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Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization

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ClinicalTrials.gov Identifier: NCT02015364
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
DJO Incorporated
The Danish Rheumatism Association
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital

Brief Summary:

Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture.

Type of study

Randomized, controlled trial (RCT). 130 patients will be included.

Time schedule

Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years

Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed.

Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups:

  1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3.
  2. The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.

Treatment protocol for the two groups is similar concerning orthose, removal of wedges and weight-bearing. The only difference is that patients in the intervention group are instructed to do ankle exercise.

Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12 months. The study's primary endpoint is at the 12 month mark.

Population Patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint).

Number of patients 65 patients will be included in each group (a 130 patients in total).


Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Deep Vein Thrombosis Procedure: Controlled early mobilization Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-operative Treatment of Acute Achilles Tendon Rupture, Early Controlled Mobilization Compared With Immobilization: A Blinded Randomized, Controlled Trial
Study Start Date : February 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Controlled early mobilization
The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 to 8
Procedure: Controlled early mobilization
1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.

No Intervention: Immobilization
The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.



Primary Outcome Measures :
  1. Achilles tendon Total Rupture Score [ Time Frame: 12 months ]
    A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.


Secondary Outcome Measures :
  1. Achilles tendon Total Rupture Score [ Time Frame: 6 months ]
    A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.

  2. Achilles tendon Total Rupture Score [ Time Frame: 24 months ]
    A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.

  3. Heel-rise work test [ Time Frame: 6 months ]
    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. The results are then compared to the weight of the patient and the total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used

  4. Heel-rise work test [ Time Frame: 12 months ]
    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. The results are then compared to the weight of the patient and the total work is estimated. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used

  5. Single heel-rise test [ Time Frame: 6 months ]
    The patient stands with the foot in 10 degrees of dorsiflexion. It is recorded whether the patient is able to make a single heel-rise on the injured leg. The heel-rise is acknowledged if the heel can be lifted at least 2 cm with stretched knee. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used

  6. Single heel-rise test [ Time Frame: 12 months ]
    The patient stands with the foot in 10 degrees of dorsiflexion. It is recorded whether the patient is able to make a single heel-rise on the injured leg. The heel-rise is acknowledged if the heel can be lifted at least 2 cm with stretched knee. The MuscleLab ® (Ergo Test Technology, Oslo, Norway) measurement system is used

  7. Ultrasound length measure [ Time Frame: 6 months ]
    The length between the calcaneus and the distal tip of the medial head of the gastrocnemius muscle.

  8. Ultrasound length measure [ Time Frame: 12 months ]
    The length between the calcaneus and the distal tip of the medial head of the gastrocnemius muscle.

  9. Cost effectiveness analysis [ Time Frame: 12 months ]
    A cost effectiveness analysis will be performed comparing the two treatment protocols.

  10. Re-rupture [ Time Frame: 12 months ]
  11. Re-rupture [ Time Frame: 24 months ]
  12. Perimeter of calf [ Time Frame: 6 months ]
  13. Perimeter of calf [ Time Frame: 12 months ]
  14. Return to work [ Time Frame: 6 months ]
  15. Return to work [ Time Frame: 12 months ]
  16. Return to work [ Time Frame: 24 months ]
  17. Return to sports [ Time Frame: 6 months ]
  18. Return to sports [ Time Frame: 12 months ]
  19. Return to sports [ Time Frame: 24 months ]
  20. Achilles Tendon Resting Angle (ATRA) [ Time Frame: 6 months ]
  21. Achilles Tendon Resting Angle (ATRA) [ Time Frame: 12 months ]
  22. Achilles Tendon Length Measure (ATLM) [ Time Frame: 6 months ]
  23. Achilles Tendon Length Measure (ATLM) [ Time Frame: 12 months ]
  24. Plantarflexion power [ Time Frame: 6 months ]
    Plantarflexion power is measured with a hand held dynamometer fixed to the examination bed with a strong Velcro band.

  25. Plantarflexion power [ Time Frame: 12 months ]
    Plantarflexion power is measured with a hand held dynamometer fixed to the examination bed with a strong Velcro band.


Other Outcome Measures:
  1. DVT screening [ Time Frame: 2 and 8 weeks ]
    Ultra sound for deep Vein Thrombosis (DVT) will be performed after 2 and 8 weeks



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rupture happened within 5 days.
  • Age 18-70 years.
  • 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:

  • Former rupture of one or both Achilles tendon(s).
  • Previous surgery on the Achilles tendon.
  • Fluoroquinolone treatment within the last 6 months.
  • Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
  • The patient has been diagnosed with arterial insufficiency in the legs.
  • Terminal illness or severe medical illness: ASA score higher than or equal to 3.
  • The space between the rupture and the calcaneus is less than 1cm.

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): NCT02015364


Locations
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Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
DJO Incorporated
The Danish Rheumatism Association
Investigators
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Principal Investigator: Kristoffer W Barfod, MD Copenhagen University Hospital, Hvidovre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristoffer Barfod, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02015364    
Other Study ID Numbers: ATR_Denmark_2014
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Kristoffer Barfod, Hvidovre University Hospital:
Achilles tendon
Rupture
Rehabilitation
Dynamic rehabilitation
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Rupture
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries