Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Oswestry disability index (ODI) score post-operation at 12months
研究概览
简要总结
Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study
详细描述
Backgrounds :
Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.
Objectives :
To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis
Methods :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80
- •Persist radiculopathy and sciatica pain
- •Patient that was diagnosed Stable lumbar foraminal stenosis
- •Failed conservative for at least 6 months
- •Patients who willing to join the study
排除标准
- •Patients with unstable lumbar foraminal stenosis
- •Patient with spine infection or tumor or fracture
- •Patient with BMD less than -2.5 or osteopenia
- •Patient with inflammatory joint diseases who on steroids
- •Patient who has undergo with surgery that inserted metals in back
- •Unable to answer questionnaires
- •Cannot tolerate surgery due to severe medical comorbidities
结局指标
主要结局
Oswestry disability index (ODI) score post-operation at 12months
时间窗: 12 months
Oswestry disability index (ODI) questionnaire at 12 months postoperative. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly.
次要结局
- Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months(6week, 3 months and 6 months)
- visual analog scale (VAS) of pain both leg and back(1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months)
- estimated blood loss (EBL)(perioperation)
- operative time(perioperation)
- length of hospital stay(from 3 days to 1 week)
- time return to work(through the study completion, an average of 1 year)
- postoperative complications(through the study completion, an average of 1 year)