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Clinical Trials/NCT04912154
NCT04912154
Unknown
N/A

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 site in 1 country200 target enrollmentMay 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Achilles Tendon Rupture
Sponsor
Peking University Third Hospital
Enrollment
200
Locations
1
Primary Endpoint
The time of return to light sports activity
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
June 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The time of return to light sports activity

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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