Evaluating NanoBone® Bone Graft for Acute Trauma
Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
This study is testing how well a new bone graft called NanoBone helps people heal from acute trauma and improve their symptoms and function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artoss Inc. Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06256458 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective registry aims to document the use of NanoBone products by orthopedic surgeons in treating acute trauma cases, focusing on patient outcomes. It will assess radiographic measures such as fracture healing and instrumentation integrity, as well as clinical outcomes related to symptom and function improvement. The study will analyze both the effectiveness of NanoBone as a stand-alone graft or in combination with local bone and will track any product-related adverse events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute fractures requiring surgery due to blunt or penetrating trauma.
Not a fit: Patients with certain fracture locations, pathologic fractures, or those unable to follow post-operative plans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with acute fractures by providing evidence for the effectiveness of NanoBone® Bone Graft.
How similar studies have performed: While this approach is novel in the context of NanoBone products, similar studies evaluating bone grafts in acute trauma have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 from the date of injury 3. Pathologic fractures secondary to malignancy 4. Subjects unable to follow recommended post-operative plan and complete follow ups 5. Subjects unable to complete patient reported outcome measures
Where this trial is running
Madison, Wisconsin
- SSM Health St. Mary's Hospital — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Mitchell D Kuhl, DO — SSM Health
- Study coordinator: James J Cassidy, Ph.D.
- Email: jcassidy@artossinc.com
- Phone: 320-259-4321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.