Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
Artoss Inc.
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.
Description
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. The primary objective of this study is to document and analyze the use of NanoBone products in acute trauma cases (as a stand-alone bone graft, or in combination with local bo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects at least 18 years old at the time of injury 2. 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 Exclusion Criteria: 1. Certain fracture locations (these apply to non-unions as well) * Hand - metacarpals, phalanges * Forefoot - metatarsals, phalanges * Skull * Spine 2. Fractures requiring definitive fracture stabilization beyond the initial 4 weeks fro…
Interventions
- DeviceNanoBone® Bone Graft
The surgical technique used by the surgeon and the choice of the specific NanoBone product is or was determined solely by the surgeon and is independent of this observational study.
Location
- SSM Health St. Mary's HospitalMadison, Wisconsin