Restoring Anatomy of Ruptured Achilles Tendon
Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Bispebjerg Hospital
120 participants
Feb 28, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria9
- 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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Interventions
A new double row suturing technique attempting to restore the length of the distinct soleus and gastrocnemius portions of the Achilles tendon.
Standard non-surgical treatment
Locations(3)
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NCT06723639