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

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ClinicalTrials.gov Identifier: NCT03382483
Recruitment Status : Enrolling by invitation
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC

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
Mitigation of Fracture Non-union in Patients at Risk 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 Type : Observational
Estimated Enrollment : 3000 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 : October 13, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
EXOGEN Treated
Patients prescribed EXOGEN and treatment initiated
Device: Low intensity pulsed ultrasound
bone growth stimulator
Other Name: EXOGEN

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



Primary Outcome Measures :
  1. Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk [ Time Frame: 9 month ]
    To compare incidence of fracture non-union in patients utilizing the EXOGEN device with patients receiving standard of care alone



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Prospective EXOGEN Treated Patients: Adult patients (21-80 years old) in the United States (US) at risk for the development of fracture non-union who have been prescribed EXOGEN as adjunctive treatment for a specific bone fracture.

Retrospective Non-EXOGEN Treated Claims Data Cohort: Adult patients (21-80 years old) in the US at risk for development of fracture non-union who are covered under commercial insurance within the MarketScan database for 18 contiguous months.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382483


Locations
United States, New York
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

Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT03382483     History of Changes
Other Study ID Numbers: 16EXO401
17EXO402 ( Other Identifier: Bioventus )
17EXO403 ( Other Identifier: Bioventus )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Wounds and Injuries