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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12387 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-16

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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The prospective arm of this non-interventional, observational study is designed to collect real world evidence from patients at risk of a fracture non-union across the US receiving EXOGEN treatment. Patients will be followed for 9 months post fracture. As a non-interventional study, the treating clinician will continue to provide routine care without research intervention or dictation by a protocol. A medically staffed Direct-to-Patient Contact Center will serve as a central investigational site with scheduled and structured direct-to-patient contacts via phone/email/text/web based surveys to obtain informed consent and collect data directly from the patient. For all prospective patients, primary effectiveness data will be obtained directly from the medical records of the treating physician.

The comparator arm of this study will be a retrospective cohort of patients within a national health insurance claims database. An extract of this database will be taken and eligible controls derived via propensity score analysis.

Conditions

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Mitigation of Fracture Non-union in Patients at Risk

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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EXOGEN Treated

Patients prescribed EXOGEN and treatment initiated

Low intensity pulsed ultrasound

Intervention Type DEVICE

bone growth stimulator

Non-EXOGEN Treated

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

No interventions assigned to this group

Interventions

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Low intensity pulsed ultrasound

bone growth stimulator

Intervention Type DEVICE

Other Intervention Names

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EXOGEN

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Pregnant on fracture index date
3. 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).
4. 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)
5. Patient with a concurrent fracture of the other bones of interest
6. Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period
7. Patient report of history of primary or metastatic bone cancer
8. Patient report of bone infection or osteomyelitis of index fracture at baseline contact
9. Patient report of prior bone specific fracture in 9-months pre-index period
10. Patient prescribed EXOGEN as part of a Worker Compensation claim

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No