Evaluating the safety and effectiveness of INFUSE Bone Graft for spinal fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chung-Ang Gwangmyeong Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Michelle Kim
• Email: michelle.kim@medtronic.com
• Phone: +82-3404-7756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.