Trial record 14 of 21 for:    Open Studies | "Achilles Tendon"

Ultrasonographic Guided Treatment of Acute Achilles Tendon Rupture. Evaluation of Two Novel Ultrasonographic Measurements

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:
NCT02062567
First received: February 7, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

With this project the investigators wish to:

  1. Test the reproducibility of Amlang's ultrasound classification by examining the intra- and inter-rater reliability.
  2. Investigate whether Amlang's ultrasound classification is able to predict which patients are likely to develop complications when treated non-operatively.
  3. Investigate whether Barfod's length measurement is able to predict which patients are likely to develop complications when treated non-operatively.

Condition
Achilles Tendon
Rupture
Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to ATRS (the Achilles tendon Total Rupture Score).


Secondary Outcome Measures:
  • Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to the heel-rise work test.

    Heel-rise-work test: 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.



Other Outcome Measures:
  • Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Re-rupture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We whish to investigate if Amlangs ultrasound classification or Barfods length meassure can predict outcome after acute achilles tendon rupture. To do so both meassures will be correlated to the rate of re-rupture.


Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Achilles tendon rupture

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

130 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).

Criteria

Inclusion Criteria:

  • 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: NCT02062567

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

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

No publications provided

Responsible Party: Kristoffer Barfod, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02062567     History of Changes
Other Study ID Numbers: ATR_US_Denmark_2014
Study First Received: February 7, 2014
Last Updated: February 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014