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Achilles Tendon RuptureNCT03525964

Individualized Treatment of Acute Achilles Tendon Rupture

A study testing Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment in people with Achilles Tendon Rupture, run by Central Jutland Regional Hospital at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Achilles Tendon Rupture
What is being tested?
Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
4 sitesDenmark
Study dates
2 Oct 2018to 24 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Appointment in the Outpatients Department within 4 days of injury.
  • Total Achilles tendon rupture.
  • Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
  • The patient must be expected to be able to attend rehabilitation and post-examinations.
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.

Who cannot join

  • Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
  • Previous rupture of the Achilles tendon in any of the two legs.
  • Treated with Fluoroquinolones or corticosteroids within the last 6 months.
  • In medical treatment of diabetes.
  • Suffers from rheumatic disease.
  • Other conditions prior to the injury resulting in reduced function of any of the two legs.
Show all 9Show fewer
  • Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
  • Inability to lie in prone position on the operating table.
  • Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites
  • Copenhagen University Hospital, Hvidovre

    Hvidovre, DK-2650

  • Zealand University Hospital, Køge

    Køge, DK-4600

  • Hospital Lillte Belt, Kolding

    Kolding, DK-6000

  • Jutland Central Regional Hospital

    Viborg, DK-8800

Other trials in Denmark

About this study

Official title: Individualized Treatment for Acute Achilles Tendon Rupture Based on Barfod's Ultrasonographic Length Measure - a Randomized Controlled Trial

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.

The study includes two control groups of non-operative and operative treatment.

Being tested
Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment, Operative treatment
Keywords
Individualized treatment, Functional outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized treatment of Acute Achilles tendon rupture.Procedure or surgery

    The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the Achilles tendon and the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon and consist of the free tendon and the fascia [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. The cut-off at 7% elongation is determined for 75% sensitivity and 65% specificity of elongation.

  • Non-operative treatmentProcedure or surgery

    Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

  • Operative treatmentProcedure or surgery

    Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Study groups in NCT03525964
Study groupRoleWhat they receive
Individualized treatmentExperimentalThe ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast after surgery. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Receives: Procedure: Individualized treatment of Acute Achilles tendon rupture.
Control group 1Active comparatorFor the patients allocated to non-operative treatment the injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Receives: Procedure: Non-operative treatment
Control group 2Active comparatorThe tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.
Receives: Procedure: Operative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heel-rise work test

    An endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel rises are counted and measured and plotted into a diagram on an X-axis and Y-axis respectively. The results are then compared to the weight of the patient and the total work is estimated as area under the curve. The heel lift distance between the heel and the floor is measured in millimeters. The procedure is performed on the uninjured leg first and subsequently on the injured leg. The patient is barefoot for the heel-rise work test and stands on a flat surface with a 10 degree inclination.

    For these functional tests a measurement system MuscleLab (Ergotest Technology, Oslo, Norway) will be used at all the centers.

    Measured: Evaluation method after 12 months of started treatment

Secondary outcomes (5)
  1. Barfod's ultrasonographic length measure

    The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.

    Measured: Evaluation method after 6 and 12 months of started treatment

  2. Indirectly, clinical Achilles tendon length estimate

    Achilles tendon length is indirectly estimated clinically by use of the Achilles Tendon Resting Angle (ATRA) or the Achilles Tendon Length Measure (ATLM). The patient lies flat in prone position on the examination bed. The knee is flexed at 90 degrees and the ankle sits in relaxed position. The ATRA is determined as the angle between the corpus of the fibula and the corpus of the 5th metatarsus. The ATLM is determined as the distance from the caput of the 5th metatarsus to the surface of the examination bed. Both the ATRA and the ATLM are determined for both the injured and the uninjured leg. The difference between the healthy and the injured leg is evaluated

    Measured: Evaluation method after 6 and 12 months of started treatment

  3. Complications

    Incidence rate of the commonly known complications and adverse events such as infection, re-rupture, permanent sural nerve dysfunction, adhesions and pain at the scar is noted. Attention is also paid to so far unknown complications in relation to the treatments.

    Measured: Evaluation method after 12 months of started treatment

  4. Achilles tendon Total Rupture Score (ATRS)

    Patients will fill out the ATRS questionnaire in connection to the follow-up visits in the Outpatients Department. ATRS is a patient-reported outcome measure.

    This questionnaire is a part of the usual examination of the patients' function, and is used during all follow-ups in the usual care.

    Measured: Evaluation method after 6 and 12 months of started treatment

  5. Heel-rise Work test

    An endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel rises are counted and measured and plotted into a diagram on an X-axis and Y-axis respectively. The results are then compared to the weight of the patient and the total work is estimated as area under the curve. The heel lift distance between the heel and the floor is measured in millimeters. The procedure is performed on the uninjured leg first and subsequently on the injured leg. The patient is barefoot for the heel-rise work test and stands on a flat surface with a 10 degree inclination.

    For these functional tests a measurement system MuscleLab (Ergotest Technology, Oslo, Norway) will be used at all the centers.

    Measured: Evaluation method after 6 months of started treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start2 Oct 2018
  3. Primary completion24 Sep 2024
  4. Study completion24 Sep 2024

Resources

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
Model description
Prospective
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525964
Sponsor's protocol ID
Viborg NVK 1-10-72-428-17
Status last verified
Jan 2025
First submitted
20 Mar 2018
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan of sharing data with researchers not already included in this study.

Publications

  • Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.

    PubMed 25038882
  • Toft M, Hansen MS, Vestergaard JD, Jenlar J, Pramming AK, Moller S, Nedergaard BSK, Kristensen MT, Simonsen LL, Viberg B, Holmich P, Barfod KW. Randomised three-armed trial investigation of the Copenhagen Achilles tendon Rupture Treatment Algorithm (CARTA) for individualised treatment of acute Achilles tendon rupture. Br J Sports Med. 2026 Jun 12;60(12):848-855. doi: 10.1136/bjsports-2025-110210.

    PubMed 42082321
  • Hansen MS, Vestermark MT, Holmich P, Kristensen MT, Barfod KW. Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial. Trials. 2020 May 12;21(1):399. doi: 10.1186/s13063-020-04332-z.

    PubMed 32398120

Questions about this trial

What is this clinical trial studying?

A study testing Individualized treatment of Acute Achilles tendon rupture., Non-operative treatment and Operative treatment in people with Achilles Tendon Rupture, run by Central Jutland Regional Hospital at 4 sites in Denmark.

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 6 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: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heel-rise work test (time frame: Evaluation method after 12 months of started treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525964, which also lists 3 linked publications.

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 3 Jan 2025.

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