Mitigation of Fracture Non-union in Patients at RiskBONESNCT03382483
Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk
An observational study of Mitigation of Fracture Non-union in Patients at Risk, run by Bioventus LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Mitigation of Fracture Non-union in Patients at Risk
- What is being tested?
- Low intensity pulsed ultrasound
- Type of treatment
- Medical device
- How many people
- 12,387 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Must be willing to provide voluntary informed consent
- Male or female age 21-80 on fracture date
- Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment
- Fluency in English and/or Spanish
- Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture
- Bone specific fracture
Who cannot join
- 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
- Pregnant on fracture index date
- 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).
- 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)
- Patient with a concurrent fracture of the other bones of interest
- Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period
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- Patient report of history of primary or metastatic bone cancer
- Patient report of bone infection or osteomyelitis of index fracture at baseline contact
- Patient report of prior bone specific fracture in 9-months pre-index period
- Patient prescribed EXOGEN as part of a Worker Compensation claim
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Low intensity pulsed ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity pulsed ultrasoundDevice
Also called EXOGEN
bone growth stimulator
| Study group | Role | What they receive |
|---|---|---|
| EXOGEN Treated | Patients prescribed EXOGEN and treatment initiated Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start16 Oct 2017
- Primary completion26 May 2020
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitigation of Fracture Non-union in Patients at RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 12,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Zura, MD, Principal investigator, LSU Head of OrthopedicsChristina Mack, PhD, MPH, Principal investigator, IQUVIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382483
- Sponsor's protocol ID
- 16EXO401
- Other IDs
- 17EXO402, 17EXO403
- Acronym
- BONES
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2017
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03382483
- Acronym / sponsor ID
- BONES / 16EXO401
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,387 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXOGEN Treated | – | Device: Low intensity pulsed ultrasoundPatients prescribed EXOGEN and treatment initiated |
| Non-EXOGEN Treated | – | –Patients in insurance claims database who have not been treated with a bone growth stimulator; derived via propensity score subclassification |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Must be willing to provide voluntary informed consent
- Male or female age 21-80 on fracture date
- Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment
- Fluency in English and/or Spanish
- Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture
Key exclusion criteria (10 listed)
- 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
- Pregnant on fracture index date
- 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).
- 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)
- Patient with a concurrent fracture of the other bones of interest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity pulsed ultrasoundAlso: EXOGENbone growth stimulator | Device | EXOGEN Treated |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zura, MD principal investigator
LSU Head of Orthopedics
Christina Mack, PhD, MPH principal investigator
IQUVIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitigation of Fracture Non-union in Patients at Risk, run by Bioventus LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjunctive treatment with low intensity pulsed ultrasound therapy mitigates the risk of fracture non-union in patients at risk (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.