NCT06723639

Restoring Anatomy of Ruptured Achilles Tendon

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achilles Tendon Rupture

Interventions

Type	Name	Description
PROCEDURE	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.
OTHER	Standard non-surgical treatment	Standard non-surgical treatment

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-12-09
• Last updated: 2025-04-15

Locations

3 sites across 2 countries: Denmark, Sweden