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Ultrasonography in Fracture Management

NCT04501510 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-11-05

No results posted yet for this study

Summary

The bone fracture is usually diagnosed using an X-ray examination (the method of choice). However, in the case of the youngest patients (children and adolescents), it carries a potential risk of X-ray radiation exposure. What is important, an X-ray examination often fails to detect occult fractures or the early stages of a fracture with or without bone fusion. The literature emphasizes that from 2 to 36% of fractures may be unnoticed on X-ray images (false negative results). Therefore, additional possibilities are sought to improve the initial diagnosis.

It was shown that ultrasound could be used instead of the conventional imaging. The most important advantages of the usg are the absence of radiation exposure and greater availability. Moreover, the evaluator is able to show neovascularization during usg examination, which is important in bone healing process.

The aim of this study is (1) to validate the ultrasound imaging method for the fracture management; (2) to use an ultrasound imaging to assess the bone fracture and healing process during 8 weeks post injury.

This study consists of 50 patients aged 10-18 years old. The forearm fracture will be diagnosed using an X-ray imaging as well as an ultrasound imaging in the first 3 days post injury (initial study). It is planned to assess the healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).

Conditions

  • Fractures, Bone
  • Upper Extremity Injury
  • Healing Fracture of Bone
  • Vascularization

Interventions

DIAGNOSTIC_TEST

Ultrasonographic examination validation and testing

X-ray imaging as well as the ultrasonographic examination of the fracture and healing process in children will be performed. The validation of an usg will be done.

Sponsors & Collaborators

  • University of Warmia and Mazury

    lead OTHER

Principal Investigators

  • Anna M Kamelska-Sadowska, PhD · Department of Rehabilitation and Orthopedics, Collegium Medicum, Faculty of Medicine, University of Warmia and Mazury in Olsztyn

Eligibility

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

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-02-28
Completion
2021-07-31

Countries

  • Poland

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 NCT04501510 on ClinicalTrials.gov