The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

Not Applicable

• Conditions: Achilles Tendon Rupture
• Interventions: Procedure: immobilization duration

• Registration Number: NCT04663542
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-12-06
• Last Update Submitted: 2020-12-06
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0-week immobilization	immobilization duration	0-week brace immobilization after the surgery will be conducted.
4-week immobilization	immobilization duration	4-week brace immobilization after the surgery will be conducted.
6-week immobilization	immobilization duration	6-week brace immobilization after the surgery will be conducted.
2-week immobilization	immobilization duration	2-week brace immobilization after the surgery will be conducted.

Primary Outcome Measures

Name	Time	Method
the time of return to light sports activity	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 Outcome Measures

Name	Time	Method
recovery time of the single-legged heel rise height (SHRH)	from operation to 1-year follow-up after the surgery	The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.
range of motion (ROM) recovery time	from operation to 1-year follow-up after the surgery	the recovery time will be recorded when the ROM is similar to that of the uninjured side.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China