NCT04439032

Artoss Prospective Spine Registry Outcomes

Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone® Bone Graft Substitute in Spinal Fusion Surgery

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: Artoss Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.

Detailed description

This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outcomes include radiographic measures such as fusion outcome, 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 spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other BGS or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Conditions

• Spinal Fusion

Interventions

Type	Name	Description
OTHER	NanoBone Bone Graft Substitute	Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.

Timeline

• Start date: 2020-08-03
• Primary completion: 2024-10-31
• Completion: 2025-06-30
• First posted: 2020-06-19
• Last updated: 2025-02-12

Locations

6 sites across 1 country: United States