An observational study in Achilles Tendon Rupture, sponsored by Copenhagen University Hospital, Hvidovre. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Copenhagen University Hospital, Hvidovre · Observational
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.
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 203 observational studies indexed under Rupture.
Browse Rupture studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 76 studies on the registry; 17 are open to participants now.
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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.
Exclusion Criteria:
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
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.
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.
Achilles Tendon Length
Time frame: Test is performed once, 4-5 years after the initial injury
Foot pressure mapping
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.
Time frame: Test is performed once, 4-5 years after the initial injury
ATRA: Achilles Tendon Resting Angle
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.
Time frame: Test is performed once, 4-5 years after the initial injury.
Passive plantar- and dorsiflextion
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.
Time frame: Test is performed once, 4-5 years after the initial injury
circumference of the calf
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.
Time frame: Test is performed once, 4-5 years after the initial injury
Heel Raise Work
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.
Time frame: Test is performed once, 4-5 years after the initial injury
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Hvidovre