Clinical trial NCT02760875: Foot Pressure Mapping and Tendon Length After Nonoperative Treatment of Acute Achilles Tendon Rupture
Official title: Foot Pressure Mapping and Ultrasound Achilles Tendon Length, in Medium Term Acute Achilles Tendon Rupture Patients Using Nonoperative Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Keywords: Achilles Tendon Rupture
Conservative treatment
early weight bearing
Achilles Tendon Length
Ultrasound
Foot Pressure Mapping
ATRA
Heel Raise Work
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Achilles Tendon Length
timeFrame: Test is performed once, 4-5 years after the initial injury
Secondary outcomes:
measure: Foot pressure mapping
timeFrame: Test is performed once, 4-5 years after the initial injury
measure: ATRA: Achilles Tendon Resting Angle
timeFrame: Test is performed once, 4-5 years after the initial injury.
measure: Passive plantar- and dorsiflextion
timeFrame: Test is performed once, 4-5 years after the initial injury
measure: circumference of the calf
timeFrame: Test is performed once, 4-5 years after the initial injury
measure: Heel Raise Work
timeFrame: Test is performed once, 4-5 years after the initial injury
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Jeannette Penny, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.