Evaluating the safety and effectiveness of INFUSE Bone Graft for spinal fusion
A Post Market Surveillance on INFUSE Bone Graft
This study is testing how safe and effective the INFUSE Bone Graft is for spinal fusion surgery in patients in Korea over a year after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Spinal and Biologics Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05299762 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of INFUSE™ Bone Graft in a real-world setting in Korea. It is a prospective, multi-center post-market surveillance that will collect data on patients undergoing lumbar fusion using the INFUSE™ Bone Graft via Anterior Lumbar Interbody Fusion (ALIF) or Oblique Lumbar Interbody Fusion (OLIF) techniques. The study will follow at least 600 patients for a minimum of 12 months post-surgery to evaluate outcomes and adherence to the device's intended use.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with degenerative disc disease requiring lumbar interbody spine fusion using INFUSE™ Bone Graft.
Not a fit: Patients with known hypersensitivity to the components of INFUSE Bone Graft, active malignancies, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of INFUSE Bone Graft, potentially improving treatment options for patients with degenerative disc disease.
How similar studies have performed: Previous studies on similar bone grafting techniques have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine) * Repeat applications of the Infuse™ 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
Where this trial is running
Seoul
- Chung-Ang Gwangmyeong Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Michelle Kim
- Email: michelle.kim@medtronic.com
- Phone: +82-3404-7756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.