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| ID | Type | Description | Link |
|---|---|---|---|
| 17EXO402 | Other Identifier | Bioventus | |
| 17EXO403 | Other Identifier | Bioventus |
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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.
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. Patients will be followed for 9 months post fracture. As a non-interventional study, the treating clinician will continue to provide routine care without research intervention or dictation by a protocol. A medically staffed Direct-to-Patient Contact Center will serve as a central investigational site with scheduled and structured direct-to-patient contacts via phone/email/text/web based surveys to obtain informed consent and collect data directly from the patient. For all prospective patients, primary effectiveness data will be obtained directly from the medical records of the treating physician.
The comparator arm of this study will be a retrospective cohort of patients within a national health insurance claims database. An extract of this database will be taken and eligible controls derived via propensity score analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXOGEN Treated | Patients prescribed EXOGEN and treatment initiated |
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| Non-EXOGEN Treated | Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity pulsed ultrasound | Device | bone growth stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk | To compare incidence of fracture non-union in patients utilizing the EXOGEN device with patients receiving standard of care alone | 9 month |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Zura, MD | LSU Head of Orthopedics | Principal Investigator |
| Christina Mack, PhD, MPH | IQUVIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CliniCallRN | Jericho | New York | 11753 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2026 | |
| Reset | Apr 21, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2026 | Apr 21, 2026 |
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