Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Oswestry Disability index(Arabic version) 1 month
研究概览
简要总结
A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.
详细描述
The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults more than 18 years of age and less than 65 years of age..
- •Degenerative or isthmic spondylolithesis Grade 1,2 and
- •Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
- •Single level pathology involving L2-3, L3-4, L4-5 and or L5-S
- •Symptoms not responding to conservative treatment for at least 3 months.
排除标准
- •Previous spinal fusion or instrumentation.
- •Spinal tumours, infection and fractures.
- •Patients with severe osteoporosis
- •BMI more than
- •Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
- •Patients not willing to participate in the study
研究组 & 干预措施
O-TLIF group
Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.
干预措施: Transforaminal Lumbar Interbody Fusion either open or minimally invasive (Procedure)
MI-TLIF group
Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.
干预措施: Transforaminal Lumbar Interbody Fusion either open or minimally invasive (Procedure)
结局指标
主要结局
Oswestry Disability index(Arabic version) 1 month
时间窗: 1 month
an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
次要结局
- • Fusion rate as assessed by Bridwell fusion score.(1 year)
研究者
Amr Hatem Ahmed Mohammed
Assistant lecturer
Assiut University