Restoring Anatomy of Ruptured Achilles Tendon

Recruiting now · Not applicable

Conditions studied: Achilles Tendon Rupture

In brief

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.

Key facts

Study ID

NCT06723639

Run by

Bispebjerg Hospital

People needed

120

Starts

2025-02-28

Expected to finish

2027-07-01

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older, up to 67. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. — Copenhagen, Capital, Denmark (enrolling)
• Copenhagen University Hospital, Amager-Hvidovre — Copenhagen, Capital, Denmark
• Sahlgrenska University Hospital — Gothenburg, Sweden

Full record on ClinicalTrials.gov

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