NCT03908203撤回不适用
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
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10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
- Angle change at lumbar spine segment
研究概览
简要总结
This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.
The current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.
It is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given written Informed Consent;
- •Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;
- •Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;
- •Symptoms persisting for at least three months prior to surgery;
- •Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
排除标准
- •Lumbar deformation of non-degenerative etiology;
- •Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;
- •Patient that has already undergone a lumbar fusion surgery;
- •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
- •Concurrent participation in another clinical study that may confound study results.
结局指标
主要结局
Angle change at lumbar spine segment
时间窗: At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)
Angle between endplates at the treated level of lumbar spine
次要结局
- Surgery duration(Day of surgery)
- Improvement of Visual analog scale (VAS) back pain intensity(3, 6, 12 months)
- Sagittal balance parameters(At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months)
- Improvement of Visual analog scale (VAS) leg pain intensity(3, 6, 12 months)
- Improvement of Oswestry Disability Index (ODI)(3, 6, 12 months)
- Fusion rate success(12 months)
- Range of Motion(At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months)
- Disc height(At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months)
- Blood loss(Day of surgery)
研究者
研究点 (2)
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