NCT03382483

Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,387 (actual)
• Sponsor: Bioventus LLC · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Mitigation of Fracture Non-union in Patients at Risk

Interventions

Type	Name	Description
DEVICE	Low intensity pulsed ultrasound	bone growth stimulator

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-05-26
• Completion: 2022-05-01
• First posted: 2017-12-26
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study