Restoring Anatomy of Ruptured Achilles Tendon (RATAR)

Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Procedure: A new two-layer surgical technique; Other: Standard non-surgical treatment

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital
    • Copenhagen, Capital, Denmark, 2400
      • Recruiting
      • , Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
      • Contact: Rikke Høffner; Phone Number: +45 38635675; Email: rikke.hoeffner@regionh.dk
      • Contact: Rikke Høffner
    • Copenhagen, Capital, Denmark
      • Not yet recruiting
      • Copenhagen University Hospital, Amager-Hvidovre
• Sweden
  • Gothenburg, Sweden
    • Not yet recruiting
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEWSUR; Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.	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 Names: Operation; Repair; Sutur
Other: CONSER; Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.	Other: Standard non-surgical treatment; Standard non-surgical treatment; Other Names: Conservative; Standard; No surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Achilles tendon Total rupture score (ATRS)	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.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hourly sporting activity	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.	1 year
Heel-rise test	Heel-rise muscle function (height) and repetitions will be evaluated using a standardized heel-rise test.	26 weeks & 1 year
Ultrasonography	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.	1 year
Magnetic resonance imaging (MRI)	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.	1 year
Plantarflexion muscle strength	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)	1 year
Vertical jump performance	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	1 year
Ankle joint range of motion (ATRA)	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.	26 weeks & 1 year
Knee to wall test	Ankle dorsiflexion range of motion will be measured with the knee extended and knee flexed positions of the weight bearing lunge test bilaterally.	26 weeks & 1 year
Patient satisfaction	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).	1 year
Tampa Scale of Kinesiophobia	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.	26 weeks & 1 year

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Copenhagen University Hospital, Hvidovre; Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Rehabilitation; Surgery; Achilles tendon rupture; Restore anatomy; Heel-rise test
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: H-24041516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No