Status:
COMPLETED
Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk
Lead Sponsor:
Bioventus LLC
Conditions:
Mitigation of Fracture Non-union in Patients at Risk
Eligibility:
All Genders
21-80 years
Brief Summary
This study is one of three separate studies of the Bioventus Observational Non-interventional EXOGEN Studies (BONES) program. Eligibility for each study is determined by fractured bone.
Detailed Description
The prospective arm of this non-interventional, observational study is designed to collect real world evidence from patients at risk of a fracture non-union across the US receiving EXOGEN treatment. P...
Eligibility Criteria
Inclusion
- Must be willing to provide voluntary informed consent
- Male or female age 21-80 on fracture date
- Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment
- Fluency in English and/or Spanish
- Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture
- Bone specific fracture
Exclusion
- 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
- Pregnant on fracture index date
- 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).
- 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)
- Patient with a concurrent fracture of the other bones of interest
- Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period
- Patient report of history of primary or metastatic bone cancer
- Patient report of bone infection or osteomyelitis of index fracture at baseline contact
- Patient report of prior bone specific fracture in 9-months pre-index period
- Patient prescribed EXOGEN as part of a Worker Compensation claim
Key Trial Info
Start Date :
October 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
12387 Patients enrolled
Trial Details
Trial ID
NCT03382483
Start Date
October 16 2017
End Date
May 1 2022
Last Update
October 28 2025
Active Locations (1)
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1
CliniCallRN
Jericho, New York, United States, 11753