Early Weight Bearing for Isolated Fibular Fractures: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Participant Pain after surgery
研究概览
简要总结
It is common practice to restrict weight bearing after ankle fracture open reduction and internal fixation (ORIF) until week 6 postoperatively. However, controversy exists surrounding the optimal postoperative protocol. At our institution, all ankle fractures are made non-weight bearing for 6 weeks across the board. Isolated lateral malleolar fractures after ORIF may benefit from earlier weight bearing in terms of patient satisfaction, short-term functionality, and return to work. The purpose of this study is to determine if early weight bearing at 2 weeks postoperatively for isolated lateral malleolar fractures leads to a higher satisfaction with surgery as compared to standard protocol for postoperative ankle fractures and better functional outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult patients (age>18) undergoing surgical treatment for isolated lateral malleolar fracture with foot and ankle surgeons at the Rothman Orthopaedic Institute
排除标准
- •Patients requiring other fracture fixation, deltoid ligament repair, or syndesmosis fixation
- •Revision ankle fracture cases
- •Pre-existing impaired mobility,
- •Pre-existing cognitive disability,
- •Open fractures,
- •BMI >40,
- •Diabetes mellitus (DM)
结局指标
主要结局
Participant Pain after surgery
时间窗: 24 weeks
Participant Pain will be measured using the Visual Analog Scale for Pain (VAS) score
Participant Satisfaction with treatment #1
时间窗: 24 weeks
Participant satisfaction will be measured using the Short Form-12 survey (SF-12)
Participant Satisfaction with treatment #2
时间窗: 24 weeks
Participant satisfaction will be measured using the Foot and Ankle Ability Measure (FAAM) scores
次要结局
未报告次要终点