An observational study in Mitigation of Fracture Non-union in Patients at Risk, sponsored by Bioventus LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by Bioventus LLC · Observational
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.
Bioventus LLC is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients prescribed EXOGEN and treatment initiated
Device: Low intensity pulsed ultrasound
Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification
bone growth stimulator
Also known as: EXOGEN
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
Time frame: 9 month
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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