Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk (BONES)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03382483 |
Recruitment Status : Unknown
Verified February 2021 by Bioventus LLC.
Recruitment status was: Enrolling by invitation
First Posted : December 26, 2017
Last Update Posted : February 15, 2021
|
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 |
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 | ||||||
Change History | |||||||
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 |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Actual Enrollment |
12387 | ||||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
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 | ||||||
Removed Location Countries | |||||||
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 |
|
||||||
IPD Sharing Statement | Not Provided | ||||||
Current Responsible Party | Bioventus LLC | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Bioventus LLC | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Not Provided | ||||||
Investigators |
|
||||||
PRS Account | Bioventus LLC | ||||||
Verification Date | February 2021 |