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

• ClinicalTrials.gov Identifier: NCT03382483
• Recruitment Status: Enrolling by invitation
• First Posted: December 26, 2017
• Last Update Posted: February 15, 2021
• Sponsor: Bioventus LLC
• Information provided by (Responsible Party): Bioventus LLC

Tracking Information

• First Submitted Date: December 19, 2017
• First Posted Date: December 26, 2017
• Last Update Posted Date: February 15, 2021
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: May 26, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2017)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk
• 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
• 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.

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
• Study Design: Observational Model: Other; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

• Condition: Mitigation of Fracture Non-union in Patients at Risk

Intervention

Device: Low intensity pulsed ultrasound

bone growth stimulator

Other Name: EXOGEN

Study Groups/Cohorts

• EXOGEN Treated
  Patients prescribed EXOGEN and treatment initiated
  Intervention: Device: Low intensity pulsed ultrasound
• Non-EXOGEN Treated
  Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Actual Enrollment (submitted: February 12, 2021): 12387
• Original Estimated Enrollment (submitted: December 19, 2017): 3000
• Estimated Study Completion Date: May 2022
• Actual Primary Completion Date: May 26, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03382483
• Other Study ID Numbers: 16EXO401; 17EXO402 ( Other Identifier: Bioventus ); 17EXO403 ( Other Identifier: Bioventus )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Bioventus LLC
• Study Sponsor: Bioventus LLC
• Collaborators: Not Provided

Investigators

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

• PRS Account: Bioventus LLC
• Verification Date: February 2021