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

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.

Study Overview

• Status: Unknown
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Procedure: immobilization duration

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangyu Xu, M.D.; Phone Number: +86-15210849431; Email: 307542744@qq.com
• Study Contact Backup: Name: Yang Lv, M.D.; Phone Number: +86-18513112060; Email: lvyang42@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Xiangyu Xu, M.D.; Phone Number: +86-15210849431; Email: 307542744@qq.com
      • Contact: Yang Lv, M.D.; Phone Number: +8610-82267010; Email: zhouf@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0-week immobilization; 0-week brace immobilization after the surgery will be conducted.	Procedure: immobilization duration; brace immobilization duration after open surgery for Achilles tendon rupture
Experimental: 2-week immobilization; 2-week brace immobilization after the surgery will be conducted.	Procedure: immobilization duration; brace immobilization duration after open surgery for Achilles tendon rupture
Other: 4-week immobilization; 4-week brace immobilization after the surgery will be conducted.	Procedure: immobilization duration; brace immobilization duration after open surgery for Achilles tendon rupture
Other: 6-week immobilization; 6-week brace immobilization after the surgery will be conducted.	Procedure: immobilization duration; brace immobilization duration after open surgery for Achilles tendon rupture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time of return to light sports activity	when the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.	from operation to 1-year follow-up after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion (ROM) recovery time	the recovery time will be recorded when the ROM is similar to that of the uninjured side.	from operation to 1-year follow-up after the surgery
recovery time of the single-legged heel rise height (SHRH)	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.	from operation to 1-year follow-up after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score	The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
the Achilles tendon Total Rupture Score (ATRS)	The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
visual analogue scale (VAS)	VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: open surgery; early rehabilitation; immobilization duration
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: PekingUTH LY ATR; 81702127 (Other Grant/Funding Number: National Natural Science Foundation of China); 2018YFF0301100 (Other Grant/Funding Number: Science and Technology fund of Winter Olympics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No