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The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

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ClinicalTrials.gov Identifier: NCT04912154
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to study the difference in efficacy between the groups.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Procedure: Rehabilitation protocol Not Applicable

Detailed Description:
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Traditional rehabilitation protocol
Traditional rehabilitation protocol after the surgery will be conducted
Procedure: Rehabilitation protocol
Rehabilitation protocol after open surgery for Achilles tendon rupture

Active Comparator: Accelerated rehabilitation protocol
Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted
Procedure: Rehabilitation protocol
Rehabilitation protocol after open surgery for Achilles tendon rupture




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.



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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.

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): NCT04912154


Contacts
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Contact: Yang Lv, M.D. +8682267010 lvyang42@126.com
Contact: Yuan Cao, M.M. +8682267010 cy6415@126.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Contact: Yang Lv, M.D.    +8601082267010    lvyang42@126.com   
Contact: Yuan Cao, M.M.    +8601082267010    cy6415@126.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Jie Qiao, M.D. Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04912154    
Other Study ID Numbers: PekingUTH LYCY ATR
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
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:
traditional rehabilitation protocol
accelerated rehabilitation protocol
ultrasonic monitoring
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries