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Delayed Loading Following Repair of a Ruptured Achilles Tendon

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04263493
Acronym
DELOAT
Enrollment
48
Registered
2020-02-10
Start date
2020-05-20
Completion date
2022-10-01
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Surgery

Brief 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).

Interventions

OTHERRehabilitation (physiotheraphy)

Time of loading, range of motion exercises, strength training

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Heel-rise testOne-year follow-upHeel-rise height deficit on the injured side relative to the uninjured side

Secondary

MeasureTime frameDescription
The Achilles tendon rupture score (ATRS)Recall before injury and 1 yearThe Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.
Muscle fascicle length and doppler activity in the tendon2 weeks, 3 months, 6 months and 1 yearMuscle fascicle length and doppler activity in the tendon will be measured with ultrasonography
Isokinetic plantar flexion muscle strength1 yearThe Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.
Tendon length and cross-sectional area1 week, 3 months, 6 months and 1 yearMRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.
Heel-rise work6 months and 1 yearAn instrumented heel-rise test will be conducted to measure work capacity
The Achilles tendon resting angle (ATRA)2 weeks, 3 months, 6 months and 1 yearAchilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.
Physical activity levelRecall before injury and 1 yearA questionnaire is used to measure the physical activity level (including type of activity) of the participants.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026