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临床试验/NCT05360524
NCT05360524进行中(未招募)不适用

Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability: A Randomized Controlled Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年5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
42
试验地点
2
主要终点
Neurological recovery.

研究概览

简要总结

The aim of study is to compare clinical and radiological outcomes of laminectomy alone to laminectomy and fusion in the treatment of traumatic cervical spinal cord injury without instability.

详细描述

Cervical spinal cord injury (CSCI) without instability tends to be caused by a hyperextension force to the neck. This type of injury has been increasing as the elderly population is dramatically increasing.

Although surgery has become the preferred method for management of traumatic unstable cervical spine injury, the treatment of spinal cord injury (SCI) without instability such as fracture, dislocation, and ligamentous injury, however, remains controversial.

Before deciding for surgical or conservative treatment, one should understand the pathophysiology of SCI. Traumatic SCI is dependent on primary damage, such as the dynamic mechanistic force and static pre-existing or concurrent cord compression, and secondary damage, such as edema, ischemia, and inflammation, which lead to demyelination of axons, apoptosis of neural cells, and glial scar formation in the spinal cord.

Advocates of conservative treatment believe that decompression is not effective here, because the compression may have existed before the injury in asymptomatic patients. Therefore, the symptoms develop after a CSCI without instability are probably not a result of the compression itself. On the other hands advocates of surgical treatment believe that decompression could prevent secondary cord damage due to the vicious cycle of "ischemia-edema-ischemia". However, faced with a patient with neurologic dysfunction MRI evidence of cervical spinal cord compression, decompressive surgery is a practical treatment option.

Since these injuries are stable, why to add fusion to laminectomy when it is possible to perform laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.

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

性别
All
接受健康志愿者

入选标准

  • Patients with traumatic cervical spine cord injury admitted to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery regardless of age, mechanism of injury or neurological status changes.

排除标准

  • Associated cervical spine bony or ligamentous injury.
  • Associated primary focal anterior compression of the cervical spinal cord (clear disc herniation).
  • Associated head injury.
  • Kyphotic cervical spine as measured by C2-C7 Cobb angle on X-ray.
  • Previous surgery of the cervical spine.
  • Patients who refuse to participate in the study
  • Patients who are mentally incompetent or unable to comply with the one year follow up regimen

结局指标

主要结局

Neurological recovery.

时间窗: 3, 6 and 12 month after treatment.

It is assessed by the improvement (changes) in American Spinal Injury Association (ASIA) motor score). it is based on the motor function score of the 10 pairs of key muscles in the upper and lower limbs, with 5 points for each muscle and 100 points in total.

次要结局

  • Neck pain .(3, 6 and 12 month after treatment.)
  • C2-C7 Cobb angle(3, 6 and 12 month after treatment.)
  • C7 slope(3, 6 and 12 month after treatment)
  • C2-C7 sagittal vertical axis(3, 6 and 12 month after treatment)

研究者

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

Mahmoud Sayed Hamed Mohammed

Physician

Assiut University

研究点 (2)

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