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

NCT03382483 | Completed FDA Device

• 3 other identifiers: 16EXO40117EXO40217EXO403
• Study Type: observational
• Target: 12,387
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EXOGEN Treated

Patients prescribed EXOGEN and treatment initiated

Device: Low intensity pulsed ultrasound

Non-EXOGEN Treated

Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification

Interventions

Low intensity pulsed ultrasound DEVICE

bone growth stimulator

Also known as: EXOGEN

EXOGEN Treated

Eligibility Criteria

• Age: 21 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Must be willing to provide voluntary informed consent
• Male or female age 21-80 on fracture date
• Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment
• Fluency in English and/or Spanish
• Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture
• Bone specific fracture

You may not qualify if:

• Patient report of treatment with an electrical bone growth stimulation device (e.g., pulsed electromagnetic field (PEMF) or capacitive coupling (CC) based devices) for bone fracture in 9-months pre-index period up to baseline phone contact
• Pregnant on fracture index date
• Evidence that prescription for EXOGEN has been written to treat a fracture non-union or mal-union (i.e, ICD-10-CM code with seventh character modifier of K, P or S).
• Evidence that prescription for EXOGEN has been written to treat a pathologic fracture (ICD-10-CM code M80. or M84.) or neuropathic bone (ICD-10-CM code M14.6)
• Patient with a concurrent fracture of the other bones of interest
• Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period
• Patient report of history of primary or metastatic bone cancer
• Patient report of bone infection or osteomyelitis of index fracture at baseline contact
• Patient report of prior bone specific fracture in 9-months pre-index period
• Patient prescribed EXOGEN as part of a Worker Compensation claim

Sponsors & Collaborators

• Bioventus LLC: lead

Study Sites (1)

CliniCallRN

Jericho, New York, 11753, United States

Location

Study Officials

• Robert Zura, MD

  LSU Head of Orthopedics

  PRINCIPAL INVESTIGATOR

• Christina Mack, PhD, MPH

  IQUVIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: October 16, 2017
• Primary Completion: May 26, 2020
• Study Completion: May 1, 2022
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)