NCT01770639已完成不适用
A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
AO Clinical Investigation and Publishing Documentation3 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Treatment failure within the first year after surgery
研究概览
简要总结
The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Age ≥ 18 at date of inclusion
- •Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications:
- •Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
排除标准
- •Prisoner at date of inclusion
结局指标
主要结局
Treatment failure within the first year after surgery
时间窗: Date of surgery to 1 year posto-op
The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery.
次要结局
- Immobilization and non-weightbearing(Date of surgery to time of full weightbearing)
- Surgery details(Date of surgery)
- Adverse events related to the treatment or device under investigation(Date of surgery to 2 years post-op)
- Treatment failure within the first two years after surgery(Date of surgery to 2 years post-op)
- Foot angles(Pre-op, post-op, 6w, 12w, 6m, 12m)
研究者
研究点 (3)
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