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

Recruiting

• Conditions: Fractures, Bone

• Registration Number: NCT06256458
• Lead Sponsor: Artoss Inc.

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.

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 Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic evidence of fracture healing	2 weeks, 6 weeks, 3 months, 6 months	AP and lateral x-rays

Secondary Outcome Measures

Name	Time	Method
Pain relief	2 weeks, 6 weeks, 3 months, 6 months	Visual Analog Scale (VAS) pain score at fracture site. 0-10 scale, lower score means less pain.

Trial Locations

Locations (1)

SSM Health St. Mary's Hospital; 🇺🇸 Madison, Wisconsin, United States