Neurosurgery Department, Novosibirsk Research Institute of Traumatology and Orthopaedics, Novosibirsk, Russian Federation
Project Management, Biorasi, Aventura, Florida, USA.
BMJ Open. 2021 Mar 5;11(3):e041134. doi: 10.1136/bmjopen-2020-041134.
Patients with symptomatic single-level combination of degenerative stenosis and low-grade spondylolisthesis are often treated by nerve root decompression and spinal fusion. The gold standard is traditional open decompression and fusion, but minimally invasive method is more and more prevailing. However, there is lack of high-quality studies comparing these two techniques in order to obtain the advantages and certain indications to use one of these methods. The current study includes clinical, safety and radiological endpoints to determine the effectiveness of minimally invasive decompression and fusion (MIS-TLIF) over the traditional open one (O-TLIF).
All patients aged 40-75 years with neurogenic claudication or bilateral radiculopathy caused by single-level combination of degenerative stenosis and low-grade spondylolisthesis, confirmed by MRI with these symptoms persisting for at least 3 months prior to surgery, are eligible. Patients will be randomised into MIS-TLIF or traditional O-TLIF. The primary outcome measure is Oswestry Disability Index at 3-month follow-up term. The secondary outcomes are patient-reported outcome measures by the number of clinical scales, radiological parameters including sagittal balance parameters, safety endpoints and cost-effectiveness of each method. All patients will be analysed preoperatively, as well as on the 14th day of hospital stay (or on the day of hospital discharge), 3 months, 6 months, 12 months and 24 months postoperatively. The study has the design of a parallel group to demonstrate the non-inferior clinical results of MIS-TLIF compared with the traditional O-TLIF.
The study will be performed according to Helsinki Declaration. The study protocol was approved by the Local Ethical Committee of Priorov National Medical Research Center of Traumatology and Orthopedics in August 2020. Preliminary and final results will be presented in peer-reviewed journals, especially orthopaedic and spine surgery journals, at national and international congresses.
NCT04594980.
有症状的单节段退变性狭窄和低度滑脱合并症的患者通常接受神经根减压和脊柱融合治疗。金标准是传统的开放性减压融合术，但微创方法越来越流行。然而，缺乏高质量的研究来比较这两种技术，以获得使用其中一种方法的优势和特定适应证。本研究包括临床、安全性和影像学终点，以确定微创减压融合术（MIS-TLIF）与传统开放性减压融合术（O-TLIF）相比的有效性。
所有年龄在 40-75 岁之间、有神经源性跛行或双侧根性病变的患者，这些症状由 MRI 证实，且在手术前至少持续 3 个月，都符合条件。患者将被随机分配到 MIS-TLIF 或传统 O-TLIF 组。主要终点是 3 个月随访时的 Oswestry 残疾指数。次要终点是患者报告的结果，包括临床量表的数量、包括矢状位平衡参数在内的影像学参数、安全性终点以及每种方法的成本效益。所有患者将在术前、住院第 14 天（或出院当天）、术后 3 个月、6 个月、12 个月和 24 个月进行分析。该研究采用平行组设计，旨在证明 MIS-TLIF 与传统 O-TLIF 相比具有非劣效的临床结果。
该研究将按照赫尔辛基宣言进行。研究方案于 2020 年 8 月获得 Priorov 国家创伤和矫形医学研究中心地方伦理委员会的批准。初步和最终结果将在同行评议期刊上发表，特别是在骨科和脊柱外科期刊上，并在国内外大会上展示。
NCT04594980。
