Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 192
- 试验地点
- 8
- 主要终点
- The Olerud-Molander ankle function score
研究概览
简要总结
Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.
详细描述
This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers.
The primary outcome measure is the Olerud-Molander scores assess on 12 months after operation of an unstable ankle fracture. The Olerud-Molander scores were compared between the experimental group (early weightbearing) and the control group (non-weightbearing) on 12 month follow-up examination.
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
The secondary objectives are to determine whether early weightbearing is superior to non-weightbearing with respect to time until return to normal daily life and time to full weightbearing.
Other objectives are to determine safety by assessing number of participants with adverse effect such as hardware failure, reduction loss, non-union, or delayed union in each group.
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
- None
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
- •unstable ankle fracture requiring open reduction and internal fixation
- •age between 18 and 65 years
- •satisfactory reduction and stable fixation after operation.
排除标准
- •open fractures
- •comminuted fractures
- •pathologic fractures
- •Pilon fractures
- •Trimalleolar fractures
- •fracture dislocations
- •Fractures requiring syndesmotic screw fixation
- •Fractures with cartilage injuries or unstable fixation or any other conditions preventing from early weightbearing.
- •Patients with diabetes or neuroarthropathy
- •Patients with obesity (BMI >30, weight >100 kg)
- •Any other conditions that are expected to prevent the patients from following the study protocol
结局指标
主要结局
The Olerud-Molander ankle function score
时间窗: 12 months post-operative
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
次要结局
- Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS)(upto 12 months)
研究者
Hyong Nyun Kim
professor, MD, PhD
Hallym University Medical Center