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Artoss Prospective Spine Registry Outcomes — ASTRO  

Spinal Fusion Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04439032
Study type Observational
Source Artoss Inc.
Contact
Status Active, not recruiting
Phase
Start date August 3, 2020
Completion date December 2024
View Details
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