Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- The Achilles tendon Total rupture score (ATRS)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Other injuries affecting their lower limb function.
- •Contralateral Achilles tendon rupture.
- •Re-rupture.
- •Anticoagulation treatment.
- •Inability to follow rehabilitation or complete follow-up tests.
- •Immunosuppressive treatment, including systemic corticosteroid treatment.
Arms & Interventions
NEWSUR
Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.
Intervention: A new two-layer surgical technique (Procedure)
CONSER
Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.
Intervention: Standard non-surgical treatment (Other)
Outcomes
Primary Outcomes
The Achilles tendon Total rupture score (ATRS)
Time Frame: At 1 year
The Achilles tendon Total rupture score (ATRS) will be used. The ATRS is a patient-reported instrument with high reliability, validity, and sensitivity for measuring the outcome related to symptoms and physical activity after treatment in patients with a total Achilles tendon rupture. The scale is from 0-100. A score of 100 points indicates full function and no pain with lower scores indicating reduced function.
Secondary Outcomes
- Hourly sporting activity(1 year)
- Patient satisfaction(1 year)
- Tampa Scale of Kinesiophobia(26 weeks & 1 year)
- Heel-rise test(26 weeks & 1 year)
- Ultrasonography(1 year)
- Magnetic resonance imaging (MRI)(1 year)
- Plantarflexion muscle strength(1 year)
- Vertical jump performance(1 year)
- Ankle joint range of motion (ATRA)(26 weeks & 1 year)
- Knee to wall test(26 weeks & 1 year)
Investigators
Rikke Høffner
Post doc, PhD, PT
Bispebjerg Hospital