Delayed Loading Following Repair of a Ruptured Achilles Tendon

Bispebjerg Hospital48 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Achilles Tendon Rupture

Interventions

Rehabilitation (physiotheraphy)OTHER

Time of loading, range of motion exercises, strength training

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Heel-rise test

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

Time frame: One-year follow-up

Secondary Outcomes

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

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

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

Isokinetic plantar flexion muscle strength

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

Time frame: 1 year

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

Heel-rise work

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

Time frame: 6 months and 1 year

Data from ClinicalTrials.gov

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