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

Recruiting now

Conditions studied: Fractures, Bone

In brief

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.

Key facts

Study ID

NCT06256458

Run by

Artoss Inc.

People needed

200

Starts

2023-12-01

Expected to finish

2026-12-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SSM Health St. Mary's Hospital — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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