Ultrasound gadget may speed up bone healing in thousands
NCT ID NCT03382483
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a device called EXOGEN, which uses low-intensity ultrasound, can help broken bones heal when they are at risk of not healing properly. Over 12,000 adults with certain fractures took part. Researchers compared those who used the device plus standard care to those who had standard care alone, using insurance claims data.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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12,387 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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May 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Prospective EXOGEN Treated Patients: Adult patients (21-80 years old) in the United States (US) at risk for the development of fracture non-union who have been prescribed EXOGEN as adjunctive treatment for a specific bone fracture. Retrospective Non-EXOGEN Treated Claims Data Cohort: Adult patients (21-80 years old) in the US at risk for development of fracture non-union who are covered under commercial insurance within the MarketScan database for 18 contiguous months.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Must be willing to provide voluntary informed consent 2. Male or female age 21-80 on fracture date 3. Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment 4. Fluency in English and/or Spanish 5. Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture 6. Bone specific fracture Exclusion Criteria: 1. Patient report of treatment with an electrical bone growth stimulation device (e.g., pulsed electromagnetic field (PEMF) or capacitive coupling (CC) based devices) for bone fracture in 9-months pre-index period up to baseline phone contact 2. Pregnant on fracture index date 3. Evidence that prescription for EXOGEN has been written to treat a fracture non-union or mal-union (i.e, ICD-10-CM code with seventh character modifier of K, P or S). 4. Evidence that prescription for EXOGEN has been written to treat a pathologic fracture (ICD-10-CM code M80. or M84.) or neuropathic bone (ICD-10-CM code M14.6) 5. Patient with a concurrent fracture of the other bones of interest 6. Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period 7. Patient report of history of primary or metastatic bone cancer 8. Patient report of bone infection or osteomyelitis of index fracture at baseline contact 9. Patient report of prior bone specific fracture in 9-months pre-index period 10. Patient prescribed EXOGEN as part of a Worker Compensation claim
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CliniCallRN
Jericho, New York, 11753, United States