Phase
Condition
Spinal Surgery
Spondylolisthesis
Spine Athroplasty
Treatment
INFUSE™ Bone Graft
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has degenerative disc disease and is indicated for lumbar interbody spine fusionfrom 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 InformedConsent
The procedure planned for the patient complies with the labeling of the devices thatmay 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
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 siteis in the vicinity of a resected or extant tumor
Is skeletally immature (<18 years of age or no radiographic evidence of epiphysealclosure)
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 thelower 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 radiationtherapy, chemotherapy, steroid therapy, or other treatments
Is illiterate or vulnerable (e.g., the participant is incapable of judgment or isunder 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 ordrug abuse) as per the investigator's assessment
Study Design
Study Description
Connect with a study center
Chung-Ang Gwangmyeong Hospital
Seoul, 14353
Korea, Republic ofActive - Recruiting
Wooridul Spine Hospital
Seoul, 06068
Korea, Republic ofActive - Recruiting
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