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Heel-unloading Orthosis for Treatment of Calcaneus Fractures

NCT03572816 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-06-28

No results posted yet for this study

Summary

Treatment of acute calcaneus fractures includes non- or partial weight bearing, but protocols are different and often not very specific. In fact, there are no studies published comparing different procedures or special supporting devices. Recently, a heel-unloading orthosis ('Settner shoe') was introduced, allowing walking by shifting the load to the middle- and forefoot. Specifically in calcaneus fractures, early regain of physical activity has been highlighted as one of the key factors for quality of life and the ability to return to work. Thus, the investigators hypothesize that mobilization with the 'Settner shoe' results in higher physical activity within the first 3 months and secondly improves ability to return to work in calcaneus fracture patients aged 18-60 years.

Conditions

  • Calcaneus Fracture
  • Orthopedic Devices Associated With Misadventures

Interventions

DEVICE

Settner shoe

custom-made heel-unloading orthosis ('Settner shoe') in aftercare of calcaneus fractures (used according to manufacturer), certified 'CE' product with more than 10 years experience

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Hagen Schmal, Prof · University Hospital Odense, Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-01-31
Completion
2021-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572816 on ClinicalTrials.gov