A Randomized Controlled Trial Comparing Cervical Laminectomy with and without Intraoperative Neuromonitoring in Degenerative Cervical Myelopathy
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. Posterior cervical laminectomy is a widely used procedure for multilevel disease. Intraoperative neuromonitoring (IONM) is often used to assess spinal cord function during surgery; however, its routine use remains variable, and its clinical benefit is not clearly established.
This prospective randomized controlled trial aims to compare postoperative neurological outcomes between patients undergoing cervical laminectomy with and without intraoperative neuromonitoring. A total of 100 patients will be enrolled and randomized into two groups. Outcomes assessed include postoperative neurological status, intraoperative neuromonitoring changes, functional recovery using mJOA score, complications, and perioperative parameters. The study aims to evaluate the clinical utility of intraoperative neuromonitoring in improving surgical outcomes in patients with degenerative 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 (morethan 18 years) Clinical diagnosis of degenerative cervical myelopathy Radiological evidence of cervical spinal cord compression on MRI Multilevel cervical stenosis (morethan 2 levels) requiring posterior decompression Preserved or neutral cervical sagittal alignment Planned for posterior cervical laminectomy Ability to provide written informed consent.
排除标准
- •Cervical kyphotic deformity requiring alternative surgical approach Indication for combined anterior and posterior surgery Prior cervical spine surgery Non-degenerative pathology (trauma, infection, tumor, inflammatory disease) Severe medical comorbidities precluding surgery Patients unwilling or unable to provide informed consent.
研究者
S Rajasekaran
Ganga Medical Centre and Hospital