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

Mitigation of Fracture Non-union in Patients at Risk Clinical Trial

— BONES  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03382483
• Other study ID #: 16EXO401
• Secondary ID: 17EXO40217EXO403
• Status: Enrolling by invitation
• Start date: October 16, 2017
• Est. completion date: May 2022

Study information

• Verified date: February 2021
• Source: Bioventus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12387
• Est. completion date: May 2022
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Mitigation of Fracture Non-union in Patients at Risk

Intervention

Device:
• Low intensity pulsed ultrasound
bone growth stimulator

Locations

Country	Name	City	State
United States	CliniCallRN	Jericho	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bioventus LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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