Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501510
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2020-07-28
Brief Title:
Ultrasonography in Fracture Management
Sponsor:
University of Warmia and Mazury
Organization:
University of Warmia and Mazury
Study Overview
Official Title:
The Use of Ultrasonography as a Diagnostic Tool for the Fracture Management
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UFrac
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 andor 8 weeks post injury comparative study
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 andor 8 weeks post injury comparative study
Detailed 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 protocolalgorithm 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 eg 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 andor 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 andor 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 Childrens Hospital in Olsztyn Poland number of approval 6 ZE2020WSSD 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 childrens participation in this study
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 eg 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 andor 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 andor 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 Childrens Hospital in Olsztyn Poland number of approval 6 ZE2020WSSD 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 childrens participation in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None