Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
This multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the NanoBone products in acute trauma cases along with relevant patient outcomes. These outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects at least 18 years old at the time of injury
• Acute fractures, resulting from blunt or penetrating trauma
‣ In the extremities or pelvis
⁃ Requiring surgery
⁃ Treated emergently, delayed or staged up to 4 weeks from the date of injury
⁃ Where bone grafting is clinically indicated
Locations
United States
Wisconsin
SSM Health St. Mary's Hospital
RECRUITING
Madison
Contact Information
Primary
James J Cassidy, Ph.D.
jcassidy@artossinc.com
320-259-4321
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Artoss Inc.