NCT04420832进行中(未招募)不适用
Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
Sahlgrenska University Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Difference in functional outcome between patients treated surgically and non-surgically
研究概览
简要总结
Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute achilles tendon rupture diagnosed less than 48 hours from injury
- •mid-substance rupture
排除标准
- •previous achilles tendon rupture
- •lower leg disability
- •diabetes mellitus
- •neurovascular disease
- •immunosuppression
- •non-Swedish speaker
结局指标
主要结局
Difference in functional outcome between patients treated surgically and non-surgically
时间窗: 24 months
The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance
次要结局
- Achilles Tendon Rupture Score (ATRS)(24 months)
- Physical Activity Scale (PAS)(24 months)
- Ultrasonography (US)(24 months)
研究者
Katarina Nilsson Helander
Principal investigator
Sahlgrenska University Hospital
研究点 (2)
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