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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

Tracking Information
First Submitted Date  ICMJE May 31, 2021
First Posted Date  ICMJE June 3, 2021
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2021)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery
Official Title  ICMJE A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Achilles Tendon Rupture
Intervention  ICMJE Procedure: Rehabilitation protocol
Rehabilitation protocol after open surgery for Achilles tendon rupture
Study Arms  ICMJE
  • Experimental: Traditional rehabilitation protocol
    Traditional rehabilitation protocol after the surgery will be conducted
    Intervention: Procedure: Rehabilitation protocol
  • Active Comparator: Accelerated rehabilitation protocol
    Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted
    Intervention: Procedure: Rehabilitation protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yang Lv, M.D. +8682267010 lvyang42@126.com
Contact: Yuan Cao, M.M. +8682267010 cy6415@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04912154
Other Study ID Numbers  ICMJE PekingUTH LYCY ATR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jie Qiao, M.D. Peking University Third Hospital
PRS Account Peking University Third Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP