Bone Ultrasound to Access Fracture Healing

NCT02769117 | Completed

• 1 other identifier: 15-008523
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Forearm Fracture; Clavicle Fracture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ultrasound on fractured bone

ACTIVE COMPARATOR

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

Ultrasound on contralateral intact bone

ACTIVE COMPARATOR

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

Interventions

Ultrasound on fractured bone PROCEDURE

A new ultrasound technique for children and adults who have sustained forearm or clavicle fractures

Ultrasound on fractured bone

Ultrasound on contralateral intact bone PROCEDURE

A new ultrasound technique for the intact bone as the control for children and adults who have sustained forearm or clavicle fractures

Ultrasound on contralateral intact bone

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speakers
• Known pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Todd Milbrandt, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedics and Pediatrics,

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share