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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01470833
First received: November 9, 2011
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Acute Achilles Tendon Rupture
 Procedure: Early weight-bearing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • ATRS (Achilles Tendon Total Rupture Score) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture.


Secondary Outcome Measures:
  • Heel-rise-work test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The accummulated work made doing repetetive heel-rises is messured on each leg.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
  More Information

No publications provided

Responsible Party: Kristoffer Barfod, Medical Doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01470833     History of Changes
Other Study ID Numbers: ASR2011
Study First Received: November 9, 2011
Last Updated: May 21, 2012
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013