Prospective Registry to Evaluate Outcomes of NanoBone® Bone Graft in Acute Trauma

NCT06256458 | Recruiting DMC FDA Device

• 1 other identifier: ART001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• Radiographic evidence of fracture healing

  AP and lateral x-rays

  2 weeks, 6 weeks, 3 months, 6 months

Secondary Outcomes (1)

• Pain relief

  2 weeks, 6 weeks, 3 months, 6 months

Interventions

NanoBone® Bone Graft DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in the study will be drawn from the individual surgeons' practice. Patients will be among those already surgically treated for trauma but have not completed their standard of care follow-up as determined by the surgeon's practice. In addition, the surgeon had determined that the use of a NanoBone product was clinically necessary for the patient. The choice of a NanoBone product was independent of this research project. Only patients who have had NanoBone implanted and consent to participate and meet the inclusion-exclusion criteria will be included in the registry.

You may qualify if:

• 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

You may not qualify if:

• Certain fracture locations (these apply to non-unions as well)
• Hand - metacarpals, phalanges
• Forefoot - metatarsals, phalanges
• Skull
• Spine
• Fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury
• Pathologic fractures secondary to malignancy
• Subjects unable to follow recommended post-operative plan and complete follow ups
• Subjects unable to complete patient reported outcome measures

Sponsors & Collaborators

• Artoss Inc.: lead

Study Sites (1)

SSM Health St. Mary's Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Mitchell D Kuhl, DO

  SSM Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Cassidy, Ph.D.

CONTACT

320-259-4321; jcassidy@artossinc.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)