Restoring Anatomy of Ruptured Achilles Tendon (RATAR)

Bispebjerg Hospital

Status: Enrolling

Conditions: Achilles Tendon Rupture

Treatments: Procedure: A new two-layer surgical technique; Other: Standard non-surgical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06723639

H-24041516

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NEWSUR

Experimental group

Description:

Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.

Treatment:

Procedure: A new two-layer surgical technique

CONSER

Other group

Description:

Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.

Treatment:

Other: Standard non-surgical treatment