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临床试验/NCT06686407
NCT06686407尚未招募不适用

Management of Lumbar Foraminal Stenosis Using Unilateral Biportal Endoscopy Versus Conventional Open Spine Surgery

Assiut University0 个研究点目标入组 32 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
主要终点
Oswestry disability index (ODI)

研究概览

简要总结

The goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. The main questions it aims to answer are:

Does minimally invasive techniques give better results than conventional techniques?

Participants will:

Undergo minimally invasive intervention using unilateral biportal endoscopy for lumbar foraminal stenosis decompression Undergo lumbar fusion for lumbar foraminal stenosis decompression Keep a diary of their symptoms and improvement of these symptoms

详细描述

Lumbar foraminal stenosis decompression will be done using two different techniques:

  1. Conventional Open Lumbar fusion By laminectomy and facetectomy and fixation with screws and rods ± interbody cage
  2. Minimally invasive (Unilateral Biportal Endoscopy) Basic spine surgery instruments, 0° and 30° angled 4-mm diameter endoscopes commonly used in joint arthroscopic surgery, a radiofrequency catheter, Arthroscopic burr, and a shaver.

Surgical approach to the foraminal area Two portals are created to perform this surgery. Water is infused through the endoscope through the viewing portal, and the working portal had an additional purpose as a portal for water outflow. The proximal and distal portals are created 2 cm lateral from the pedicle level on the C-arm anteroposterior image. Each incision for the portals is 0.8 cm in length, which is adequate for instrument and endoscope insertion. For the left side foramen, the proximal and distal portals are used as the viewing and working portals, respectively, and vice versa for the right foramen. After the endoscope insertion through the viewing portal, we secure a space for the lower transverse process around the lateral surface of the facet joint. A radiofrequency catheter or a shaver is used to secure the space, and a radiofrequency catheter is used to control active bleeding.

Decompression of foraminal stenosis After a sufficient working space is obtained, the cranial 50% of the superior articular process of the thickened facet joint is removed using an arthroscopic burr or an osteotome. After removing the superior articular process, the ligamentum flavum around the foramen is removed using a curette and a Kerrison punch. After completion of flavectomy, nerve root and epidural fat are identified. If herniated disc material is found preoperatively, additional discectomy is performed usually from the axilla of the root. Surgery is confirmed to be completed after achieving an amount of free space concordant with the diameter of the nerve root in the foraminal zone, and then a drain tube is inserted.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All Patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic.
  • •Patients (age >18 )

排除标准

  • •Deformity.
  • •Infection of vertebrae.
  • •Tumor of vertebrae.
  • •Instability.

研究组 & 干预措施

Group 1

Experimental

干预措施: Open lumbar decompression ± fusion (Procedure)

Group 2

Experimental

干预措施: Minimally invasive lumbar foraminal decompression using unilateral biportal endoscopy "device" (Procedure)

结局指标

主要结局

Oswestry disability index (ODI)

时间窗: Through study completion, an average of 2 years

Visual analogue scale (VAS)

时间窗: Through study completion, an average of 2 years

次要结局

  • Post operative radiological assessment by MRI on lumbosacral spine.(Through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Eldeen Mohamed Oreaby Adam

Assistant Lecturer

Assiut University

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