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Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

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ClinicalTrials.gov Identifier: NCT04956614
Recruitment Status : Completed
First Posted : July 9, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
This study is a prospective randomized controlled clinical study. After the novel Achilles tendon rupture repaired , patients were randomly divided into 4 groups according to immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the same suture technique with a similar rehabilitation protocol and were examined clinically at 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the groups.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Device: immobilisation duration Not Applicable

Detailed Description:

This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilisation duration by dividing the patients into four groups according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture technique. The primary outcome was the time of return to light sports activity (LSA). Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH). Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS) were also collected. Demographic baseline data were analysed using one-way analysis of variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05.

The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

The excluded criteria were patients with prior ATR and those without rehabilitation or follow-up outcomes. Other situations that affected patients' lower limb functions or tendon healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were also excluded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2021

Arm Intervention/treatment
Experimental: suture of Achilles tendon without immobilisation Device: immobilisation duration
immobilisation duration of 2,4,6 week after suture of Achilles tendon

Experimental: suture of Achilles tendon with immobilisation Device: immobilisation duration
immobilisation duration of 2,4,6 week after suture of Achilles tendon




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.

    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:

patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

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): NCT04956614


Locations
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China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04956614    
Other Study ID Numbers: LM2020252
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 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:
Duration of immobilisation
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries