎间孔腰椎体间融合术（TLIF）结合显微镜下管状技术（MT-TLIF）是治疗腰椎管狭窄症的成熟方法。最近，一种新的微创技术，单侧双通道内镜经椎间孔腰椎体间融合术（UBE-TLIF），已被频繁用于治疗脊柱狭窄症。然而，在该人群中使用 UBE-TLIF 的疗效和安全性尚未得到充分研究。
将 96 例腰椎管狭窄症患者按 1:1 比例随机分为 UBE-TLIF 组和 MT-TLIF 组，分别接受 UBE-TLIF 或 MT-TLIF 治疗。主要结局为术后 1 年的 Oswestry 功能障碍指数（ODI）评分。次要结局包括其他时间点的 ODI 评分、视觉模拟量表评分、36 项简明健康状况调查问卷、欧洲五维健康量表问卷、影像学测量（椎间盘高度、腰椎前凸角和椎体融合率）和住院期间的一般情况。
本方案已获得中山大学附属第三医院医学伦理委员会的批准。研究的所有参与者将被告知研究情况，并要求签署书面知情同意书。研究结果将发表在同行评议的出版物中，特别是在骨科和脊柱期刊上。本研究的完成不仅将检验 UBE-TLIF 在腰椎管狭窄症中的应用，还将为临床提供有价值的参考。
ChiCTR2300069333。
