Ultrasonography in Fracture Management

NCT04501510 | Unknown

• 1 other identifier: 61.610.022-110
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ultrasonography; bone; fracture; x-ray; injury; upper extremity; humerus; radius; vascularization; Doppler

Outcome Measures

Primary Outcomes (4)

• Mean Change from Baseline in fracture management using x-ray imaging and medical ultrasound within 8 weeks post-injury

  The confirmation of fracture and healing process

  through study completion, an average of 1 year

• Mean Change from Baseline in adhesions development using medical ultrasound within 8 weeks post-injury

  The assessment of the development of adhesions (changes in soft tissue image)

  through study completion, an average of 1 year

• Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury

  Mean Change from Baseline in vascularization on POWER Doppler within 8 weeks post-injury

  through study completion, an average of 1 year

• Mean Change from Baseline in Pain Scores on the Visual Analog Scale within 8 weeks post-injury

  The changes in pain scale will be assessed using Visual Analogue Scale (VAS) and other specific for the selected injuries. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' (from mild to severe pain).

  through study completion, an average of 1 year

Study Arms (2)

HumerusFracture

Patients with humerus fracture

Diagnostic Test: Ultrasonographic examination validation and testing

RadiusFracture

Patients with radial bone fracture

Diagnostic Test: Ultrasonographic examination validation and testing

Interventions

Ultrasonographic examination validation and testing DIAGNOSTIC_TEST

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.

HumerusFracture; RadiusFracture

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 patients admitted to the Orhopaedics and Trauma Ward of Prof. dr Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland with trauma to the upper extremity (from the proximal of the wrist to distal of the glenohumeral joint with evidence of pain, tenderness or swelling of the limb). Patients will be devided into two groups of radius or humerus bone (RadiusFracture and HumerusFracture groups). All patients will be recruited starting from July 2020. In all patients, first ultrasound and then standard plain radiography will be performed.

You may qualify if:

• the proximal end of the humerus and the distal end of the radius bones fractures
• voluntary participation and consent to participate in the study signed by the parent and patient
• declaration of participation in an X-ray and ultrasound examination during all 8 weeks post-injury
• no medical contraindications to participate in the study program

You may not qualify if:

• previous injuries of a similar body area
• plaster immobilization
• fractures referred for surgery

Sponsors & Collaborators

• University of Warmia and Mazury: lead

Study Sites (1)

University of Warmia and Mazury in Olsztyn

Olsztyn, 10-719, Poland

RECRUITING

Related Publications (4)

• Maffulli N, Hughes T, Fixsen JA. Ultrasonographic monitoring of limb lengthening. J Bone Joint Surg Br. 1992 Jan;74(1):130-2. doi: 10.1302/0301-620X.74B1.1732241.

  PMID: 1732241 BACKGROUND

• Cho KH, Lee SM, Lee YH, Suh KJ. Ultrasound diagnosis of either an occult or missed fracture of an extremity in pediatric-aged children. Korean J Radiol. 2010 Jan-Feb;11(1):84-94. doi: 10.3348/kjr.2010.11.1.84. Epub 2009 Dec 28.

  PMID: 20046499 BACKGROUND

• Malahias MA, Manolopoulos PP, Kadu V, Shahpari O, Fagkrezos D, Kaseta MK. Bedside Ultrasonography for Early Diagnosis of Occult Radial Head Fractures in Emergency Room: A CT-Comparative Diagnostic Study. Arch Bone Jt Surg. 2018 Nov;6(6):539-546.

  PMID: 30637310 BACKGROUND

• Hubner U, Schlicht W, Outzen S, Barthel M, Halsband H. Ultrasound in the diagnosis of fractures in children. J Bone Joint Surg Br. 2000 Nov;82(8):1170-3. doi: 10.1302/0301-620x.82b8.10087.

  PMID: 11132281 BACKGROUND

Related Links

• Erik Beek and Rick R van Rijn (eds). Diagnostic Pediatric Ultrasound

MeSH Terms

Conditions

Fractures, Bone; Arm Injuries; Neovascularization, Pathologic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna M Kamelska-Sadowska, PhD

  Department of Rehabilitation and Orthopedics, Collegium Medicum, Faculty of Medicine, University of Warmia and Mazury in Olsztyn

  STUDY CHAIR

Central Study Contacts

Anna M Kamelska-Sadowska, PhD

CONTACT

+48 508163209; kamelskamedical@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 6, 2020
• Study Start: November 2, 2020
• Primary Completion: February 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

PL (1)