NCT01535144已完成不适用
Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Syntellix AG
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- difference of metatarsal angles in degree post surgery and 6 months after surgery
研究概览
简要总结
The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.
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
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients with an age of 40 to 79 years at the day of surgery
- •Symptomatic Hallux Valgus
- •Radiological criterium area of proximal joint angle
- •Normal motorically functions
- •Female patients of childbearing age must be using two reliable contraception methods
排除标准
- •Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
- •BMI > 32
- •Cysts of the first metatarsal of the respective foot
- •Neurological disorders with modified motorically functions
- •Clinical evidence of osteoporosis
- •Chronic renal impairment
- •Known hypersensitivity to components of the implants
- •Regular administration of medications containing the metallic elements of the degradable implant
- •Pregnant or lactating women
- •Current participation in another clinical trial or within 30 days before surgery
结局指标
主要结局
difference of metatarsal angles in degree post surgery and 6 months after surgery
时间窗: up to 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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