Bone Ultrasound to Access Fracture Healing

Clavicle Fracture Clinical Trial

Official title:

Utilizing Bone Ultrasound to Access Fracture Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769117
• Other study ID #: 15-008523
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Clavicle Fracture
• Forearm Fracture
• Fractures, Bone

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

External Links

•   Mayo Clinic Clinical Trials