Achilles Tendon RuptureRATARNCT06723639
Restoring Anatomy of Ruptured Achilles Tendon
A study testing A new two-layer surgical technique and Standard non-surgical treatment in people with Achilles Tendon Rupture, run by Bispebjerg Hospital at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- A new two-layer surgical technique and Standard non-surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Feb 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Smoking
- Diabetes
- Other injuries affecting their lower limb function.
- Contralateral Achilles tendon rupture.
- Re-rupture.
- Anticoagulation treatment.
Show all 9Show fewer
- Inability to follow rehabilitation or complete follow-up tests.
- Immunosuppressive treatment, including systemic corticosteroid treatment.
- Pregnant
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Denmark2 sites, 2 recruiting
- Recruiting
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Capital, 2400
Rikke Høffner, +45 38635675, rikke.hoeffner@regionh.dk
Rikke Høffner
- Not yet recruiting
Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Capital
Sweden1 site, 1 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg
About this study
Official title: 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- A new two-layer surgical technique, Standard non-surgical treatment
- Keywords
- Achilles tendon rupture, MRI, Surgery, Restore anatomy, Heel-rise test, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new two-layer surgical techniqueProcedure or surgery
Also called Repair, Sutur, Operation
A new double row suturing technique attempting to restore the length of the distinct soleus and gastrocnemius portions of the Achilles tendon.
Standard non-surgical treatmentOther
Also called Standard, Conservative, No surgery
Standard non-surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| NEWSUR | Experimental | Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime. Receives: Procedure: A new two-layer surgical technique |
| CONSER | Other | Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime. Receives: Other: Standard non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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.
Measured: 26 weeks & 1 year
Heel-rise test
Heel-rise muscle function (height) and repetitions will be evaluated using a standardized heel-rise test.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 26 weeks & 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start28 Feb 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Rikke Høffner, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723639
- Sponsor's protocol ID
- H-24041516
- Acronym
- RATAR
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06723639
- Acronym / sponsor ID
- RATAR / H-24041516
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, MRI, Surgery, Restore anatomy, Heel-rise test, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Sahlgrenska University Hospital
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEWSUR | Experimental | Procedure: A new two-layer surgical techniqueParticipants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime. |
| CONSER | Other | Other: Standard non-surgical treatmentParticipants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Smoking
- Diabetes
- Other injuries affecting their lower limb function.
- Contralateral Achilles tendon rupture.
- Re-rupture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A new two-layer surgical techniqueAlso: Repair, Sutur, OperationA new double row suturing technique attempting to restore the length of the distinct soleus and gastrocnemius portions of the Achilles tendon. | Procedure or surgery | NEWSUR |
| Standard non-surgical treatmentAlso: Standard, Conservative, No surgeryStandard non-surgical treatment | Other | CONSER |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Denmark
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A new two-layer surgical technique and Standard non-surgical treatment in people with Achilles Tendon Rupture, run by Bispebjerg Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Achilles tendon Total rupture score (ATRS) (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.