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A Post Market Surveillance on INFUSE Bone Graft

NCT05299762 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-03-20

No results posted yet for this study

Summary

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

Conditions

  • Intervertebral Disc Degeneration
  • Spinal Fusion
  • Lumbar Disc Disease

Interventions

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.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299762 on ClinicalTrials.gov