Evaluating NanoBone® Bone Graft for Acute Trauma
Official title: Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients
Run by Artoss Inc. · NCT06256458 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Artoss Inc. Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT06256458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with acute fractures requiring surgery due to blunt or penetrating trauma.
✕Probably not a fit
Patients with certain fracture locations, pathologic fractures, or those unable to follow post-operative plans may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel in the context of NanoBone products, similar studies evaluating bone grafts in acute trauma have shown promising results.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.