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

Sponsor

Copenhagen University Hospital, Hvidovre (Other)

Overall Status

Completed

CT.gov ID

NCT02760875

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture	Behavioral: Early weight bearing

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 Design

Study Type:

Observational

Actual Enrollment :

37 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Achilles Tendon Length [Test is performed once, 4-5 years after the initial injury]

Secondary Outcome Measures

Foot pressure mapping [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.
ATRA: Achilles Tendon Resting Angle [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.
Passive plantar- and dorsiflextion [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.
circumference of the calf [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.
Heel Raise Work [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.