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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mitigation of Fracture Non-union in Patients at Risk
• Intervention / Treatment: 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
• Enrollment (Actual): 12387

Contacts and Locations

Study Locations

• United States
  • New York
    • Jericho, New York, United States, 11753
      • CliniCallRN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk	To compare incidence of fracture non-union in patients utilizing the EXOGEN device with patients receiving standard of care alone	9 month

Collaborators and Investigators

• Sponsor: Bioventus LLC
• Investigators: Principal Investigator: Robert Zura, MD, LSU Head of Orthopedics; Principal Investigator: Christina Mack, PhD, MPH, IQUVIA

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): May 26, 2020
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Ununited
• Other Study ID Numbers: 16EXO401; 17EXO402 (Other Identifier: Bioventus); 17EXO403 (Other Identifier: Bioventus)

Drug and device information, study documents

• 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