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

NCT02760875 | Completed DMC

• 1 other identifier: 16015461-2
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Rupture; Conservative treatment; early weight bearing; Achilles Tendon Length; Ultrasound; Foot Pressure Mapping; ATRA; Heel Raise Work

Outcome Measures

Primary Outcomes (1)

• Achilles Tendon Length

  Test is performed once, 4-5 years after the initial injury

Secondary Outcomes (5)

• Foot pressure mapping

  Test is performed once, 4-5 years after the initial injury

• ATRA: Achilles Tendon Resting Angle

  Test is performed once, 4-5 years after the initial injury.

• Passive plantar- and dorsiflextion

  Test is performed once, 4-5 years after the initial injury

• circumference of the calf

  Test is performed once, 4-5 years after the initial injury

• Heel Raise Work

  Test is performed once, 4-5 years after the initial injury

Study Arms (2)

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

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.

Interventions

Early weight bearing BEHAVIORAL

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.

Early Weight Bearing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Related 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.

  PMID: 25232073 BACKGROUND

Study Officials

• Jeannette Penny, MD, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)