Bioventus LLC is currently conducting a non-interventional observational study to demonstrate the ability of the Bone Healing System (EXOGEN) to mitigate the incidence of delayed union in patients with risk factors. The BONES (Bioventus Observational Non-interventional EXOGEN Studies) study has a unique design and was executed under the supervision and support of the FDA.
The BONES study began in October 2017 with an estimated 3,000 patients enrolled who will be monitored for 9 months after their fracture diagnosis. The study will include long and short bones of the upper and lower extremities; the patients excluded from the study will be those with diagnosed union delays, pseudoarthrosis, osteomyelitis, bone cancer, multiple fractures and pathological fractures.
After voluntary informed consent, patients aged 21 to 80 years with known risk factors and specific bone fractures were selected to use EXOGEN as an add-on treatment. The incidence of delayed union in the EXOGEN group will subsequently be compared with a retrospective cohort of patients selected from the national social security system database whose fractures were treated with the standard protocol.
As principal investigators, the BONES study has the collaboration of Dr. Robert Zura, Chief of Orthopedics at Louisiana State University and lead author of the largest nonunion study in history, and Dr. Christina Mack, PhD, head of the department of Quintiles' 'Injury Monitoring and Analysis' for the NFL and NBA.