NL-OMON41376已完成4 期
Interbody fusion devices in the treatment of cervicobrachial syndrome; a blinded randomised trial of cancellous structured ceramic (CSC) versus PEEK cages. - CASCADE Trial
Amedica Corporation0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age between 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.
- •* Written informed consent .
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.
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