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Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805751
Recruitment Status : Unknown
Verified June 2016 by Pernilla Eliasson, Linkoeping University.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
University Hospital, Linkoeping
Information provided by (Responsible Party):
Pernilla Eliasson, Linkoeping University

Brief Summary:

The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).

The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.


Condition or disease Intervention/treatment Phase
Tendon Injuries Soft Tissue Injuries Achilles Tendon Rupture Device: Early loading on a training pedal Other: Tendon strain exercises Other: Early weight bearing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading
Study Start Date : October 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Control
This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
Other: Tendon strain exercises
The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

Other: Early weight bearing
The patients are allowed to bear weight as much as tolerated in the walker from day 1.

Experimental: Early loading
The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).
Device: Early loading on a training pedal
The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.

Other: Tendon strain exercises
The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

Other: Early weight bearing
The patients are allowed to bear weight as much as tolerated in the walker from day 1.




Primary Outcome Measures :
  1. Modulus of Elasticity [ Time Frame: 19 weeks ]
    Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.


Secondary Outcome Measures :
  1. Tendon elongation [ Time Frame: 2, 7, 19 and 52 weeks after rupture ]
    Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads

  2. Modulus of Elasticity [ Time Frame: 7 and 52 weeks after rupture ]
    Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.

  3. Achilles tendon total rupture score (ATRS) [ Time Frame: 19 and 52 weeks after rupture ]
    Patient reported outcome regarding function in their Achilles tendon

  4. Maximal range of motion [ Time Frame: 19 and 52 weeks after rupture ]
    The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.

  5. Heel-rise [ Time Frame: 19 and 52 weeks after rupture ]
    The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.

  6. Plastic deformation of the tendon [ Time Frame: 7 weeks after rupture ]
    Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.

  7. Calf muscle circumference [ Time Frame: 19 and 52 weeks ]


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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:

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury
  • 18-60 years old

Exclusion Criteria:

  • Inability to understand swedish
  • previous injured tendon
  • Diabetes mellitus
  • History of Rheumatoid disease
  • Treatment with steroids

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): NCT02805751


Contacts
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Contact: Pernilla Eliasson, PhD 0046-721887127 pernilla.eliasson@liu.se
Contact: Per Aspenberg, MD, PhD +46101034166 per.aspenberg@liu.se

Locations
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Sweden
University Hospital Linkoeping Recruiting
Linkoping, Ostergotland, Sweden, 58729
Contact: Pernilla Eliasson, PhD    0046-721887127    pernilla.eliasson@liu.se   
Contact: Per Aspenberg, MD, PhD    0046-101034166    per.aspenberg@liu.se   
Sponsors and Collaborators
Linkoeping University
University Hospital, Linkoeping
Investigators
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Study Director: Per Aspenberg, MD, PhD Linkoping University
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Responsible Party: Pernilla Eliasson, Postdoc, Linkoeping University
ClinicalTrials.gov Identifier: NCT02805751    
Other Study ID Numbers: Early loading
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pernilla Eliasson, Linkoeping University:
Achilles
Tendon
Loading
Rehabilitation
Additional relevant MeSH terms:
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Wounds and Injuries
Rupture
Tendon Injuries
Soft Tissue Injuries