Actively Recruiting
Post-Market Study of INFUSE Bone Graft for Lumbar Spine Fusion in Patients with Degenerative Disc Disease in Korea
Led by Medtronic Spinal and Biologics · Updated on 2025-03-20
600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the real-world use of INFUSE174 Bone Graft for patients in Korea who require lumbar fusion surgery due to degenerative disc disease. It is a prospective, observational, multi-center post-market surveillance study designed to collect data on the safety and effectiveness of this commercially available device used as intended. The study aims to follow over 600 cases during a four-year period after approval in Korea. Participants in this study are patients treated with INFUSE174 Bone Graft via anterior ALIF or oblique OLIF lumbar interbody fusion techniques. The device is approved for use as a substitute for autogenous bone graft in patients with degenerative disc disease who have undergone at least six months of nonoperative treatment. The study observes patients who have received this device according to standard care without altering their treatment. During the study, patients will be monitored for at least 12 months after surgery. Researchers will collect information about any adverse device effects and assess fusion status within this period. Clinical outcomes such as disability index ODI, pain levels VAS, and neurological success will be recorded at multiple timepoints including 6 weeks, 3 months, 6 months, and 12 months after surgery. This comprehensive follow-up aims to provide important real-world data on patient recovery and device performance.
CONDITIONS
Brief Title
A Post Market Surveillance on INFUSE Bone Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has degenerative disc disease and needs lumbar interbody spine fusion from L2 to S1 using INFUSE174 Bone Graft via ALIF or OLIF technique
- Agrees to participate and can understand and sign informed consent
- Planned surgery follows device labeling and intended use
- Has had at least six months of nonoperative treatment before the study
- Is at least 18 years old at informed consent
You will not qualify if you...
- Has known allergy to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or device components
- Has active malignancy or treatment for cancer near surgery site
- Is skeletally immature (under 18 or no bone maturity evidence)
- Is pregnant or breastfeeding
- Has active infection at surgery site or allergy to titanium or related materials
- Use of device outside lower lumbar spine (e.g., cervical spine)
- Repeat use of device at same site
- Has Grade 1 or greater retrolisthesis
- Has liver or kidney impairment
- Has metabolic bone disease
- Has autoimmune or immunosuppressive disease or treatment
- Is illiterate or vulnerable as assessed by investigator
- Participating in another conflicting clinical study
- Has high surgical risk
- Has conditions that may compromise the study or judgment, including substance abuse as assessed by investigator
Research Team
M
Michelle Kim
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