Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Clinical outcome (NDI)
研究概览
简要总结
Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
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
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
- •virgin spines
- •no emergency operation
- •age above 18
- •sufficient knowledge of the German language
- •indication for anterior cervical discectomy and fusion
- •absence of concomitant spinal disease
排除标准
- •prior cervical surgery
- •indications other than ACDF
- •concomitant neoplastic, metabolic, severe general or infectious disease
结局指标
主要结局
Clinical outcome (NDI)
时间窗: 12 months postoperative
NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).
次要结局
- Clinical outcome (VAS-neck), Subsidence(12 months postoperative)
研究者
Martin Barth, MD
M. D., Vice-chairman
Universitätsmedizin Mannheim