Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Change in Oswestry Disability Index (ODI)
研究概览
简要总结
There is a shallow learning curve with TELD (transforaminal endoscopic lumbar discectomy). The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 and ≤80 years;
- •typical clinical symptoms and consistent imaging evidence of mono-radiculopathy LDH; or single level LSS combined with disc herniation
- •recalcitrant pain despite proper conservative therapy (including analgesics, NSAIDs, corticoids infusion under CT guidance and physical therapy) for at least 3 months before surgery and/or neurological deficit in the territory of the irritated nerve root
- •VAS pain ≥ 6/10
- •Absence of significant instability;
排除标准
- •serious underlying disease or mental illnesses
- •severe central stenosis, cauda equina syndrome, spinal instability, active infection, and serious calcified fragments
- •previous lumbar treatment with spinal surgery, ozone intervention, or radiofrequency ablation
- •unwilling or unable to participate in treatment and complete follow-up
- •Multi-level disc pathology
- •MRC paresis <4/5
- •participation in another clinical trial
结局指标
主要结局
Change in Oswestry Disability Index (ODI)
时间窗: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
Change in Roland Morris Disability Questionnaire (RMDQ)
时间窗: Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively
This is a 24 item questionnaire. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability)
次要结局
- Leg Pain Numerical Rating Score (LPNRS)(Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively)
- Modified MacNab Criteria(Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively)
- Back Pain Numerical Rating Score (BPNRS)(Preoperatively. 6 weeks, 3 months, 6 months and 12 months post-operatively)
研究者
Remacle Thibault
Principal Investigator, MD, PhD, Neurosurgeon
Centre Hospitalier Régional de la Citadelle