A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 12
- 主要终点
- Fusion Assesment
研究概览
简要总结
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
详细描述
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. Device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better understanding of outcomes associated with it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria.
- •Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
- •Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
- •Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
- •At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).
排除标准
- •History of cervical spine surgery less than 12 months prior to surgery.
- •Diagnosis of severe spondylosis.
- •Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
- •Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)
结局指标
主要结局
Fusion Assesment
时间窗: 12 months
The primary outcomes of interest for this study will be fusion assessment at 3 months, 6 months and 12 months post-surgery. Fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria: Bridging bone inside or outside of graft No lucencies at the graft-vertebral body junction Motion \< 1mm
次要结局
- Subsidence(12 months)