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

NCT01470833 | Completed

• 1 other identifier: ASR2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Achilles Tendon Rupture

Keywords

Achilles tendon; rupture; non-operative; treatment

Outcome Measures

Primary Outcomes (1)

• ATRS (Achilles Tendon Total Rupture Score)

  Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture.

  1 year

Secondary Outcomes (1)

• Heel-rise-work test

  1 year

Study Arms (2)

Non-weight-bearing

NO INTERVENTION

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.

Early weight-bearing

EXPERIMENTAL

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

Interventions

Early weight-bearing PROCEDURE

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.

Early weight-bearing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• DJO Incorporated: collaborator

Study Sites (1)

Hvidovre Hospital

Copenhagen, 2650, Denmark

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kristoffer W Barfod, Medical Doctor

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

DK (1)