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

NCT02062567 | Completed

• 1 other identifier: ATR_US_Denmark_2014
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

With this project the investigators wish to:

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

Conditions

Achilles Tendon; Rupture; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Corelation between Amlangs ultrasound classification or Barfods length meassure and ATRS

  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).

  1 year

Secondary Outcomes (1)

• Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Heel-rise-work test

  1 year

Other Outcomes (1)

• Correlation between Amlangs Ultrasound Classification or Barfods length meassure and Re-rupture

  1 year

Study Arms (1)

Acute Achilles tendon rupture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• DJO Incorporated: collaborator
• The Danish Rheumatism Association: collaborator

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

DK (1)