Ultrasonography in Fracture Management

Fractures, Bone Clinical Trial

— UFrac  

Official title:

The Use of Ultrasonography as a Diagnostic Tool for the Fracture Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501510
• Other study ID #: 61.610.022-110
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: July 2021

Study information

• Verified date: November 2020
• Source: University of Warmia and Mazury
• Contact: Anna M Kamelska-Sadowska, PhD
• Phone: +48 508163209
• Email: kamelskamedical[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

The physiological fracture healing is based on the proper facilitation of regeneration and proliferation process. The bone fracture is usually diagnosed using an X-ray examination. However, an ultrasound imaging could be used instead of the conventional imaging. It is important in the case of the youngest patients. In these cases, the Hubner protocol/algorithm is often used. The patients with suspected fracture are advised to perform an ultrasound examination. Only after the confirmation of a suspected fracture, an X-ray examination should be performed.

Bone structure show typical characteristics, which make an ultrasonography an attractive medical diagnostic tool. Highly dense tissues such as bone reflect echoes and, therefore, appear bright white on an ultrasound (reflection from the cortical surface of the bone). This allows bone to be clearly distinguished from the surrounding soft tissues.

It was shown that ultrasound is a good diagnostic tool to assess the fracture healing process. The advantage of usg is that it is non-invasive, does not use ionizing radiation and is performed in a real-time.

The first study about the ultrasound in the diagnosis of fracture was carried out in 1988 in a group of 41 newborns with suspected clavicle fractures after complicated delivery. In all cases, the collarbone fracture was easily identifiable by an ultrasound in the first few days after the injury. Moreover, these data correlated with the conventional X-ray imaging.

It was also shown that the ultrasound method in pediatric patients can be used to visualize fractures, e.g. of the ribs or the sternum. In the acute phase, disturbances in the cortical layer of the bone as well as recent hematoma are easily observed. In the later phase, the formation of a callus (callus hypertrophy) could be diagnosed.

The aim of this study is (1) to validate the ultrasound imaging method using variables such as repeatability, interclass correlation coefficient (Qw), relative standard deviation (rSD) etc.; (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 proper healing process after 2, 4, 6 and/or 8 weeks post injury (comparative study).

Ultrasound examination:

• the measurement of the humerus in two different projections (a-p and lateral). The distance from the acromion localized on the shoulder blade will be measured in order to repeat the examination in the same area.

• radial bone examination in two different projections (a-p and lateral). The distance from the radiocarpal joint space will be measured in order to repeat the examination in the same area.

• additionally, POWER Doppler assessment of callus neovascularization will be performed (each recording of the Doppler frame parameters for a given patient in order to repeat the examination at subsequent controls)

Experimental Design:

The fracture diagnosis is planned to be performed on the day of the injury, or at an interval of no more than 2-3 days post the injury as an initial examination and approx. during 8 weeks after the injury as a comparative examination (during the first control in an orthopedic clinic after 14 days, 4 weeks, 6 weeks and/or 8 weeks).

All the procedures performed in this study involving human participants will conform to the ethical guidelines of the 1975 Declaration of Helsinki (and its later amendments or comparable ethical standards, revised in 2013) and follow the Adapted Physical Activity (APA) Ethics Standard.

The protocol was approved by the Ethics Committee of Stanislaw Popowski Regional Specialized Children's Hospital in Olsztyn, Poland (number of approval: 6 ZE//2020/WSSD; date of approval: 22 May 2020).

The experiment will be conducted with the understanding of each subject. All subjects as well as their parents will give written informed consent before children's participation in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• previous injuries of a similar body area

• plaster immobilization

• fractures referred for surgery

Related Conditions & MeSH terms

• Arm Injuries
• Fractures, Bone
• Healing Fracture of Bone
• Neovascularization, Pathologic
• Upper Extremity Injury
• Vascularization

Intervention

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.

Locations

Country	Name	City	State
Poland	University of Warmia and Mazury in Olsztyn	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
University of Warmia and Mazury

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

Hübner 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. — View Citation

Maffulli N, Hughes T, Fixsen JA. Ultrasonographic monitoring of limb lengthening. J Bone Joint Surg Br. 1992 Jan;74(1):130-2. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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