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CompletedNCT04263493DELOATUpdated Feb 10, 2023

Delayed Loading Following Repair of a Ruptured Achilles Tendon

An interventional study of Rehabilitation (physiotheraphy) in Achilles Tendon Rupture, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

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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Conditions studied

  • Achilles Tendon Rupture

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Keywords

  • Achilles Tendon Surgery
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 48 is below the median of 72 across 334 interventional studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Early mobilization (loading)

    This constitutes the currently accepted regime and is therefore considered the control group. Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3

    Other: Rehabilitation (physiotheraphy)

  • Experimental
    Delayed mobilization (loading)

    Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3

    Other: Rehabilitation (physiotheraphy)

Interventions

  • OtherRehabilitation (physiotheraphy)

    Time of loading, range of motion exercises, strength training

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What researchers measure

Primary outcomes

  1. Heel-rise test

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

    Time frame: One-year follow-up

Secondary outcomes

  1. Tendon length and cross-sectional area

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

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

  2. The Achilles tendon rupture score (ATRS)

    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.

    Time frame: Recall before injury and 1 year

  3. Muscle fascicle length and doppler activity in the tendon

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

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

  4. Isokinetic plantar flexion muscle strength

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

    Time frame: 1 year

  5. Physical activity level

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

    Time frame: Recall before injury and 1 year

  6. Heel-rise work

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

    Time frame: 6 months and 1 year

  7. The Achilles tendon resting angle (ATRA)

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

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

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Study locations

1 site
  • Bispebjerg Hospital
    Copenhagen, 2400, Denmark
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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04263493
Lead sponsor
Bispebjerg Hospital
Responsible party
Rikke Høffner (PhD student, MSc, PT, Bispebjerg Hospital) — Principal investigator
First posted
Feb 10, 2020
Start date
May 20, 2020
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Last update
Feb 10, 2023

Study contacts

Peter Magnusson, Professor
principal investigator · Institute of Sportsmedicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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