Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Neck Disability Index
研究概览
简要总结
This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 75 years
- •Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
- •At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
- •Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
- •Ability and willingness to comply with project requirements
- •Written informed consent given by the subject or the subject's legally authorised representative
排除标准
- •Previous cervical surgery (either anterior or posterior)
- •Increased motion on dynamic studies (> 3 mm)
- •Severe segmental kyphosis of the involved disc level (> 7 degrees)
- •Patient cannot be imaged with MRI
- •Neck pain only (without radicular or medullary symptoms)
- •Infection
- •Metabolic and bone diseases (osteoporosis, severe osteopenia)
- •Neoplasma or trauma of the cervical spine
- •Spinal anomaly (Klippel Feil, Bechterew, OPLL)
- •Severe mental or psychiatric disorder
- •Inadequate Dutch language
- •Planned (e)migration abroad in the year after inclusion
结局指标
主要结局
Neck Disability Index
时间窗: 24 months post-op
The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.
次要结局
- Fusion Status(3 mo., 6mo., 12 mo., 24 months)