A Post Market Surveillance on INFUSE Bone Graft

Launched by MEDTRONIC SPINAL AND BIOLOGICS · Mar 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of INFUSE™ Bone Graft, a treatment used for patients with certain spine problems, such as degenerative disc disease and lumbar disc disease. The goal is to see how well this treatment works in real-life situations in Korea. If you are between 18 and 74 years old and have been experiencing back pain that hasn't improved with at least six months of non-surgical treatment, you may be eligible to participate. To join, you also need to be planning to have a specific surgical procedure that uses this bone graft.

Participants in the trial can expect to receive the INFUSE™ Bone Graft during their surgery and will be monitored for their safety and the treatment's effectiveness over time. It's important to know that certain individuals may not qualify, such as those with allergies to specific materials in the graft, those with active cancers or infections, or those who are pregnant. If you think you might be eligible and are interested in helping to advance medical knowledge about spinal treatments, this study could be a great opportunity for you.

Gender

ALL

Eligibility 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