Ultrasonographic Guided Treatment of Acute Achilles Tendon Rupture. Evaluation of Two Novel Ultrasonographic Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS
研究概览
简要总结
With this project the investigators wish to:
- Test the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
- Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
- Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.
详细描述
Study objectives
To validate Amlang's ultrasound classification and investigate whether the treatment of acute Achilles tendon ruptures (ATR) can be guided by:
- Amlang's ultrasound classification of ATR
- Barfod's ultrasound measurement to determine the elongation of the Achilles tendon following a rupture Backgrund A larger group of patients end up with a poor outcome after treatment for ATR. ATR is a frequent and potentially debilitating injury that typically affects young active adults (11 to 37 per 100,000)1 2 3. Consequently, there are great socioeconomic benefits in optimizing treatment and shortening time of recovery.
There is currently no consensus regarding the best treatment of ATR. Traditionally the operative treatment has been considered superior, however recent studies show that non-operative treatment is a safe treatment which leads to good results 4 5 6. For this reason a transition towards greater use of non-operative treatment is seen in many orthopedic departments 7.
Patients who end up with a poor result after treatment for ATR typically suffer from rerupture of the tendon or an elongation of the tendon. There is a 5-10 percent risk of rerupture 4 5 6. It is unknown how many patients heal with an elongation of the Achilles tendon. Correct length of the Achilles tendon is essential for the subsequent function of the tendon.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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.
结局指标
主要结局
Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS
时间窗: 1 year
We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to ATRS (the Achilles tendon Total Rupture Score).
次要结局
- Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test(1 year)
研究者
Kristoffer Barfod
MD, PhD
Hvidovre University Hospital