Restoring Anatomy of Ruptured Achilles Tendon

Condition(s) studied

Investigational drug(s) / intervention(s)

A new two-layer surgical technique: 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: Standard non-surgical treatment

Study 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

Primary outcome measure(s)

• The Achilles tendon Total rupture score (ATRS) — At 1 year
  The Achilles tendon Total rupture score (ATRS) will be used. The ATRS is a patient-reported instrument with high reliability, validity, and sensitivity for measuring the outcome related to symptoms and physical activity after treatment in patients with a total Achilles tendon rupture. The scale is from 0-100. A score of 100 points indicates full function and no pain with lower scores indicating reduced function.

Trial sites (3)

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