A Post Market Surveillance on INFUSE Bone Graft

Recruiting now

Conditions studied: Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease

In brief

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

Key facts

Study ID

NCT05299762

Run by

Medtronic Spinal and Biologics

People needed

600

Starts

2022-08-10

Expected to finish

2025-08-31

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Chung-Ang Gwangmyeong Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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