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Bone Ultrasound to Access Fracture Healing

Primary Purpose

Forearm Fracture, Clavicle Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound on fractured bone
Ultrasound on contralateral intact bone
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forearm Fracture

Eligibility Criteria

undefined - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speakers
  • Known pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ultrasound on fractured bone

    Ultrasound on contralateral intact bone

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2016
    Last Updated
    April 24, 2023
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02769117
    Brief Title
    Bone Ultrasound to Access Fracture Healing
    Official Title
    Utilizing Bone Ultrasound to Access Fracture Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    August 1, 2018 (Actual)
    Study Completion Date
    August 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Forearm Fracture, Clavicle Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound on fractured bone
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Ultrasound on contralateral intact bone
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound on fractured bone
    Intervention Description
    A new ultrasound technique for children and adults who have sustained forearm or clavicle fractures
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound on contralateral intact bone
    Intervention Description
    A new ultrasound technique for the intact bone as the control for children and adults who have sustained forearm or clavicle fractures
    Primary Outcome Measure Information:
    Title
    Sequential fracture healing
    Description
    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.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Forearm fractures and no patients with hemiplegia -OR- Clavicle fractures Exclusion Criteria: Non-English speakers Known pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Todd Milbrandt, M.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Bone Ultrasound to Access Fracture Healing

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