Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- Reherniation rate
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 observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .
It is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years;
- •Single level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;
- •Radicular leg pain with or without back pain;
- •Symptoms persisting for at least four weeks 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;
- •Visual Analogue Scale score at least 40/100 at baseline.
排除标准
- •More than one symptomatic level requiring multilevel surgical decompression
- •Stenosis any etiology at the same level;
- •Spondylolisthesis any etiology at the same level;
- •Prior lumbar spinal surgery 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
- •Concurrent participation in another clinical study that may confound study results.
结局指标
主要结局
Reherniation rate
时间窗: at 3 years follow-up term postoperatively
Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side
次要结局
- Improvement of Oswestry Disability Index (ODI)(6, 12, 18, 24, 30, 36 months follow up)
- Change from baseline in EQ-5D (EuroQl - 5 dimensional)(6, 12, 18, 24, 30, 36 months follow up)
- Improvement of Visual analog scale (VAS) leg pain intensity(6, 12, 18, 24, 30, 36 months follow up)
- HTI Item (from SF-36)(6, 12, 18, 24, 30, 36 months follow up)