NCT01448941已完成不适用
Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AOFAS Midfoot scale
研究概览
简要总结
The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.
详细描述
We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.
We preform arthrodesis of TMT 2 and 3 in both groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and
- •No major fracture in relation to TMT
- •Age 18-65
排除标准
- •Feet with other major foot/ankle injuries
- •Previous foot infection or foot pathology on affected side
- •Previous surgery to the TMT joints
- •Sequelae after previous foot injuries
- •Diabetes mellitus, neuropathy and peripheral vascular disease
结局指标
主要结局
AOFAS Midfoot scale
时间窗: 2 years postoperative
AOFAS Midfoot scale
次要结局
- SF-36(2 years postoperative)
研究者
Are Haukåen Stødle
MD
Oslo University Hospital
研究点 (1)
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