Overview
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
Description
This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use.
This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.
Eligibility
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