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临床试验/NCT04420832
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

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

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katarina Nilsson Helander

Principal investigator

Sahlgrenska University Hospital

研究点 (2)

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