Bone Ultrasound to Access Fracture Healing

Utilizing Bone Ultrasound to Access Fracture Healing

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

Study Overview

• Status: Completed
• Conditions: Clavicle Fracture; Forearm Fracture
• Intervention / Treatment: Procedure: Ultrasound on fractured bone; Procedure: Ultrasound on contralateral intact bone

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Forearm fractures and no patients with hemiplegia -OR-
• Clavicle fractures

Exclusion Criteria:

• Non-English speakers
• Known pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound on fractured bone; An ultrasound technique will be used to record the acoustic response of the fractured bone at each clinical visit until the fracture is healed. The ultrasound probe and a small hydrophone are placed on the exposed portion of the forearm on either sides of the fracture. The ultrasound intensity will be at the safe level according to the FDA regulation. Investigators will conduct the tests on the fracture and on the unaffected (contralateral) bone as the control. Typically this is at 1-, 2-, 4-, and 6- weeks following the fracture.	Procedure: Ultrasound on fractured bone; A new ultrasound technique for children and adults who have sustained forearm or clavicle fractures
Active Comparator: Ultrasound on contralateral intact bone; An ultrasound technique will be used to record the acoustic response of the intact bone as control at each clinical visit. The ultrasound probe and a small hydrophone are placed on the exposed portion of the forearm or clavicle. The ultrasound intensity will be at the safe level according to the FDA regulation. Investigators will conduct the tests on the fractured forearm/clavicle and on the unaffected (contralateral) forearm/clavicle as the control. Typically this is at 1-, 2-, 4-, and 6- weeks following the fracture.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Todd Milbrandt, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 15-008523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO