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

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ClinicalTrials.gov Identifier: NCT02062567
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
DJO Incorporated
The Danish Rheumatism Association
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital

Brief Summary:

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 or disease
Achilles Tendon Rupture Ultrasound

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears Ultrasound
U.S. FDA Resources

Group/Cohort
Acute Achilles tendon rupture



Primary Outcome Measures :
  1. Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS [ Time Frame: 1 year ]
    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 :
  1. Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test [ Time Frame: 1 year ]

    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:
  1. Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Re-rupture [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT02062567


Locations
Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
DJO Incorporated
The Danish Rheumatism Association

Responsible Party: Kristoffer Barfod, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02062567     History of Changes
Other Study ID Numbers: ATR_US_Denmark_2014
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Rupture
Wounds and Injuries