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

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Acute Trauma Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone
• Intervention / Treatment: Device: NanoBone® Bone Graft

Detailed 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 bone only, no other bone graft substitute or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: James J Cassidy, Ph.D.; Phone Number: 320-259-4321; Email: jcassidy@artossinc.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • SSM Health St. Mary's Hospital
      • Contact: Mitchell D Kuhl, DO; Phone Number: 608-294-6464; Email: mitch.kuhl@ssmhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evidence of fracture healing	AP and lateral x-rays	2 weeks, 6 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	VAS pain score at fracture site	2 weeks, 6 weeks, 3 months, 6 months
Health status	EuroQol-5D	2 weeks, 6 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Artoss Inc.
• Investigators: Principal Investigator: Mitchell D Kuhl, DO, SSM Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: ART001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No