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A Post Market Surveillance on INFUSE Bone Graft
Sponsor: Medtronic Spinal and Biologics
Summary
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2022-08-10
Completion Date
2025-08-31
Last Updated
2025-03-20
Healthy Volunteers
No
Interventions
INFUSE™ Bone Graft
Ministry of Food and Drug Safety (MFDS) has approved the INFUSE™ Bone Graft for anterior (ALIF) or oblique (OLIF) lumbar interbody spine fusion as a substitute for autogenous bone graft for patients with degenerative disc disease (DDD) who have had at least 6 months of non-operative treatment for this condition.
Locations (1)
Chung-Ang Gwangmyeong Hospital
Seoul, South Korea