Last updated: February 12, 2021
Sponsor: Bioventus LLC
Overall Status: Active - Enrolling
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT03382483
16EXO401
17EXO403
17EXO402
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 fromthe 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
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) forbone 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-unionor 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 theUS 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 baselinecontact
- Patient report of prior bone specific fracture in 9-months pre-index period
- Patient prescribed EXOGEN as part of a Worker Compensation claim
Study Design
Total Participants: 12387
Study Start date:
October 16, 2017
Estimated Completion Date:
May 31, 2022
Study Description
Connect with a study center
CliniCallRN
Jericho, New York 11753
United StatesSite Not Available
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