NCT06941649尚未招募不适用
Comparison of the Clinical Efficacy of Cervical Single-door Laminoplasty Via the Intermuscular Space Approach and the Conventional Approach: A Multicenter, Prospective Controlled Study
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
- 376
- 主要终点
- modified Japanese Orthopedic Association score
研究概览
简要总结
The goal of this clinical trial is to learn if cervical single-door laminoplasty via the intermuscular space approach can better prevent axial symptom while reaching equal neurological outcome than the conventional approach in adults patients with cervical spondylotic myelopathy. The main questions it aims to answer are:
- Can cervical single-door laminoplasty via the intermuscular space approach better prevent axial symptom than the conventional approach?
- Can cervical single-door laminoplasty via the intermuscular space approach reach the neurological outcome not second to the conventional approach? If there is a comparison group: Researchers will compare the intermuscular space approach and the conventional approach of cervical single-door laminoplasty to see if the intermuscular space approach better prevent axial symptom.
Participants will:
- Received cervical single-door laminoplasty via the intermuscular space approach or the conventional approach once meet the indication.
- Visit the clinic 1 month, 3 months, 6 months, 1 year and 2 years after the surgery.
- Keep a diary of their symptoms and other unexpected conditions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cervical spondylotic myelopathy meeting surgery indications.
- •Sign informed consent
排除标准
- •Poor general condition, can not tolerate surgery
- •Patients with long course of disease, degenerative spinal cord, atrophy of limb muscles, and severe joint dysfunction
- •The cervical spine has obvious segmental instability, especially in the case of injury or lesion of the anterior structure, which has not been healed
- •History of cervical spine surgery
- •Combined with obvious cervical kyphosis
- •Combined with cervical fracture, dislocation, etc
- •Combined with cervical spinal infection, arthritis and other pathological changes
- •Combined with tumors of cervical spine or spinal cord.
- •Mental retardation or other causes of limited behavioral ability
研究组 & 干预措施
Via the intermuscular space
Experimental
干预措施: Expansive open-door laminoplasty via intermuscular space approach (Procedure)
Control
Sham Comparator
干预措施: cervical single-door laminoplasty via the conventional approach (Procedure)
结局指标
主要结局
modified Japanese Orthopedic Association score
时间窗: 2 years after operation
Evaluate neurological function in 4 dimension with a total of 18 points: A. Upper limb motor dysfunction(5 points) B. Lower limb motor dysfunction(7 points) C. Sensory dysfunction(3 points) D. Sphincter dysfunction(3 points)
次要结局
- modified Japanese Orthopedic Association Score(Before surgery and 1week, 1month, 3months, 6months, 1year after surgery)
- Cervical Visual Analogue Scale Score(Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery)
- Zeng's axial symptom scale(Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery)
- Hosono axial symptom scale(Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery)
- Cervical 11-point Numerical Rating Scale(Before surgery; 1week, 1month, 3months, 6months, 1year and 2 years after surgery)
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