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The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

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ClinicalTrials.gov Identifier: NCT04663542
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Procedure: immobilization duration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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
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
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


Outcome Measures
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Primary Outcome Measures :
  1. the time of return to light sports activity [ Time Frame: 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 :
  1. range of motion (ROM) recovery time [ Time Frame: 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.

  2. recovery time of the single-legged heel rise height (SHRH) [ Time Frame: 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.


Other Outcome Measures:
  1. visual analogue scale (VAS) [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
    VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.

  2. American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
    The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.

  3. the Achilles tendon Total Rupture Score (ATRS) [ Time Frame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663542


Contacts
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Contact: Yang Lv, M.D. +86-18513112060 lvyang42@126.com
Contact: Xiangyu Xu, M.D. +86-15210849431 307542744@qq.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Yang Lv, M.D.    +8610-82267010    zhouf@bjmu.edu.cn   
Contact: Xiangyu Xu, M.D.    +86-15210849431    307542744@qq.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Jie Qiao, M.D. Peking University Third Hospital
More Information
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04663542    
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 )
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
immobilization duration
open surgery
early rehabilitation
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries