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Artoss Foot and Ankle Surgery Registry — ARK  

Trauma Injury Clinical Trial

Official title:
Multicenter Prospective Registry to Evaluate Use and Outcomes of NanoBone in Foot and Ankle Surgery

Clinical Trial Summary

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.

Clinical Trial Description

This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, 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 foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04503759
Study type Observational [Patient Registry]
Source Artoss Inc.
Contact
Status Completed
Phase
Start date August 1, 2020
Completion date May 10, 2024
View Details
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