Actively Recruiting
Restoring Anatomy of Ruptured Achilles Tendon
Led by Bispebjerg Hospital · Updated on 2025-04-15
120
Participants Needed
3
Research Sites
121 weeks
Total Duration
On this page
Sponsors
B
Bispebjerg Hospital
Lead Sponsor
C
Copenhagen University Hospital, Hvidovre
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Restoring Anatomy of Ruptured Achilles Tendon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician
- Injury occurred within 14 days prior to enrollment
- Understands and reads Danish
- No contraindications for MRI
- Aged between 18 and 67 years
You will not qualify if you...
- Smoking
- Diabetes
- Other injuries affecting lower limb function
- Previous rupture of the opposite Achilles tendon
- Re-rupture of the Achilles tendon
- Currently on anticoagulation treatment
- Unable to follow rehabilitation or complete follow-up tests
- Receiving immunosuppressive treatment, including systemic corticosteroids
- Pregnant
AI-Screening
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Trial Site Locations
Total: 3 locations
1
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Capital, Denmark, 2400
Actively Recruiting
2
Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Capital, Denmark
Not Yet Recruiting
3
Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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