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临床试验/NCT04912154
NCT04912154Unknown不适用

A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
The time of return to light sports activity

研究概览

简要总结

This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to study the difference in efficacy between the groups.

详细描述

This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • acute closed single-legged complete Achilles tendon rupture .
  • age of 18 to 60 years.

排除标准

  • patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
  • an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) .
  • those without rehabilitation or follow-up outcomes.

结局指标

主要结局

The time of return to light sports activity

时间窗: From operation to 1-year follow-up after the surgery

When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.

次要结局

  • Range of motion (ROM) recovery time(from operation to 1-year follow-up after the surgery)
  • Recovery time of the single-legged heel rise height (SHRH)(From operation to 1-year follow-up after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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