Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

赞助:

合作者:

信息的提供 (责任方):

Amr Hatem Ahmed Mohammed，Assiut University

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

November 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Oswestry Disability index(Arabic version) 1 month[ Time Frame: 1 month ]

an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

• Fusion rate as assessed by Bridwell fusion score.[ Time Frame: 1 year ]
Grade I is defined as fusion with remodelling and trabeculae present; Grade II is an intact graft with incomplete remodelling and no lucency present; Grade III is an intact graft with potential lucency at the cranial or caudal end; Grade IV is absent fusion with collapse/resorption of the graft.

描述性信息

简略标题 ^ICMJE

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

正式标题 ^ICMJE

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

简要概况

A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.

详细说明

The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive
Spinal fusion procedure through the intervertebral foramen

研究工具

Other: O-TLIF group
Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.
Other: MI-TLIF group
Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2021

预计主要完成日期

November 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Adults more than 18 years of age and less than 65 years of age.. - Degenerative or isthmic spondylolithesis Grade 1,2 and 3. - 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-S1. - Symptoms not responding to conservative treatment for at least 3 months. Exclusion Criteria: - Previous spinal fusion or instrumentation. - Spinal tumours, infection and fractures. - Patients with severe osteoporosis - BMI more than 35. - Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome) - Patients not willing to participate in the study

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Amr Hatem Ahmed Mohammed，Assiut University

研究赞助商 ^ICMJE

Assiut University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Assiut University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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