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

Last updated: February 11, 2025
Sponsor: Artoss Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

NanoBone® Bone Graft

Clinical Study ID

NCT06256458
ART001
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  1. Certain fracture locations (these apply to non-unions as well)

  • Hand - metacarpals, phalanges

  • Forefoot - metatarsals, phalanges

  • Skull

  • Spine

  1. Fractures requiring definitive fracture stabilization beyond the initial 4 weeksfrom the date of injury

  2. Pathologic fractures secondary to malignancy

  3. Subjects unable to follow recommended post-operative plan and complete follow ups

  4. Subjects unable to complete patient reported outcome measures

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: NanoBone® Bone Graft
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • SSM Health St. Mary's Hospital

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

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