The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663542
• Other study ID #: PekingUTH LY ATR
• Secondary ID: 817021272018YFF0
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2020
• Source: Peking University Third Hospital
• Contact: Yang Lv, M.D.
• Phone: +86-18513112060
• Email: lvyang42[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• immobilization duration
brace immobilization duration after open surgery for Achilles tendon rupture

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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