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Non-operative Treatment of Acute Achilles Tendon Rupture Using Dynamic Rehabilitation. Influence of Early Weight-bearing Compared With Non-weight-bearing

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ClinicalTrials.gov Identifier: NCT01470833
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : August 20, 2013
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital

Brief Summary:

Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great social benefits in optimizing treatment and shortening recovery.

There is no consensus concerning the best treatment of acute achilles tendon rupture. Traditionally, surgical treatment is considered superior, but more recent studies show evidence that non-operative treatment with early dynamic rehabilitation gives the same functional outcome with fewer side effects.

Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. It is well documented that mechanical load improves tendon healing in general and has no detrimental effect on the healing of operated achilles tendons.

The objective of this randomized study is to compare early weight-bearing with non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.


Condition or disease Intervention/treatment Phase
Acute Achilles Tendon Rupture Procedure: Early weight-bearing Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-operative Treatment of Acute Achilles Tendon Rupture Using Dynamic Rehabilitation. The Influence of Early Weight-bearing Compared With Non-weight-bearing
Study Start Date : April 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Non-weight-bearing

The group of non-weightbearing is instructed as follows:

Week 1 to 6 No weightbearing. Crutches are obligatory. Week 7 to 8 Full weightbearing is allowed.

Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.

Experimental: Early weight-bearing

The group allowed early weight-bearing is instructed as follows:

Week 1 to 2 Weightbearing is allowed with in pain limit. Crutches are recommended.

Week 3 to 4 Full weightbearing is allowed. Week 5 to 8 Full weightbearing is allowed. Crutches should be avoided.

Procedure: Early weight-bearing

The group allowed early weight-bearing is instructed as follows:

Week 1 to 2 Weight-bearing is allowed with in pain limit. Crutches are recommended.

Week 3 to 4 Full weight-bearing is allowed. Week 5 to 8 Full weight-bearing is allowed. Crutches should be avoided.

Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made.





Primary Outcome Measures :
  1. ATRS (Achilles Tendon Total Rupture Score) [ Time Frame: 1 year ]
    Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture.


Secondary Outcome Measures :
  1. Heel-rise-work test [ Time Frame: 1 year ]
    The accummulated work made doing repetetive heel-rises is messured on each leg.



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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:

  • Age 18-60 years.
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.
  • The patient should be able to follow a regimen with a removable ankle orthosis.
  • The patient must be able to determine when rupture occurred, and it can't be over 4 days old.
  • The patient should be able to follow the postoperative controls.

Exclusion Criteria:

  • Terminal illness.
  • Former achilles tendon rupture
  • Former surgery on the achilles tendon
  • Treatment with fluoroquinolones during the last 6 months.
  • Tendinosis treated with a tablet or injection with corticosteroids within the last 6 months.
  • Diagnosis of arterial insufficient in the leg.
  • Lack of palpable pulse in the foot
  • Severe medical illness: ASA score greater than 2
  • Distance from calcaneus to the rupture is less than 1 cm

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): NCT01470833


Locations
Denmark
Hvidovre Hospital
Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
DJO Incorporated
Investigators
Study Chair: Kristoffer W Barfod, Medical Doctor Hvidovre University Hospital

Responsible Party: Kristoffer Barfod, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01470833     History of Changes
Other Study ID Numbers: ASR2011
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Kristoffer Barfod, Hvidovre University Hospital:
Achilles tendon
rupture
non-operative
treatment

Additional relevant MeSH terms:
Rupture
Wounds and Injuries