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

NCT03382483 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12387

Last updated 2025-10-28

No results posted yet for this study

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.

Conditions

  • Mitigation of Fracture Non-union in Patients at Risk

Interventions

DEVICE

Low intensity pulsed ultrasound

bone growth stimulator

Sponsors & Collaborators

  • Bioventus LLC

    lead INDUSTRY

Principal Investigators

  • Robert Zura, MD · LSU Head of Orthopedics

  • Christina Mack, PhD, MPH · IQUVIA

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2020-05-26
Completion
2022-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382483 on ClinicalTrials.gov