Clinical trial Recruiting at 1 site Interventional Ages 18 to 67

New surgical method for repairing ruptured Achilles tendon

Official title: Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial

Run by Bispebjerg Hospital · NCT06723639 · Data updated 2026-11-12

This study is testing a new two-layer surgery for fixing a ruptured Achilles tendon to see if it helps people recover better than the usual non-surgical treatment.

Quick facts

Study typeInterventional
Ages18 Years to 67 Years
SexAll
Enrollment120 (estimated)
SponsorBispebjerg Hospital
Academic / other
Locations3 sites (Copenhagen, Capital and 2 other locations)
StatusRecruiting
StartedFebruary 28, 2025
Main results expectedJuly 1, 2027
Study endsJuly 1, 2027
Registry record updatedApril 15, 2025
Trial IDNCT06723639 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with a complete mid-substance Achilles tendon rupture within 14 days of injury.

Probably not a fit

Patients with conditions such as diabetes, smoking habits, or other lower limb injuries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a novel two-layer surgical technique aimed at restoring the anatomy of a ruptured Achilles tendon. Participants will be randomly assigned to either the new surgical approach followed by rehabilitation or a standard non-surgical treatment followed by rehabilitation. The study will assess clinical outcomes, muscle and tendon structure, and function one year post-injury. The goal is to determine if the new surgical method leads to better patient-reported outcomes compared to traditional treatment.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with Achilles tendon ruptures.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving surgical outcomes for tendon repairs.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
    Copenhagen, Capital, Denmark
    Recruiting
  • Copenhagen University Hospital, Amager-Hvidovre
    Copenhagen, Capital, Denmark
    Not yet recruiting
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
    Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.