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临床试验/NCT06045663
NCT06045663进行中(未招募)不适用

Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
assessment of cervical spine sagittal alignment

研究概览

简要总结

The cervical spine consists of seven cervical vertebrae joined by intervertebral disks and a complex network of ligaments. The cervical spine has a normal lordotic curve, and it is much more mobile than the thoracic or lumbar regions of the spine, which makes it more liable to both degenerative and traumatic disorders .

Degenerative cervical myelopathy (DCM) is the most common form of spinal cord dysfunction in adults. The incidence and prevalence of myelopathy due to degeneration of the spine are estimated at a minimum of 41 and 605 per million in North America and Incidence of cervical spondylotic myelopathy-related hospitalizations has been estimated at 4.04/100,000 person-years.

Degenerative cervical myelopathy (DCM), earlier referred to as cervical spondylotic myelopathy, Patients report neurological symptoms such as pain and numbness in limbs, poor coordination, imbalance, and bladder dysfunction.

Surgical management for patients with multilevel cervical myelopathy aims to decompress the spinal cord and restore the normal sagittal alignment using either an anterior approach or a posterior approach. Multilevel anterior surgery is associated with complications such as increased surgical trauma and increased incidence of pseudarthrosis, graft dislodgement, and implant failure as the number of level increases.The posterior approach is optimal for multilevel stenosis using consecutive laminectomies However, although the effectiveness of cervical laminectomy was documented repeatedly, there were still concerns over postoperative kyphotic deformity, cervical instability, and late deterioration Cervical laminectomy and fusion may be performed to avoid the potential complications of instability and kyphosis associated with cervical laminectomy alone. For the latter, dissection and removal of the posterior elements disrupts the normal biomechanics of the cervical spine, leading to post laminectomy deformity and instability Our study aim to evaluate the multilevel cervical laminectomy alone, and multilevel cervical laminectomy with lateral mass fixation in patients with cervical spondylotic myelopathy regarding the Clinical and radiological outcome for short term follow-up.

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
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signs and symptoms of spondylotic myelopathy at two or more level cervical canal stenosis after full filling clinical and radiological criteria

排除标准

  • History of previous cervical intervention like (anterior cervical approach and laminoplasty ).
  • History of cervical trauma.
  • History of other neurological disorders such as( Multiple sclerosis , stroke,AML,....ETC).
  • patient with insuffient data.
  • Uncontrolled DM, hypertension and thyroid disorders.
  • Osterpenic or osteoporotic patients

结局指标

主要结局

assessment of cervical spine sagittal alignment

时间窗: 6 months

assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle

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

Moustafa ElBadry Alrabyi Ahmed

Resident of neurosurgery department, Sohag University Hospitals

Sohag University

研究点 (1)

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