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Early Mobilization After Achilles Tendon Rupture (EarlyM-Achil)

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ClinicalTrials.gov Identifier: NCT02318472
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : September 21, 2021
Sponsor:
Collaborator:
OPED GmbH
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Brief Summary:
The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Deep Venous Thrombosis Device: VACOped orthosis Device: Plaster cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Direct Functional Mobilization After Achilles Tendon Rupture on Healing and Outcome
Actual Study Start Date : November 2013
Actual Primary Completion Date : March 2019
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early mobilization
Functional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle
Device: VACOped orthosis
Weight-bearing orthosis with adjustable range of motion of the ankle

Active Comparator: Immobilization
Treatment as usual using plaster cast immobilization
Device: Plaster cast
Lower limb plaster cast




Primary Outcome Measures :
  1. Deep venous thrombosis (DVT) [ Time Frame: Six weeks ]
    At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)


Secondary Outcome Measures :
  1. Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: Four years ]
    The functional outcome will be assessed at 26 and 52 weeks and 3-4 years postoperatively by validated muscular endurance test, i.e. heel rise test.

  2. Patient-reported outcome - ATRS [ Time Frame: Four years ]
    The patients' symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS). 6, 12 months and 3-4 years postoperatively

  3. Patient-reported outcome - EQ-5D [ Time Frame: One year ]
    The patients' symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D).

  4. Physical activity - PAS [ Time Frame: Four years ]
    The patients' physical activity levels will be assessed a valid score; the Physical Activity scale (PAS). 6, 12 months and 3-4 years postoperatively

  5. Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS) [ Time Frame: One year ]
    The patients' symptoms will be assessed using the reliable and valid score; The Foot and Ankle Outcome Score. FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Functioning sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). Each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Assessed 6 and 12 months postoperatively

  6. Patient-reported outcome - RAND 36 Health and Quality of Life questionnaire [ Time Frame: One year ]
    The patients' symptoms will be assessed using the reliable and valid score; The RAND-36 Health and Quality of Life. The questionnaire is composed of 36 items, scored from 1 to 2,3, 5 or 6, some items are scored reversed. The score is divided in 8 subscales (dimensions) as the SF-36 questionnarie. The software recodes the points to a scale of 0 (worst) to 100 (best) for each subscale. Assessed at 6 and 12 months postoperatively

  7. Patient-reported outcome - Tampa Scale of Kinesiophobia, Swedish version, TSK-SV [ Time Frame: One year ]
    The patients' symptoms will be assessed using the reliable and valid score; The Tampa Scale of Kinesiophobia-SV. The scale comprises of 17 items and a total score is computed. 4 items are inverted and rescaled Before summation. Each item are scored from 1 (strongly disagree) to 4 (strongly agree). The total sum is between 17 to 68, where a score of more than 37 is defined as kinesiophobia. Assessed at 2 and 6 weeks and 6 and 12 months postoperatively

  8. Plantar force loading [ Time Frame: Six weeks ]
    Measured with mobile force sensors, insoles at 2 and 6 weeks postoperatively

  9. Patient-reported diary - self-reported loading [ Time Frame: Two weeks ]
    Estimation on daily self-reported loading on a VAS-scale, scored from 0 (non-weightbearing) to 100 (full weightbearing). Performed at home during the first 2 weeks postoperatively. The VAS scale is converted to percent (%) for analysis.

  10. Patient-reported diary - pain ratings [ Time Frame: Two weeks ]
    Pain ratings on a VAS-scale at home during the first week postoperatively. The patients are rating their pain from 0 (no pain) to 100 (worst imaginable pain) during activity and at rest.

  11. Patient-reported diary - steps/day [ Time Frame: Two weeks ]
    Measurement of number of steps taken each day with a valid pedometer at home during the first 2 weeks postoperatively

  12. Calf circumference [ Time Frame: Four years ]
    Measured with a tape measure at the thickest part of the calf in sitting position at 2 and 6 weeks and 6, 12 months and 3-4 years postoperatively

  13. Ankle dorsiflexion [ Time Frame: Six weeks ]
    Ankle range of motion in dorsiflexion, measured in sitting position with goniometer at 2 and 6 weeks postoperatively

  14. Tendon length measurement [ Time Frame: Four years ]
    Ultrasound measurement on Achilles tendon length, measured in centimeters, from the calcaneal bone to the gastrocnemius and the soleus muscles, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively

  15. Tendon thickness measurement [ Time Frame: One year ]
    Ultrasound measurement on Achilles tendon circumference (thickness), measured in cm2, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively

  16. Muscle volume of the calf muscles [ Time Frame: One year ]
    Ultrasound measurement on muscle volume of the calf muscles (gastrocnemius), measured in cm2, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively

  17. Thickness of the calf muscles [ Time Frame: One year ]
    Ultrasound measurement on thickness of the calf muscle (soleus). Measured in centimeter, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively

  18. Achilles Tendon resting angle (ATRA) [ Time Frame: Four years ]
    A clinical measurement of indirect Tendon length with patient prone lying, measured with goniometer with arms parallell to fibula and MTP5, measured at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively

  19. 3D gait analysis [ Time Frame: 6 months ]
    Three-dimensional gait analysis, performed at 8 weeks and 6 months postoperatively, measurement of the quality of gait


Other Outcome Measures:
  1. Tendon healing using microdialysis [ Time Frame: Two weeks ]
    Microdialysis will be followed by quantification of markers for tendon repair

  2. Time to surgery [ Time Frame: Within 10 days ]

    Prognostic factor:

    Time to surgery , i.e. the time from ATR injury to start of the surgical procedure, will be calculated by using the time-point at which the patient sustained the injury as described in the patient journal, as well as the starting time point of the surgery as registered in the computerized operation report.


  3. Surgeon sex [ Time Frame: Surgery is performed within 10 days after injury ]
    Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. Unknown sex of the operating surgeon will be included as an additional exclusion criterion in the study.

  4. Surgeon experience [ Time Frame: Surgery is performed within 10 days after injury ]
    Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. The experienced group of surgeons will consist of specialists accredited with a specialist licence issued by The Swedish National Board of Health and Welfare. The less experienced group of surgeons will consist of residents.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute unilateral ATR, operated on within 96 hours
  • Age between 18 and 75 years

Exclusion Criteria:

  • Inability to give informed consent
  • Current anticoagulation treatment (including high dose acetylsalicylic acid)
  • Planned follow-up at other hospital
  • Inability to follow instructions
  • Known kidney failure
  • Heart failure with pitting oedema
  • Thrombophlebitis
  • Thromboembolic event during the previous three months
  • Other surgery during the previous month
  • Known malignancy
  • Haemophilia; and pregnancy

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): NCT02318472


Locations
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Sweden
Karolinska university Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
OPED GmbH
Investigators
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Principal Investigator: Paul W Ackermann, MD, PhD Karolinska University Hospital
  Study Documents (Full-Text)

Documents provided by Paul Ackermann, Karolinska University Hospital:
Study Protocol  [PDF] March 23, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paul Ackermann, Associate Professor, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02318472    
Other Study ID Numbers: VR2012-2510
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Keywords provided by Paul Ackermann, Karolinska University Hospital:
Microdialysis
Patient related outcome
Heel rise test
Immobilization
functional mobilization
Ultrasound
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Rupture
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries