Functional Outcomes After Conservative Management of the Acutely Ruptured Achilles Tendon in the Under 60 Age Group. A Randomised Controlled Trial Comparing Standard Conservative Management With Accelerated Rehabilitation Using a Moon Boot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- SMFA (Short Musculoskeletal Function Assessment Questionnaire)
研究概览
简要总结
The purpose of this study is to directly compare traditional plaster treatment with early weightbearing in a walking boot for the non operative treatment of acute achilles tendon rupture.
详细描述
This injury has traditionally been treated in a plaster cast applied to the leg for a period of 10 weeks which allows the tendon to heal, or by an operation to repair the tendon. Research undertaken in the investigators department has shown that patients treated with surgery or with a plaster had similar chance of re-rupture of the tendon after treatment and gain a similar recovery. The investigators therefore now manage these injuries in a plaster.
More recently, further research has shown that a new type of non-surgical rehabilitation programme, which is quicker than the traditional non-surgical programme, gave a tendon re-rupture rate that was similar to that after surgical treatment. This new rehabilitation programme uses a walking boot fitted with a heel-raise (instead of the traditional plaster). The potential benefit of this quicker rehabilitation programme is that it allows the patient to put weight through the leg immediately, whereas patients treated with the traditional plaster cast non-surgical treatment cannot weight bear (this means that they are kept non-weightbearing and therefore have to use crutches) for the first 8 weeks. The time spent in the walking boot in this new, quicker rehabilitation programme is 8 weeks while that spent in plaster is 10 weeks. This new non-surgical, quicker rehabilitation programme is referred to as the accelerated non-surgical programme hereafter. There are no known increased risks with the accelerated rehabilitation programme.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16-60 years old with an acute rupture of the Achilles tendon
排除标准
- •Patients who do not have an acute rupture (ie. delayed presentation >2 weeks)
- •Patients who present with a re-rupture of a previously treated Achilles tendon
- •Patients from outside the Lothian (local treatment) area who are unwilling to attend follow-up at the study institution.
- •Latex allergy.
结局指标
主要结局
SMFA (Short Musculoskeletal Function Assessment Questionnaire)
时间窗: final followup/one year
46 question score. Patients are asked to tick boxes labelled between 1 (indicating good function/no problems) and 5 (poor function/significant problems) for each question and the responses are used to calculate a "dysfunction index", a "bother index" and an "overall SMFA score". These will be reported for each group with measure of central tendency (mean/median) and standard deviations/interquartile range.
次要结局
- Ankle and subtalar motion(10, 26 and 52 weeks)
- SMFA (Short Musculoskeletal Function Assessment Questionnaire)(Post-injury (completed at initial review))
- Incidence of thromboembolic events(1 year)
- Foot and Ankle Outcomes Questionnaire(Post-injury (completed at initial review))
- Achilles Tendon Total Rupture Score (ATRS)(Post-injury (completed at initial review))
- Return to work.(10,26,52 weeks.)
- EQ-5D Index and EQ-5D VAS(Pre-injury and post-injury (completed at initial review), 26 weeks and 52 weeks)
- Patient Preference question(16 weeks)
- Calf circumference(10, 26 and 52 weeks)
- Visual Analogue Score (VAS) for pain(Initial review, 4,8,10,26,52 weeks.)
- Achilles tendon rerupture rate(1 year)
- Return to driving or public transport.(10,26,52 weeks.)
- Return to sport.(10,26,52 weeks.)
- Satisfaction Question(10, 16, 26 and 52 weeks)