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Restoring Anatomy of Ruptured Achilles Tendon
Sponsor: Bispebjerg Hospital
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.
Official title: Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 67 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-02-28
Completion Date
2027-07-01
Last Updated
2025-04-15
Healthy Volunteers
No
Conditions
Interventions
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
Locations (3)
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Capital, Denmark
Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Capital, Denmark
Sahlgrenska University Hospital
Gothenburg, Sweden