Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle): A Pilot Randomized Controlled Single-Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
This pilot randomized controlled trial will evaluate the safety and feasibility of beginning weight-bearing earlier after surgery for an unstable trimalleolar ankle fracture.
Trimalleolar ankle fractures involve three parts of the ankle and usually require surgery to restore and stabilize the joint. After surgery, patients are commonly instructed not to place weight on the injured ankle for approximately six weeks. However, earlier weight-bearing may improve mobility and recovery without increasing complications. Additional evidence is needed specifically for patients with trimalleolar fractures.
Participants will be randomly assigned in a 1:1 ratio to one of two postoperative rehabilitation groups. The early weight-bearing group will begin placing weight on the injured ankle two weeks after surgery. The delayed weight-bearing group will begin weight-bearing six weeks after surgery, which reflects the current standard approach. Both groups will begin ankle range-of-motion exercises approximately two weeks after surgery.
Participants will be followed for 52 weeks. Ankle function, mobility, quality of life, complications, and routine X-ray findings will be assessed during follow-up. The study will also evaluate participant recruitment, adherence to the assigned rehabilitation protocol, and completeness of study data.
The results will help determine whether a larger randomized controlled trial should be conducted and may contribute to future rehabilitation recommendations for patients recovering from surgically treated trimalleolar ankle fractures.
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)
盲法说明
Participants and intervention providers cannot be blinded because of the nature of the assigned weight-bearing instructions. Outcome assessments will be conducted by personnel blinded to treatment allocation to the best of the study team's ability.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Operative fixation of an unstable trimalleolar ankle fracture, with or without a syndesmotic injury requiring fixation.
- •Satisfactory anatomical reduction and rigid internal fixation achieved according to established AO principles, including fixation of the posterior malleolus where indicated.
- •Surgery performed within 14 days of the injury.
- •Able and willing to provide informed consent.
排除标准
- •Lack of protective sensation, such as peripheral neuropathy.
- •Unable to adhere to trial procedures.
- •Bilateral operatively treated ankle fractures.
- •Treatment of the index fracture with a hindfoot nail.
- •Morbid obesity, defined as body mass index greater than
- •Diabetes.
- •Neuroarthropathy.
研究组 & 干预措施
Early Weight-Bearing
Participants will remain non-weight-bearing for the first 2 weeks after surgery. Beginning 2 weeks postoperatively, participants will start weight-bearing as tolerated on the affected leg, using walking aids as needed. Participants will also begin standardized active and passive ankle range-of-motion exercises at 2 weeks after surgery.
干预措施: Postoperative Weight-Bearing Rehabilitation Protocol (Other)
Delayed Weight-Bearing
Participants will remain non-weight-bearing on the operated leg for 6 weeks after surgery, using walking aids as needed. After 6 weeks, participants may begin weight-bearing as tolerated. Participants will begin the same standardized active and passive ankle range-of-motion exercises at 2 weeks after surgery.
干预措施: Postoperative Weight-Bearing Rehabilitation Protocol (Other)
结局指标
主要结局
Participant Recruitment Rate
时间窗: Throughout the 12-month recruitment period
Feasibility of recruitment will be assessed using the number and proportion of screened patients who meet the eligibility criteria and the proportion of eligible patients who consent to participate. The protocol identifies an eligibility-rate target of at least 60% and a consent-rate target of at least 30%.
Percentage of Participants Adherent to the Assigned Weight-Bearing Protocol
时间窗: From randomization through 6 weeks after surgery
Participant adherence will be assessed using self-reported compliance with the assigned early or delayed weight-bearing protocol. Measures will include intervention compliance and crossover between treatment groups. The protocol specifies an intervention-compliance target of at least 90% and a crossover-rate target of no more than 5%.
Completeness of Primary Outcome Data
时间窗: Through 52 weeks after surgery
Feasibility of data collection will be assessed using the proportion of participants with complete and valid Olerud and Molander Ankle Score data and the proportion lost to follow-up. The protocol specifies a valid primary-outcome-data target of at least 80% and an attrition or loss-to-follow-up target of no more than 15%.
Olerud and Molander Ankle Score at 3 Months
时间窗: 12 weeks after surgery
Ankle function will be measured using the Olerud and Molander Ankle Score (OMAS). The OMAS ranges from 0 to 100 points, with higher scores indicating better ankle function and fewer symptoms. Scores will be compared between the Early Weight-Bearing and Delayed Weight-Bearing groups. The score assesses ankle symptoms and the ability to perform activities such as walking, running, jumping, and stair use. The protocol specifies a non-inferiority margin of -8 points.
次要结局
- Change in Olerud and Molander Ankle Score(6, 12, 26, and 52 weeks after surgery)
- Foot and Ankle Ability Measure Score(6, 12, 26, and 52 weeks after surgery)
- EuroQol 5-Dimension 5-Level Score(6, 12, 26, and 52 weeks after surgery)
- Visual Analog Scale Score(6, 12, 26, and 52 weeks after surgery)
- Incidence of Postoperative Complications(From randomization through 52 weeks after surgery)
- Incidence of Radiological Loss of Reduction(2, 6, 12, 26, and 52 weeks after surgery)