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

August 2, 2021 updated by: Rasmus Kastoft, Copenhagen University Hospital, Hvidovre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated and completed the original study:

Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the influence of early weight-bearing on clinical outcome: a blinded, randomized controlled trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early Weight Bearing

Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from day 1. The orthosis was worn 24 hours / day the first 2 weeks.

From week 2 controlled motion exercises and removal of the orthosis 5 times a day.
Behavioral: Early weight bearing
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.
control

Ankle immobilized with orthosis (DJO Nextep Contour 2 Walker) with 3 1.5 cm wedges in the heel, fixing the angle between 20-30 degrees. The orthosis was used for 8 weeks, gradually removing the wedges. Full weight bearing was allowed from week 6. The orthosis was worn 24 hours / day the first 2 weeks.

From week 2 controlled motion exercises and removal of the orthosis 5 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achilles Tendon Length
Time Frame: Test is performed once, 4-5 years after the initial injury
Test is performed once, 4-5 years after the initial injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Test is performed once, 4-5 years after the initial injury
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.
Test is performed once, 4-5 years after the initial injury.
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.
Test is performed once, 4-5 years after the initial injury
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.
Test is performed once, 4-5 years after the initial injury
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.
Test is performed once, 4-5 years after the initial injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital, Hvidovre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 1, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16015461-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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