The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

Peking University

Status: Unknown

Conditions: Achilles Tendon Rupture

Treatments: Procedure: immobilization duration

Study type: Interventional

Funder types: Other

Identifiers

NCT04663542

PekingUTH LY ATR

81702127 (Other Grant/Funding Number)

2018YFF0301100 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

0-week immobilization

Experimental group

Description:

0-week brace immobilization after the surgery will be conducted.

Treatment:

Procedure: immobilization duration

2-week immobilization

Experimental group

Description:

2-week brace immobilization after the surgery will be conducted.

Treatment:

Procedure: immobilization duration

4-week immobilization

Other group

Description:

4-week brace immobilization after the surgery will be conducted.

Treatment:

Procedure: immobilization duration

6-week immobilization

Other group

Description:

6-week brace immobilization after the surgery will be conducted.

Treatment:

Procedure: immobilization duration