Non-operative Treatment of Acute Achilles Tendon Rupture, Early Controlled Mobilization Compared With Immobilization: A Blinded Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Achilles tendon Total Rupture Score
研究概览
简要总结
Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture.
Type of study
Randomized, controlled trial (RCT). 130 patients will be included.
Time schedule
Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years
Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed.
Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups:
- The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3.
- The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.
Treatment protocol for the two groups is similar concerning orthose, removal of wedges and weight-bearing. The only difference is that patients in the intervention group are instructed to do ankle exercise.
Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12 months. The study's primary endpoint is at the 12 month mark.
Population Patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint).
Number of patients 65 patients will be included in each group (a 130 patients in total).
详细描述
Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture.
Study Design Type of study The study is performed as a single-blinded, randomized, controlled trial (RCT). The randomisation is computer based; opaque envelopes are used. In total 130 patients will be included.
Time schedule Recruitment of patients for the study begins 1st of November 2013. The expected study period is 4-5 years; the recruitment itself is expected to span 2 years, provided that an average of 6 patients is included per month.
Method Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed.
Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rupture happened within 5 days.
- •Age 18-70 years.
- •The patient must be expected to be able to attend rehabilitation and post-examinations.
- •The patient must be able to speak and understand Danish.
- •The patient must be able to give informed consent.
排除标准
- •Former rupture of one or both Achilles tendon(s).
- •Previous surgery on the Achilles tendon.
- •Fluoroquinolone treatment within the last 6 months.
- •Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
- •The patient has been diagnosed with arterial insufficiency in the legs.
- •Terminal illness or severe medical illness: ASA score higher than or equal to
- •The space between the rupture and the calcaneus is less than 1cm.
研究组 & 干预措施
Controlled early mobilization
The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 to 8
干预措施: Controlled early mobilization (Procedure)
Immobilization
The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.
结局指标
主要结局
Achilles tendon Total Rupture Score
时间窗: 12 months
A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.
次要结局
- Achilles tendon Total Rupture Score(24 months)
- Return to work(24 months)
- Return to sports(24 months)
- Single heel-rise test(12 months)
- Heel-rise work test(12 months)
- Perimeter of calf(12 months)
- Ultrasound length measure(12 months)
- Achilles Tendon Length Measure (ATLM)(12 months)
- Plantarflexion power(12 months)
- Cost effectiveness analysis(12 months)
- Re-rupture(24 months)
- Achilles Tendon Resting Angle (ATRA)(12 months)
研究者
Kristoffer Barfod
MD
Hvidovre University Hospital