NCT04594980已完成不适用
An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 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 decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75 years;
- •Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
- •Symptoms persisting for at least three months prior to surgery;
- •Given written Informed Consent Form;
- •Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
- •Oswestry Disability Index score of at least 40/100 at baseline;
排除标准
- •Bilateral foraminal stenosis requiring surgical decompression on both sides;
- •Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
- •More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
- •Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
- •Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- •Spondylolisthesis grade II or higher of any etiology;
- •Prior lumbar spinal fusion at any level;
- •Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
- •History or presence of any other major neurological disease or condition that may interfere with the study assessments;
- •Severe arterial insufficiency of the legs or other peripheral vascular disease;
- •Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
研究组 & 干预措施
Open TLIF
Other
Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.
干预措施: lumbar fusion (Procedure)
Minimally invasive TLIF
Other
Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.
干预措施: lumbar fusion (Procedure)
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. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active
次要结局
- Change from baseline in Clinical Global Impression Of Change (CGIC) scale(Through 2 years)
- Fusion rate success(12 months and 24 months post op)
- Reoperations rate(Through 2 years)
- Surgery duration(Day of surgery)
- Change from baseline in Numeric Pain Rating Score (NPRS)(Through 2 years)
- Pelvic Incidence(Through 2 years)
- Change from baseline in Pelvic Tilt(Through 2 years)
- Change from baseline in Sagittal Vertical Axis(Through 2 years)
- Adverse Events(Through 2 years)
- Change from baseline in Oswestry Disability Index (ODI)(Through 2 years)
- Change from baseline in Global Lordosis Angle(Through 2 years)
- Change from baseline in Segmental Lordosis(Through 2 years)
- Change from baseline in The Health Transition Item from SF-36 (HTI Item)(Through 2 years)
- Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).(Through 2 years)
- Change from baseline in Douleur Neuropathique 4 (DN4)(Through 2 years)
- Cost-effectiveness(14th day of hospital stay)
研究者
研究点 (1)
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