NCT04663542

The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, 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 immobilization times by dividing the patients into four groups-A, B, C, and D-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. 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 and undergo a similar rehabilitation protocol after the brace is removed.

Conditions

• Achilles Tendon Rupture

Interventions

Type	Name	Description
PROCEDURE	immobilization duration	brace immobilization duration after open surgery for Achilles tendon rupture

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2020-12-11
• Last updated: 2020-12-11

Locations

1 site across 1 country: China