A Post Market Surveillance on INFUSE Bone Graft
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique
• Agrees to participate in the study and is able to understand and sign the Informed Consent
• The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure
• Has at least six months of nonoperative treatment prior to the study treatment
• Is at least 18 years old at the time of informed consent
Locations
Other Locations
Republic of Korea
Chung-Ang Gwangmyeong Hospital
RECRUITING
Seoul
Contact Information
Primary
Michelle Kim
michelle.kim@medtronic.com
+82-3404-7756
Time Frame
Start Date: 2022-08-10
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 600
Treatments
Patients treated with the INFUSE™ Bone Graft
Patients intended to be treated with the INFUSE™ Bone Graft are eligible for enrollment. The investigator screen candidate patients against inclusion/exclusion criteria and enroll a patient only when all inclusion/exclusion criteria meet, and the patient provide written informed consent.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Spinal and Biologics