RecruitingNCT06256458

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

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

Sponsor

Artoss Inc.

Enrollment

200 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

Fractures, Bone

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

Min Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria9

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

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Interventions

DEVICENanoBone® Bone Graft

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.