Delayed Loading Following Repair of a Ruptured Achilles Tendon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-10-01

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).

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Detailed Description

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Conditions

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Achilles Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Rehabilitation (physiotheraphy)

Intervention Type OTHER

Time of loading, range of motion exercises, strength training

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

Group Type EXPERIMENTAL

Rehabilitation (physiotheraphy)

Intervention Type OTHER

Time of loading, range of motion exercises, strength training

Interventions

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Rehabilitation (physiotheraphy)

Time of loading, range of motion exercises, strength training

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No