Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
研究概览
简要总结
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
详细描述
The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
时间窗: baseline, 6 month post-operative visit
The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered). The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.
次要结局
- Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale(2 year postoperative visit)
研究者
Glenn G. Shi, M.D.
Orthopedic Consultant
Mayo Clinic