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Restoring Anatomy of Ruptured Achilles Tendon

RecruitingNAAges 18 Years - 67 YearsAllBispebjerg Hospital
NCT06723639 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation . We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician. * Presented within 14 days from injury. * Understands and reads Danish. * No contraindications for MRI. Exclusion Criteria: * Smoking * Diabetes * Other injuries affecting their lower limb function. * Contralateral Achilles tendon rupture. * Re-rupture. * Anticoagulation treatment. * Inability to follow rehabilitation or complete follow-up tests. * Immunosuppressive treatment, including systemic corticosteroid treatment. * Pregnant
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What it tests

  • A new two-layer surgical technique
  • Standard non-surgical treatment
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Where

3 sites
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Denmark
Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Denmark
Sahlgrenska University Hospital
Gothenburg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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