Phase
Condition
N/ATreatment
Low intensity pulsed ultrasound
Clinical Study ID
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 pathologicfracture (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
Study Description
Connect with a study center
CliniCallRN
Jericho, New York 11753
United StatesSite Not Available
CliniCallRN
Jericho 5122638, New York 5128638 11753
United StatesSite Not Available

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