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

NCT ID: NCT02760875

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Achilles Tendon Rupture

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Early weight bearing

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Kastoft

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeannette Penny, MD, PhD

Role: STUDY_DIRECTOR

Copenhagen University Hospital, Hvidovre

Locations

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Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 25232073 (View on PubMed)

Other Identifiers

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16015461-2

Identifier Type: -

Identifier Source: org_study_id

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