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Completed

NCT Number: NCT04263493

Delayed Loading Following Repair of a Ruptured Achilles Tendon

The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.

The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with a traumatic, complete mid-substance Achilles tendon
  • No contraindications for MRI
  • Presented within 14 days from injury
  • Adult (18 to 60 years)
  • Understand Danish
  • Manage transport to/from the hospital on their own

Exclusion criteria

  • Other injuries affecting their lower limb functions
  • Prior Achilles tendon Rupture
  • Smoking
  • Systemic diseases influencing tendon healing
  • Anticoagulation treatment
  • Inability to follow rehabilitation or complete follow-ups
  • Immunosuppressive treatment including systematic corticosteroid treatment

Treatment and study plan

Rehabilitation (physiotheraphy)

Other

Time of loading, range of motion exercises, strength training

Primary outcomes

  1. Heel-rise test

    Time frame: One-year follow-up

    Heel-rise height deficit on the injured side relative to the uninjured side

Secondary outcomes

  1. Tendon length and cross-sectional area

    Time frame: 1 week, 3 months, 6 months and 1 year

    MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.

  2. The Achilles tendon rupture score (ATRS)

    Time frame: Recall before injury and 1 year

    The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.

  3. Muscle fascicle length and doppler activity in the tendon

    Time frame: 2 weeks, 3 months, 6 months and 1 year

    Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography

  4. Isokinetic plantar flexion muscle strength

    Time frame: 1 year

    The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.

  5. Physical activity level

    Time frame: Recall before injury and 1 year

    A questionnaire is used to measure the physical activity level (including type of activity) of the participants.

  6. Heel-rise work

    Time frame: 6 months and 1 year

    An instrumented heel-rise test will be conducted to measure work capacity

  7. The Achilles tendon resting angle (ATRA)

    Time frame: 2 weeks, 3 months, 6 months and 1 year

    Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial

Acronym: DELOAT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2020
Registry last updated
Feb 10, 2023

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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