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 range21 Years – 80 Years

SexALL

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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)
✕. 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

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