Postoperative Care After Operatively Treated Ankle Fractures With Cast or Functional Ankle Orthosis. A 2-year, Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Olerud-Molander score
研究概览
简要总结
The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.
The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.
In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weber A or B type ankle fracture
- •uni-, bi- or trimalleolar injury and/or fibular displacement of >2 mm in any plane on the radiographs
排除标准
- •Weber C injury necessitating syndesmotic fixation
- •Pilon injury
- •Inadequate co-operation
- •Other severe concomitant injuries
结局指标
主要结局
Olerud-Molander score
时间窗: 3 months and 24 months
Patient-reported outcome measure, 0-100 points, higher points indicating better result.
次要结局
- Olerud-Molander score(6 weeks and 12 months)
- Kaikkonen score(6 weeks, 3, 12, and 24 months)
- Visual Analog Scale for Pain(6 weeks, 3, 12, and 24 months)
- Swelling of the ankle(6 weeks, 3, 12, and 24 months)
- Atrophy of the calf muscles(6 weeks, 3, 12, and 24 months)
- Ankle active dorsiflexion(6 weeks, 3, 12, and 24 months)
- Ankle active plantarflexion(6 weeks, 3, 12, and 24 months)
- Return-to-work(Within 24 months)
- Subjective symptoms and return to activities(2 and 6 weeks; 3, 12, and 24 months)
研究者
Lasse Rämö
Orthopaedic Surgeon
Helsinki University Central Hospital