Back to Trials
NCT06256458Recruiting

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

Artoss Inc.

Start Date

12/1/2023

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

NanoBone® Bone Graft

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Fractures, Bone

Locations

SSM Health St. Mary's Hospital

Madison, Wisconsin 53715

United States