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Completed

NCT Number: NCT04956614

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immobilisation duration

Device

immobilisation duration of 2,4,6 week after suture of Achilles tendon

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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