NCT04408846撤回不适用
An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Surgery and Traditional Open Surgical Procedure
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan2 个研究点 分布在 1 个国家开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change from baseline in Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of minimally invasive surgical technique over the traditional open surgical procedure in patients with degenerative lumbar stenosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years;
- •Patient has single level degenerative lumbar spinal stenosis and an indication for a single level instrumented lumbar fusion for the treatment;
- •Symptoms persisting for at least three months prior to surgery;
- •Given written Informed Consent;
- •Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
排除标准
- •Prior lumbar spinal fusion at any level;
- •Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
- •Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
- •History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
- •Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
结局指标
主要结局
Change from baseline in Oswestry Disability Index (ODI)
时间窗: 3 months
To observe the change of ODI as compared to baseline through follow-up terms
次要结局
- Change from baseline in Douleur Neuropathique 4 (DN4)(Through 2 years)
- Change from baseline in Numeric Pain Rating Score (NPRS)(Through 2 years)
- Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D)(Through 2 years)
- Fusion rate success(12 months and 24 months post op)
- Change from baseline in The Health Transition Item from SF-36 (HTI Item)(Through 2 years)
- Adverse Events(Through 2 years)
- Change from baseline in Oswestry Disability Index (ODI)(Through 2 years)
- Change from baseline in Clinical Global Impression Of Change (CGIC) scale(Through 2 years)
- Cost-effectiveness(14th day of hospital stay)
研究者
研究点 (2)
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