Trial record 4 of 21 for:    Open Studies | "Achilles Tendon"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hvidovre University Hospital
Sponsor:
Collaborators:
DJO Incorporated
The Danish Rheumatism Association
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT02015364
First received: December 13, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention
Achilles Tendon Rupture
Deep Vein Thrombosis
Procedure: Controlled early mobilization

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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Achilles tendon Total Rupture Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.


Secondary Outcome Measures:
  • Heel-rise work test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  • Ultrasound length measure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The length between the calcaneus and the distal tip of the medial head of the gastrocnemius muscle.

  • Cost effectiveness analysis [ Time Frame: one year ] [ Designated as safety issue: No ]
    A cost effectiveness analysis will be performed comparing the two treatment protocols.


Other Outcome Measures:
  • DVT screening [ Time Frame: 2 and 8 weeks ] [ Designated as safety issue: Yes ]
    Ultra sound for deep Vein Thrombosis (DVT) will be performed after 2 and 8 weeks


Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015364

Contacts
Contact: Kristoffer W Barfod, MD +45 61300288 kbarfod@dadlnet.dk

Locations
Denmark
Copenhagen University Hospital Hvidovre Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Kristoffer         
Sponsors and Collaborators
Hvidovre University Hospital
DJO Incorporated
The Danish Rheumatism Association
Investigators
Principal Investigator: Kristoffer W Barfod, MD Copenhagen University Hospital, Hvidovre
  More Information

No publications provided

Responsible Party: Kristoffer Barfod, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02015364     History of Changes
Other Study ID Numbers: ATR_Denmark_2014
Study First Received: December 13, 2013
Last Updated: February 7, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Hvidovre University Hospital:
Achilles tendon
Rupture
Rehabilitation
Dynamic rehabilitation

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Rupture
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014