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

Artoss

Status: Enrolling

Conditions: Fractures, Bone

Treatments: Device: NanoBone® Bone Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT06256458

ART001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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