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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760875
• Other study ID #: 16015461-2
• Status: Completed
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2021
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Barfod KW, Bencke J, Lauridsen HB, Ban I, Ebskov L, Troelsen A. 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 Sep 17;96(18):1497-503. doi: 10.2106/JBJS.M.01273. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achilles Tendon Length		Test is performed once, 4-5 years after the initial injury
Secondary	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.	Test is performed once, 4-5 years after the initial injury
Secondary	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.	Test is performed once, 4-5 years after the initial injury.
Secondary	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.	Test is performed once, 4-5 years after the initial injury
Secondary	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.	Test is performed once, 4-5 years after the initial injury
Secondary	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.	Test is performed once, 4-5 years after the initial injury