Restoring Anatomy of Ruptured Achilles Tendon

Not Applicable

Recruiting

• Conditions: Achilles Tendon Rupture

• Registration Number: NCT06723639
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2025-02-28
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Achilles tendon Total rupture score (ATRS)	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 Outcome Measures

Name	Time	Method
Hourly sporting activity	1 year	Data on activity level of sporting activities (h/week), if patients return to the same sport, and if patients return to the same job as prior to the injury will be obtained.
Patient satisfaction	1 year	Patient satisfaction regarding activities of daily living and sport participation will be evaluated using a 5-point Likert scale for satisfaction. With responses ranging from 1 (strongly dissatisfied) to 5 (strongly satisfied).
Tampa Scale of Kinesiophobia	26 weeks & 1 year	Increased fear of movement can be a sequala after an Achilles tendon rupture. The Danish (and swedish in Sweden) version of the Tampa Scale of Kinesiophobia (TSK-11) will be used to assess fear of movement. The TSK-11 is scored on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes negligible or nonexistent kinesiophobia. The highest possible score, 44, denotes a severe fear of experiencing pain while moving.
Heel-rise test	26 weeks & 1 year	Heel-rise muscle function (height) and repetitions will be evaluated using a standardized heel-rise test.
Ultrasonography	1 year	Muscle fascicle length, pennation angle and thickness of the medial gastrocnemius muscle will be measured with B-mode ultrasonography. Power doppler flow in the Achilles tendon will be recorded in the area with the highest visible Power Doppler activity.
Magnetic resonance imaging (MRI)	1 year	A 3D MRI of both Achilles tendons will be obtained. An axial 6-point DIXON sequence will also be applied to assess free fat fraction of the muscles.The uninjured side will serve as an internal control for all measures.
Plantarflexion muscle strength	1 year	Maximal isometric plantar flexion muscle strength will be measured in 10-degree increments from 10 degrees of dorsiflexion to 20 degrees of plantarflexion with the knee in extension (soleus + gastrocnemius) and in flexion (primarily soleus) while seated (Biodex Multi-joint System 4 Pro, Biodex Medical Systems, USA)
Vertical jump performance	1 year	For the countermovement jump, participants are instructed to stand on one leg with their arms folded across their chest, perform a maximal vertical jump, and aim to land in the same spot on the force plate. For the drop jump, participants stand on one leg with their arms folded across their chest on a 20cm box. They then jump down onto the force plate and, upon landing, perform a maximal vertical jump. Each participant will complete three repetitions on each leg for both tasks. For the hopping task, participants stand on one leg with their arms at their sides, as if jumping rope. They performed 25 rhythmic jumps at a self-selected pace, trying to remain in the same spot. Each participant completed two repetitions of the hopping task on each leg
Ankle joint range of motion (ATRA)	26 weeks & 1 year	The passive ankle joint range of motion will be assessed as the Achilles tendon resting angle (ATRA) with the subject lying prone with the knee in full extension (ATRAext) and with the knee in 90 degrees of flexion (ATRAflex) bilaterally using a standard goniometer as previously described. The uninjured side will serve as an internal control.
Knee to wall test	26 weeks & 1 year	Ankle dorsiflexion range of motion will be measured with the knee extended and knee flexed positions of the weight bearing lunge test bilaterally.

Trial Locations

Locations (3)

, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.; 🇩🇰 Copenhagen, Capital, Denmark

Copenhagen University Hospital, Amager-Hvidovre; 🇩🇰 Copenhagen, Capital, Denmark

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden