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临床试验/CTRI/2026/04/107688
CTRI/2026/04/107688尚未招募不适用

A Randomized Controlled Trial Comparing Cervical Laminectomy with and without Intraoperative Neuromonitoring in Degenerative Cervical Myelopathy

Ganga Orthopaedics Research and Education Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Degenerative cervical myelopathy (DCM) is a common cause of spinal cord dysfunction requiring surgical decompression in patients with progressive neurological deficits. Posterior cervical laminectomy is widely used for multilevel disease and can be performed using either en bloc or piecemeal techniques. While en bloc laminectomy provides rapid decompression, it may result in sudden spinal cord expansion and intraoperative neuromonitoring changes. In contrast, piecemeal laminectomy allows gradual decompression and may reduce intraoperative neural stress.

There is limited prospective randomized evidence comparing these two techniques. This study is a single-center randomized controlled trial designed to compare intraoperative neuromonitoring responses (MEPs and SEPs), perioperative parameters, and clinical outcomes between en bloc and piecemeal laminectomy in patients with cervical spondylotic myelopathy.

A total of 100 patients will be enrolled and randomized into two groups. The primary outcome is intraoperative neuromonitoring changes, while secondary outcomes include neurological recovery (mJOA score), complications, operative time, and blood loss. The findings of this study aim to provide evidence to guide surgical decision-making and improve patient outcomes in cervical myelopathy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult patients more than 18 years of age, Clinical diagnosis of cervical myelopathy, Multilevel involvement.
  • more than 2 levels requiring posterior decompression, Neuutral or lordotic cervical spine, Ability to provide written informed consent.

排除标准

  • cervical kyphosis -Conditions requiring anterior and posterior surgery -Previous cervical spine surgery.
  • Trauma, infection, tumor, or inflammatory spinal disease.

研究者

发起方
Ganga Orthopaedics Research and Education Foundation
申办方类型
Other [Registered Trust, Darpan registration no-TN/2018/0191674]
责任方
Principal Investigator
主要研究者

Prof S.Rajasekaran

Ganga Medical Centre and Hospital

研究点 (1)

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