Delayed Loading Following Repair of a Ruptured Achilles Tendon

Study Overview
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Brief Summary
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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).

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

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Other: Rehabilitation (physiotheraphy)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early mobilization (loading)<br>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)<br>* Time of loading, range of motion exercises, strength training<br>|
| Experimental: Delayed mobilization (loading)<br>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)<br>* Time of loading, range of motion exercises, strength training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel-rise test | Heel-rise height deficit on the injured side relative to the uninjured side | One-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 1 year | 
| Physical activity level | A questionnaire is used to measure the physical activity level (including type of activity) of the participants. | Recall before injury and 1 year | 
| Heel-rise work | An instrumented heel-rise test will be conducted to measure work capacity | 6 months and 1 year | 
| 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. | 2 weeks, 3 months, 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles Tendon Surgery