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临床试验/NCT07177651
NCT07177651尚未招募不适用

Comparative Study Between Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis

Assiut University0 个研究点目标入组 2 人开始时间: 2025年10月4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
2
主要终点
Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function)

研究概览

简要总结

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord. Laminectomy with lateral mass fixation is another option of management.

详细描述

Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord.

Laminoplasty is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis, particularly those with accompanying spinal instability or degenerative changes, may not achieve satisfactory outcomes with laminoplasty alone. In such cases, lateral mass fixation is often added to provide supplemental stability to the spine, potentially preventing postoperative deformities and enhancing long-term outcomes

Lateral mass fixation is often combined with posterior decompression and typically done as part of a posterior cervical fusion where screws are placed into the lateral masses (bony structures on the sides of the vertebrae) to stabilize the cervical spine after decompression, such as through a laminectomy. This procedure sacrifices some motion for stability.

A comparative study is needed to better understand the advantages and disadvantages of each approach, in order to guide clinical decision-making and improve patient outcomes.

The general aim is to evaluate and compare the clinical outcomes, safety, and effectiveness of both surgical techniques in managing this condition.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Patients aged 40 ≥ years with clinically significant cervical canal stenosis (based on imaging and neurological symptoms).
  • •Surgical indication for cervical decompression.
  • •Adequate follow up data (minimum 1 year).
  • •Patients fit for surgery.

排除标准

  • •Patients unfit for surgery or contraindication to general anaesthesia.
  • •Congenital deformities or significant spinal deformities unrelated to stenosis.
  • •Patients with cervical kyphosis, active infection or known allergy to titanium.
  • •Previous cervical spine surgery.

研究组 & 干预措施

Laminoplasty

Experimental

干预措施: Laminoplasty (Procedure)

Laminectomy with lateral mass fixation

Experimental

干预措施: Laminectomy with lateral mass fixation (Procedure)

结局指标

主要结局

Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function)

时间窗: Baseline and 6 months postoperatively

Neurological outcome will be assessed using the modified Japanese Orthopaedic Association (mJOA) score, which evaluates motor and sensory function of the upper and lower extremities, as well as bladder function. Scores range from 0-17, with higher scores indicating better neurological function. Assessments will be performed at baseline (pre-operative), and at 6 months postoperatively by a blinded clinician.

次要结局

  • Complication rate within 90 days postoperatively(Within 90 days postoperatively)
  • Length of hospital stay (days)(Perioperative period)

研究者

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

Fahd Abdel Sabour Ahmed Mohammed

Principal investigator, specialist , neurosurgery department

Assiut University

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