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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 67
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
RECRUITING
Copenhagen
Copenhagen University Hospital, Amager-Hvidovre
NOT_YET_RECRUITING
Copenhagen
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 120
Treatments
Experimental: NEWSUR
Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.
Other: CONSER
Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.
Related Therapeutic Areas
Sponsors
Leads: Bispebjerg Hospital
Collaborators: Sahlgrenska University Hospital, Copenhagen University Hospital, Hvidovre

This content was sourced from clinicaltrials.gov