Bone Ultrasound to Access Fracture Healing

NCT ID: NCT02769117

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Forearm Fracture Clavicle Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ultrasound on fractured bone

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Ultrasound on contralateral intact bone

Intervention Type PROCEDURE

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

Interventions

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Ultrasound on fractured bone

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-English speakers
* Known pregnancy
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Todd A. Milbrandt, M.D.

Associate Professor of Orthopedics and Pediatrics,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Todd Milbrandt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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15-008523

Identifier Type: -

Identifier Source: org_study_id

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