NCT05299762

A Post Market Surveillance on INFUSE Bone Graft

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Intervertebral Disc Degeneration
• Spinal Fusion
• Lumbar Disc Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2022-03-29
• Last updated: 2025-03-20

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study