NCT06256458 Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma
| NCT ID | NCT06256458 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Artoss Inc. |
| Condition | Fractures, Bone |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mitchell D Kuhl, DO
PRINCIPAL INVESTIGATOR
SSM Health
Frequently Asked Questions
Who can join the NCT06256458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fractures, Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06256458 currently recruiting?
Yes, NCT06256458 is actively recruiting participants. Contact the research team at jcassidy@artossinc.com for enrollment information.
Where is the NCT06256458 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT06256458 clinical trial?
NCT06256458 is sponsored by Artoss Inc.. The principal investigator is Mitchell D Kuhl, DO at SSM Health. The trial plans to enroll 200 participants.