CompletedNot Applicable

Individualized Treatment of Acute Achilles Tendon Rupture

Denmark300 participantsStarted 2018-10-02

Plain-language summary

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon. The study includes two control groups of non-operative and operative treatment.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Appointment in the Outpatients Department within 4 days of injury. * Total Achilles tendon rupture. * Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury. * The patient must be expected to be able to attend rehabilitation and post-examinations. * The patient must be able to speak and understand Danish. * The patient must be able to give informed consent. Exclusion Criteria: * Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae. * Previous rupture of the Achilles tendon in any of the two legs. * Treated with Fluoroquinolones or corticosteroids within the last 6 months. * In medical treatment of diabetes. * Suffers from rheumatic disease. * Other conditions prior to the injury resulting in reduced function of any of the two legs. * Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg. * Inability to lie in prone position on the operating table. * Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heel-rise work test

Timeframe: Evaluation method after 12 months of started treatment

Trial details

NCT IDNCT03525964

SponsorCentral Jutland Regional Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-24

View on ClinicalTrials.gov More Achilles Tendon Rupture trials