Restoring Anatomy of Ruptured Achilles Tendon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A new two-layer surgical technique, Standard non-surgical treatment.
- Who it may be relevant to
- Registry conditions: Achilles Tendon Rupture. Basic parameters: 18 years — 67 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Overview
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.
Interventions
- Procedure 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. - Other Standard non-surgical treatment
Standard non-surgical treatment
Primary outcome measures
- The Achilles tendon Total rupture score (ATRS) [Time frame: At 1 year]
Secondary outcome measures (10)
- Hourly sporting activity [Time frame: 1 year]
- Patient satisfaction [Time frame: 1 year]
- Tampa Scale of Kinesiophobia [Time frame: 26 weeks & 1 year]
- Heel-rise test [Time frame: 26 weeks & 1 year]
- Ultrasonography [Time frame: 1 year]
- Magnetic resonance imaging (MRI) [Time frame: 1 year]
- Plantarflexion muscle strength [Time frame: 1 year]
- Vertical jump performance [Time frame: 1 year]
- Ankle joint range of motion (ATRA) [Time frame: 26 weeks & 1 year]
- Knee to wall test [Time frame: 26 weeks & 1 year]
Eligibility criteria
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
- Smoking
- Diabetes
- 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.
- Pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. — Copenhagen
- Copenhagen University Hospital, Amager-Hvidovre — Copenhagen
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT06723639 · H-24041516