An Open-label Randomized Multi-centre Study to Evaluate Anterior Controllable Antedisplacement and Fusion Versus Posterior Laminoplasty in Patients With Cervical Ossification of the Posterior Longitudinal Ligament
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 167
- 试验地点
- 13
- 主要终点
- C-JOA Recovery Rate
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.
详细描述
This is a national, multicenter, prospective, randomized controlled trial to compare the safety and efficacy of ACAF and posterior laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament. In this study, 164 adult patients aged 18-70 with severe copll were randomly assigned to the experimental group (using ACAF) and the control group (using lamp) according to the ratio of 1:1. The patients were followed up for 2 years.
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
盲法说明
In view of the obvious differences between the two surgery methods, this study was designed as an open-label trial. However, the results of X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) will be independently reviewed by an independent radiographic review committee in a blind fashion in addition to the evaluation by site investigators.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's age is 18-70 years old, regardless of gender;
- •The patient was diagnosed as severe ossification of the posterior longitudinal ligament (X-ray or CT showed ossification of the posterior longitudinal ligament); The imaging findings showed occupied ratio ≥ 60% or involved three or more segments;
- •Symptoms of spinal cord and nerve root compression, or accompanied by spinal cord compression symptoms such as dysfunction of urination and defecation, conservative treatment was ineffective or aggravated gradually;
- •The participant (or his legal guardian) can sign the informed consent.
排除标准
- •Congenital malformations (including but not limited to occipitocervical malformations, congenital cervical fusion, cervical related neurovascular malformations), ossification of cervical ligamentum flavum, cervical trauma, cervical cancer, cervical tuberculosis and other inflammatory diseases;
- •Patients with other spinal diseases such as thoracolumbar vertebrae that affect clinical symptoms; Patients with motor neuron diseases such as amyotrophic lateral sclerosis and other nervous system diseases;
- •The symptoms were aggravated due to recent trauma;
- •Patients who participated in other clinical trials in recent 3 months;
- •The participant (or his legal guardian) with mental illness and cognitive impairment can not give full informed consent;
- •Those who are in poor health and can not tolerate surgery; The patients were not suitable for surgical treatment after preoperative examination.
研究组 & 干预措施
ACAF
Participants underwent anterior decompression of Anterior Controllable Antedisplacement and Fusion
干预措施: ACAF (Procedure)
Laminoplasty
Participants underwent posterior decompression of Laminoplasty
干预措施: Laminoplasty (Procedure)
结局指标
主要结局
C-JOA Recovery Rate
时间窗: Time point of outcome: 24 months post-operative follow-up visits
(postoperative JOA score at 24 months follow-up - preoperative JOA score)/(17 - preoperative JOA score)\* 100%
次要结局
- Neck Disability Index(28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits)
- Japanese Orthopaedic Association Scores(28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits)
- Visual Analogue Scale(28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits)
- Nurick-Score(28 days before operation and 3, 6, 12, 24 months post-operative follow-up visits)