Clinical trial NCT06723639: Restoring Anatomy of Ruptured Achilles Tendon
Official title: Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture
MRI
Surgery
Restore anatomy
Heel-rise test
Rehabilitation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Hvidovre
name: Sahlgrenska University Hospital
First posted: 2024-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Achilles tendon Total rupture score (ATRS)
timeFrame: At 1 year
Secondary outcomes:
measure: Hourly sporting activity
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Tampa Scale of Kinesiophobia
timeFrame: 26 weeks & 1 year
measure: Heel-rise test
timeFrame: 26 weeks & 1 year
measure: Ultrasonography
timeFrame: 1 year
measure: Magnetic resonance imaging (MRI)
timeFrame: 1 year
measure: Plantarflexion muscle strength
timeFrame: 1 year
measure: Vertical jump performance
timeFrame: 1 year
measure: Ankle joint range of motion (ATRA)
timeFrame: 26 weeks & 1 year
measure: Knee to wall test
timeFrame: 26 weeks & 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
state: Capital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Amager-Hvidovre
state: Capital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: