Trial record 6 of 1559 for:    "Mayo Clinic" [Exact]

Bone Ultrasound to Access Forearm Fracture Healing

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Todd A. Milbrandt, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02769117
First received: May 6, 2016
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to evaluate sequential fracture healing with radius/ulna fractures and compare ultrasound to radiographs.

Condition Intervention
Forearm Fracture
Procedure: Ultrasound on fractured bone
Procedure: Ultrasound on contralateral intact bone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Utilizing Bone Ultrasound to Access Forearm Fracture Healing

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Sequential fracture healing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 forearm 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 fractured forearm and on the unaffected (contralateral) forearm 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 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. The ultrasound intensity will be at the safe level according to the FDA regulation. Investigators will conduct the tests on the fractured forearm and on the unaffected (contralateral) forearm 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 fractures

Detailed Description:
Investigators will recruit 60 pediatric and adult patients with complete radius and/or ulna 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.
  Eligibility

Ages Eligible for Study:   up to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Forearm fractures and no patients with hemiplegia

Exclusion Criteria:

  • Non-English speakers
  • Known pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02769117

Contacts
Contact: Vickie Treder (507) 538-3561 treder.vickie@mayo.edu

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Todd Milbrandt, M.D. Mayo Clinic
  More Information

Responsible Party: Todd A. Milbrandt, M.D., Associate Professor of Orthopedics and Pediatrics,, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02769117     History of Changes
Other Study ID Numbers: 15-008523 
Study First Received: May 6, 2016
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2016