CompletedNot Applicable

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

United States12,387 participantsStarted 2017-10-16

Plain-language 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.

Who can participate

Age range

21 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk

Timeframe: 9 month

Trial details

NCT IDNCT03382483

SponsorBioventus LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-05-26

View on ClinicalTrials.gov More Mitigation of Fracture Non-union in Patients at Risk trials