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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02769117
Other study ID # 15-008523
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date August 1, 2018

Study information

Verified date April 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate sequential fracture healing with radius/ulna fractures or clavicle fractures and compare ultrasound to radiographs.


Description:

Investigators will recruit 60 pediatric and adult patients with complete radius, ulna and/or clavicle fractures and obtain ultrasound data from the fractured bones and the contralateral intact bone (as control) at each clinical visit. Ultrasound will be compared to radiographs. Completion of this aim will validate the concept and correlate clinical healing with ultrasound findings. For the ultrasound method, investigators will use ultrasound energy to produce a secondary mechanical vibration in bone that can be used to characterize the integrity of the bone. (This is in contrast with conventional sonography where ultrasound echoes are used to image the tissue.) The proposed method is based on the use of Ultrasound Radiation Force (URF) to excite the bone. URF is a "pushing" force exerted by ultrasound on an object. This force can be static, transient (pulse), or harmonic. Harmonic URF can be generated by modulating the amplitude of the ultrasound beam at a desired frequency. This force initiates bone vibration, where the frequency and amplitude of such vibrations depend on bone geometry and elastic properties. Hence, any fracture (or fracture repair) will alter the vibration pattern, thus enabling us to monitor fracture and fracture healing by analyzing such patterns.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 99 Years
Eligibility Inclusion Criteria: - Forearm fractures and no patients with hemiplegia -OR- - Clavicle fractures Exclusion Criteria: - Non-English speakers - Known pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound on fractured bone
A new ultrasound technique for children and adults who have sustained forearm or clavicle fractures
Ultrasound on contralateral intact bone
A new ultrasound technique for the intact bone as the control for children and adults who have sustained forearm or clavicle fractures

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Sequential fracture healing Ultrasound results will be compared between the fractured and unaffected extremity. This comparison allows investigators to compensate for variations in bone size, geometry, and surrounding muscles, thus calibrating the measurements to individual patient. The hypothesis is that the acoustic response of the fractured bone approaches to that of the unaffected bone as the fracture heals. Therefore, by comparing the test results obtained from the fractured and unaffected bone it is possible to evaluate the status of bone fracture and its healing level. In this process, investigators will correlate the results of ultrasound tests to clinical findings (e.g., radiographs) to validate the results from the ultrasound tests. 5 years
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