Actively Recruiting
A Post Market Surveillance on INFUSE Bone Graft
Led by Medtronic Spinal and Biologics · Updated on 2025-03-20
600
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
CONDITIONS
Official Title
A Post Market Surveillance on INFUSE Bone Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE17 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
You will not qualify if you...
- Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
- Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
- Is skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
- Is pregnant or lactating
- Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
- The use of the INFUSE17 Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
- Repeat applications of the INFUSE17 Bone Graft component
- Has up to Grade 1 retrolisthesis
- Has hepatic or renal impairment
- Has metabolic bone disease
- Has autoimmune disease
- Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
- Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
- Concurrent participation in another clinical study that may confound study results
- Has a considerable risk for surgery
- Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chung-Ang Gwangmyeong Hospital
Seoul, South Korea, 14353
Actively Recruiting
Research Team
M
Michelle Kim
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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