Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk (BONES)
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|ClinicalTrials.gov Identifier: NCT03382483|
Recruitment Status : Unknown
Verified December 2017 by Bioventus LLC.
Recruitment status was: Enrolling by invitation
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment|
|Mitigation of Fracture Non-union in Patients at Risk||Device: Low intensity pulsed ultrasound|
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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||A Prospective, Patient-centric, Observational, Consecutive Enrollment, Non-interventional Study of Patients At Risk for Fracture Non-union Treated With EXOGEN Compared to a National Healthcare Claims Database Control|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patients prescribed EXOGEN and treatment initiated
Device: Low intensity pulsed ultrasound
bone growth stimulator
Other Name: EXOGEN
Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification
- Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk [ Time Frame: 9 month ]To compare incidence of fracture non-union in patients utilizing the EXOGEN device with patients receiving standard of care alone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382483
|United States, New York|
|Jericho, New York, United States, 11753|
|Principal Investigator:||Robert Zura, MD||LSU Head of Orthopedics|
|Principal Investigator:||Christina Mack, PhD, MPH||IQUVIA|