Actively Recruiting
Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Led by Bispebjerg Hospital · Updated on 2025-04-15
120
Participants Needed
3
Research Sites
N/A
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
This clinical trial investigates a new two-layer surgical technique to restore the anatomy of a ruptured mid-substance Achilles tendon. The study compares this surgical method followed by rehabilitation with a standard non-surgical treatment followed by rehabilitation. The research aims to find out how these approaches affect clinical outcomes, muscle and tendon structure, and function after one year. Participants are randomly assigned to one of two groups: NEWSUR, which receives the new two-layer surgical technique with a detailed rehabilitation program, or CONSER, which receives the standard non-surgical treatment followed by rehabilitation. The surgical technique involves a double row suturing aiming to restore the length of the soleus and gastrocnemius parts of the tendon. During the study, participants will be evaluated on the Achilles tendon Total Rupture Score (ATRS) at one year. Additional assessments include physical activity levels, patient satisfaction, muscle strength, range of motion, imaging tests like MRI and ultrasonography, and functional tests such as heel-rise and vertical jump performance. These evaluations will occur at various time points, mainly at 26 weeks and one year, to monitor recovery and function.
CONDITIONS
Brief 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 by an experienced physician
- Injury occurred within 14 days prior to enrollment
- Understands and reads Danish
- No contraindications for MRI
- Age between 18 and 67 years
You will not qualify if you...
- Smoking
- Diabetes
- Other injuries affecting lower limb function
- Contralateral Achilles tendon rupture
- Re-rupture
- Anticoagulation treatment
- Inability to follow rehabilitation or complete follow-up tests
- Immunosuppressive treatment including systemic corticosteroids
- Pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive either a new two-layer surgical technique followed by a detailed rehabilitation regime or standard non-surgical treatment followed by a detailed rehabilitation regime.
Initial treatment visit followed by multiple rehabilitation visits
Duration - Up to 1 year after treatment
Participants undergo assessments including physical tests, imaging, and patient-reported outcomes to evaluate recovery and tendon function.
Visits at 26 weeks and 1 year
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here