Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)

Exclusion Criteria

• •More than 2 levels requiring lumbar interbody fusion
• •Spondylolisthesis greater than Grade I
• •Prior failed fusion surgery at any lumbar level(s)
• •Local or systemic infection past or present
• •Active systemic disease
• •Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
• •BMI greater than 40
• •Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
• •Use of post operative Spinal Cord Stimulator (SCS)
• •Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
• •Known or suspected history of alcohol and/or drug abuse
• •Involved in pending litigation or worker's compensation related to the spine
• •Pregnant or plans to become pregnant during the course of the study
• •Insulin-dependent diabetes mellitus
• •Known sensitivity to device materials
• •Life expectancy less than duration of study
• •Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
• •Undergoing chemotherapy or radiation treatment
• •Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)