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Completed

NCT Number: NCT02760875

Foot Pressure Mapping and Tendon Length After Nonoperative Treatment of Acute Achilles Tendon Rupture

Using a population of patients from another study, who was originally randomized to 2 different types of nonoperative treatment after an acute achilles tendon rupture, the length of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed, 4-5 years after the injury.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

About this study

A total of 56 patients from an earlier study (see reference) on Achilles tendon rupture using nonoperative treatment with or without early weight bearing was invited for an additional follow up, where we examine the length of the Achilles tendon using ultrasound, as well as functional influence of the injury, using foot pressure mapping (FPM) during barefoot gait. Additionally the mobility of the ankle is measured with the Achilles Tendon Resting Angle (ATRA) as well as passive plantar- and dorsiflexion. Strength is measured using Heel Raise Work (height of lift, number of lifts and the total work), and supplemented with calf circumference.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
  • Participated and completed the original study.
  • The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion criteria

  • Terminal disease or serious illnesses with an ASA score of 3 or above.
  • Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.

Treatment and study plan

Early weight bearing

Behavioral

The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.

Primary outcomes

  1. Achilles Tendon Length

    Time frame: Test is performed once, 4-5 years after the initial injury

Secondary outcomes

  1. Foot pressure mapping

    Time frame: Test is performed once, 4-5 years after the initial injury

    Using a pressure sensitive plate, the force excerted on the floor while walking is meassured for each part of the food (such as big toe, midfoot and heel), and data is presentred in the form of peak pressure, pressure/time integral, first contact (time) and last contact (time) for each region of the foot.

  2. ATRA: Achilles Tendon Resting Angle

    Time frame: Test is performed once, 4-5 years after the initial injury.

    With the subject lying face down and the knee bent to 90 degrees, the angle between the longitudinal fibular axis and the axis of the 5. metatarsal is meassured in a relaxed state using a goniometer.

  3. Passive plantar- and dorsiflextion

    Time frame: Test is performed once, 4-5 years after the initial injury

    Using a goniometer, and performed with the patient lying face down, the maximal angle that the ankle can be pushed into, while the patient is relaxing is meassured, both in regard to plantar and dorsiflexion.

  4. circumference of the calf

    Time frame: Test is performed once, 4-5 years after the initial injury

    With the patient sitting on the side of the bench, the circumference of the calf is meassured 13 cm below the distal part of the kneecap.

  5. Heel Raise Work

    Time frame: Test is performed once, 4-5 years after the initial injury

    The total work (joules), max height of lift (mm) and number of lifts is recorded. THe patient is placed standing on one leg on a platform tilted 10 degrees (heel below toes), and is asked to lift the heel (and thereby bodyweight) as high as possible, once every 2 seconds. When the patient can no longer maintain height or pace, the test is finished.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

Foot Pressure Mapping and Ultrasound Achilles Tendon Length, in Medium Term Acute Achilles Tendon Rupture Patients Using Nonoperative Treatment.

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 4, 2016
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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