A Post Market Surveillance on INFUSE Bone Graft

Status Recruiting

Clinical Trial Summary

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

Clinical Trial Description

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use. This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05299762
Study type	Observational
Source	Medtronic Spinal and Biologics
Contact	Michelle Kim
Phone	+82-3404-7756
Email	michelle.kim@medtronic.com
Status	Recruiting
Phase
Start date	August 10, 2022
Completion date	August 31, 2025

View Details

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