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Delayed Loading Following Repair of a Ruptured Achilles Tendon (DELOAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04263493
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Rikke Høffner, Bispebjerg Hospital

Brief Summary:

The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.

The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).


Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Other: Rehabilitation (physiotheraphy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Early mobilization (loading)

This constitutes the currently accepted regime and is therefore considered the control group.

Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3

Other: Rehabilitation (physiotheraphy)
Time of loading, range of motion exercises, strength training

Experimental: Delayed mobilization (loading)
Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3
Other: Rehabilitation (physiotheraphy)
Time of loading, range of motion exercises, strength training




Primary Outcome Measures :
  1. Heel-rise test [ Time Frame: One-year follow-up ]
    Heel-rise height deficit on the injured side relative to the uninjured side


Secondary Outcome Measures :
  1. Tendon length and cross-sectional area [ Time Frame: 1 week, 3 months, 6 months and 1 year ]
    MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.

  2. The Achilles tendon rupture score (ATRS) [ Time Frame: Recall before injury and 1 year ]
    The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.

  3. Muscle fascicle length and doppler activity in the tendon [ Time Frame: 2 weeks, 3 months, 6 months and 1 year ]
    Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography

  4. Isokinetic plantar flexion muscle strength [ Time Frame: 1 year ]
    The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.

  5. Physical activity level [ Time Frame: Recall before injury and 1 year ]
    A questionnaire is used to measure the physical activity level (including type of activity) of the participants.

  6. Heel-rise work [ Time Frame: 6 months and 1 year ]
    An instrumented heel-rise test will be conducted to measure work capacity

  7. The Achilles tendon resting angle (ATRA) [ Time Frame: 2 weeks, 3 months, 6 months and 1 year ]
    Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with a traumatic, complete mid-substance Achilles tendon
  • No contraindications for MRI
  • Presented within 14 days from injury
  • Adult (18 to 60 years)
  • Understand Danish
  • Manage transport to/from the hospital on their own

Exclusion Criteria:

  • Other injuries affecting their lower limb functions
  • Prior Achilles tendon Rupture
  • Smoking
  • Systemic diseases influencing tendon healing
  • Anticoagulation treatment
  • Inability to follow rehabilitation or complete follow-ups
  • Immunosuppressive treatment including systematic corticosteroid treatment

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): NCT04263493


Contacts
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Contact: Rikke Hoeffner, PhD Student +45 38636022 rikke.hoeffner@regionh.dk
Contact: Michael Krogsgaard, Professor +45 38639809 michael.rindom.krogsgaard@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Rikke Høffner, PhD Student    + 45 38636022    rikke.hoeffner@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Peter Magnusson, Professor Institute of Sportsmedicine

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Responsible Party: Rikke Høffner, PhD student, MSc, PT, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04263493    
Other Study ID Numbers: 01012020
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Rikke Høffner, Bispebjerg Hospital:
Achilles Tendon Surgery
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries