NCT02727595Unknown不适用
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- IMA Reduction
研究概览
简要总结
The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight less than 100 kilos
- •IMA greater than 12 degrees
- •IMA less than 7 degrees
排除标准
- •Diabetics
- •Known osteoporosis
- •Known allergy or hypersensitivity to metals
- •Gout or any systemic inflammatory arthropathy
结局指标
主要结局
IMA Reduction
时间窗: One year
The IMA angle is measured pre-op and post-op on x-ray images using internal software. The IMA at end of study should be less than 10 degrees or a reduction of more than 5 degrees.
次要结局
- American Orthopedic Foot and Ankle Society (AOFAS) Score(One year)
研究者
研究点 (2)
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