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Individualized Treatment of Acute Achilles Tendon Rupture

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ClinicalTrials.gov Identifier: NCT03525964
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
The Danish Rheumatism Association
Information provided by (Responsible Party):
Marianne Toft Vestermark, Central Jutland Regional Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Procedure: Individualized treatment of Acute Achilles tendon rupture. Procedure: Non-operative treatment Procedure: Operative treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective
Masking: Single (Outcomes Assessor)
Masking Description: The posterior site of the achilles tendon region is covered by dark tape during the functional assesments.
Primary Purpose: Treatment
Official Title: Individualized Treatment for Acute Achilles Tendon Rupture Based on Barfod's Ultrasonographic Length Measure - a Randomized Controlled Trial
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : May 14, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Individualized treatment

The 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.

Procedure: Individualized treatment of Acute Achilles tendon rupture.
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.

Active Comparator: Control group 1

For 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.

Procedure: Non-operative treatment
Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Active Comparator: Control group 2

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 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.

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




Primary Outcome Measures :
  1. Heel-rise work test [ Time Frame: Evaluation method after 12 months of started treatment ]

    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.



Secondary Outcome Measures :
  1. Barfod's ultrasonographic length measure [ Time Frame: Evaluation method after 6 and 12 months of started treatment ]
    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.

  2. Indirectly, clinical Achilles tendon length estimate [ Time Frame: Evaluation method after 6 and 12 months of started treatment ]
    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

  3. Complications [ Time Frame: Evaluation method after 12 months of started treatment ]
    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.

  4. Achilles tendon Total Rupture Score (ATRS) [ Time Frame: Evaluation method after 6 and 12 months of started treatment ]

    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.


  5. Heel-rise Work test [ Time Frame: Evaluation method after 6 months of started treatment ]

    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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525964


Contacts
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Contact: Marianne T Vestermark, MD PhD +4578446692 marianne.vesterarmk@viborg.rm.dk
Contact: Edvard P Hvidt, MD +4578446563 peter.hvidt@viborg.rm.dk

Locations
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Denmark
Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Denmark, DK-2650
Contact: Kristoffer W Barfod, MD PhD    +4540134773    kbarfod@dadlnet.dk   
Contact: Maria S Hansen, MSc       maria.swennergren.hansen@regionh.dk   
Hospital Lillte Belt, Kolding Recruiting
Kolding, Denmark, DK-6000
Contact: Claus W Henriksen, MD    +4576 36 22 74    claus.w.henriksen@rsyd.dk   
Contact: Stefan Møller, PT    +4576 36 22 74    stefan.moller@rsyd.dk   
Zealand University Hospital, Køge Not yet recruiting
Køge, Denmark, DK-4600
Contact: Anna K Pramming, MD    +4528117292    ankpr@regionsjaelland.dk   
Contact: Louise L Simonsen, MD    +4560630666    llsm@regionsjaelland.dk   
Jutland Central Regional Hospital Recruiting
Viborg, Denmark, DK-8800
Contact: Marianne T Vestermark, MD PhD    +4578446692    marianne.vestermark@viborg.rm.dk   
Contact: Edvard P Hvidt, MD    +4578446563    peter.hvidt@viborg.rm.dk   
Sponsors and Collaborators
Central Jutland Regional Hospital
The Danish Rheumatism Association
Investigators
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Principal Investigator: Marianne T Vestermark, MD PhD Central Jutland Regional Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marianne Toft Vestermark, Head of Orthopaedic Resaerch, MD PhD, Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT03525964    
Other Study ID Numbers: Viborg NVK 1-10-72-428-17
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan of sharing data with researchers not already included in this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marianne Toft Vestermark, Central Jutland Regional Hospital:
Individualized treatment
Functional outcome
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries