"Radiological Analysis of MRI Images in Patients Treated With Minimally Invasive Microsurgical and Endoscopic Techniques: A Randomized Study Comparing the Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])
研究概览
简要总结
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are:
- Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD?
- Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD?
- Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies?
Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making.
Participants will:
- Undergo either FELD or MD surgery
- Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery)
- Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-85 years with symptoms of sciatica lasting more than 6 weeks
- •Shorter duration in cases where symptoms significantly impair normal functioning or in cases of muscle strength deficits
- •Symptoms correlate with MRI findings of lumbar spine pathology, showing the presence of intervertebral disc herniation (protrusion, extrusion, or sequestration) causing nerve root compression in the lumbar spine.
排除标准
- •Previous lumbar spine surgery in the lumbar-sacral region
- •MRI findings showing degenerative or stenotic spinal canal changes
- •Multi-level pathology where identification of the pain source is not possible
- •Pregnancy
研究组 & 干预措施
MD
microdiscectomy
干预措施: Microdiscectomy (Procedure)
结局指标
主要结局
Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months post-surgery
Description: The primary outcome measure will assess changes in back and leg pain intensity reported by patients using the Visual Analog Scale (VAS) at each follow-up. The reduction in pain scores will be compared between the FELD and MD groups to evaluate which technique provides superior pain relief over time.
次要结局
- Change in Functional Disability (measured by the Oswestry Disability Index [ODI])(Baseline, 1 month, 3 months, 6 months, 12 months post-surgery)
- Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI])(Baseline, 1 month, 3 months, 6 months, 12 months post-surgery)
- Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)(1 month, 3 months, 6 months, 12 months post-surgery)
- Time to Return to Work(Up to 12 months post-surgery)
研究者
Kajetan Latka
PhD, Deputy-Head Neurosurgery Department WSS Opole
University of Opole