Bone Ultrasound to Access Fracture Healing

Mayo Clinic

Status: Completed

Conditions: Forearm Fracture; Clavicle Fracture

Treatments: Procedure: Ultrasound on fractured bone; Procedure: Ultrasound on contralateral intact bone

Study type: Interventional

Funder types: Other

Identifiers

NCT02769117

15-008523

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non-English speakers
• Known pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Ultrasound on fractured bone

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound on fractured bone

Ultrasound on contralateral intact bone

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound on contralateral intact bone