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临床试验/NCT07542054
NCT07542054尚未招募不适用

Segmental Decompression Versus Wide Decompression With Fixation in Treatment of Degenerative Lumbar Canal Stenosis

Assiut University0 个研究点目标入组 56 人开始时间: 2026年5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
56
主要终点
Functional Recovery as Assessed by the Oswestry Disability Index (ODI)

研究概览

简要总结

The purpose of this study is to compare two different surgical techniques for treating degenerative lumbar canal stenosis, a condition where the lower spinal canal narrows and puts pressure on the spinal nerves. For patients who continue to experience significant back and leg pain after at least three months of non-surgical treatments, surgery is often recommended to relieve the pressure.

Currently, there is an ongoing debate among spine surgeons regarding the most effective surgical approach. This study will evaluate and compare the outcomes of two established methods:

  1. Segmental Decompression Alone: A procedure focused purely on removing the bone and tissue that is pressing on the spinal nerves.
  2. Wide Decompression with Fixation: A more extensive removal of compressive structures, combined with adding spinal hardware (pedicle screws and rods) to stabilize the spine.

Researchers will observe 56 patients over an 18-month period. The primary goal is to determine if one technique offers better functional recovery and pain relief than the other. Researchers will measure success by tracking changes in patients' daily physical function (using the Oswestry Disability Index), reductions in lower back and leg pain, improvements in walking distance, and the time it takes to perform the surgery.

Eligible participants are adult males and females over the age of 40 with symptomatic multilevel stenosis, provided their dynamic x-rays do not show existing spinal instability.

详细描述

Lumbar spinal canal stenosis secondary to degenerative disease is a common condition associated with the aging process that may ultimately lead to the compression of neural elements within the lumbar canal. The degenerative process is often a response to hypermobility and can contribute to spinal instability. While conservative treatment is generally regarded as the first-line approach, surgical decompression is indicated for symptom alleviation in patients whose symptoms persist despite adequate nonoperative management. The primary objective of surgery for lumbar stenosis is the relief of neurogenic claudication, followed by an improvement in walking capacity and a reduction of leg pain.

Over the past two decades, spinal surgeons have become increasingly familiar with instrumentation techniques, leading to a marked rise in the use of pedicle screws and rods for the treatment of degenerative lumbar stenosis. However, attention has recently shifted toward reassessing the routine use of these fusion procedures. A sustained debate continues among experts regarding the optimal surgical management, aiming to better define the indications for fusion and avoid its unnecessary application. This study aims to provide emerging evidence to help establish clearer conclusions by evaluating whether segmental decompression alone or wide decompression with fixation offers superior clinical and radiological advantages for selected patient groups.

The trial will be conducted across the Neurosurgery departments of Assiut University Hospitals and Misr University Teaching Hospital. Patient data will be collected using standardized, coded case report forms to ensure confidentiality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 40 years
  • Both males and females
  • Multilevel lumbar canal stenosis with failed routine conservative treatment at least 3 months
  • X-ray dynamic views of the lumbar spine showing no evidence of instability

排除标准

  • Age less than 40 years
  • Recurrent cases and screw revision cases
  • Degenerative scoliosis

研究组 & 干预措施

Segmental Decompression Alone

Active Comparator

Participants in this arm will undergo surgical segmental decompression without spinal fixation for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.

干预措施: Segmental Decompression (Procedure)

Wide Decompression with Fixation

Active Comparator

Participants in this arm will undergo wide surgical decompression combined with spinal fixation utilizing pedicle screws and rods for the treatment of symptomatic multilevel degenerative lumbar canal stenosis.

干预措施: Wide Decompression with Fixation (Procedure)

结局指标

主要结局

Functional Recovery as Assessed by the Oswestry Disability Index (ODI)

时间窗: Baseline, 3 months, 6 months, and 12 months postoperative

Functional disability will be quantified using the Oswestry Disability Index (ODI) questionnaire. The ODI is a validated index scored from 0 to 100, where 0 indicates no disability and 100 indicates maximum possible disability. A decrease in the score from baseline indicates functional improvement and a better surgical outcome.

次要结局

未报告次要终点

研究者

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

Abdelrahman Ebrahim Hussein Shehata

Resident at Neurosurgery Department, Misr University for Science and Technology

Assiut University

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