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

Sponsor
Bioventus LLC (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03382483
Collaborator
(none)
12,387
Enrollment
1
Location
54.5
Anticipated Duration (Months)
227.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Low intensity pulsed ultrasound

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
12387 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
A Prospective, Patient-centric, Observational, Consecutive Enrollment, Non-interventional Study of Patients At Risk for Fracture Non-union Treated With EXOGEN Compared to a National Healthcare Claims Database Control
Actual Study Start Date :
Oct 16, 2017
Actual Primary Completion Date :
May 26, 2020
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
EXOGEN Treated

Patients prescribed EXOGEN and treatment initiated

Device: Low intensity pulsed ultrasound
bone growth stimulator
Other Names:
  • EXOGEN

    		•
    Non-EXOGEN Treated

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

    Outcome Measures

    Primary Outcome Measures

    1. Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk [9 month]

      To compare incidence of fracture non-union in patients utilizing the EXOGEN device with patients receiving standard of care alone

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CliniCallRN Jericho New York United States 11753

    Sponsors and Collaborators

    • Bioventus LLC

    Investigators

    • Principal Investigator: Robert Zura, MD, LSU Head of Orthopedics
    • Principal Investigator: Christina Mack, PhD, MPH, IQUVIA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bioventus LLC
    ClinicalTrials.gov Identifier:
    NCT03382483
    Other Study ID Numbers:
    • 16EXO401
    • 17EXO402
    • 17EXO403
    First Posted:
    Dec 26, 2017
    Last Update Posted:
    Feb 15, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Fractures, Ununited

    Study Results

    No Results Posted as of Feb 15, 2021