LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Inclusion Criteria

• Skeletally mature adults ≥22 and ≤80 years at the time of surgery
• Willing and able to give written informed consent and comply with study protocol and postoperative management program
• Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following:

• instability (as defined by ≥3mm translation or ≥5° angulation);
• osteophyte formation of facet joints or vertebral endplates;
• decreased disc height, on average by >2mm, but dependent upon the spinal level;
• scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
• herniated nucleus pulposus;
• facet joint degeneration/changes; and/or
• vacuum phenomenon.
• Preoperative Oswestry Disability Index score ≥ 35
• Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months
• Participant is indicated for an ALIF approach to the lumbar spine

Exclusion Criteria

• Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
• More than one level lumbar spine level requiring fusion
• Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)
• Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
• Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
• Presence of active malignancy
• Requires bone growth stimulation in the lumbar spine
• Active local or systemic infection
• Spondylolisthesis greater than Grade 1 (25% translation)
• Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis
• Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study
• Body Mass Index > 35
• Insulin-dependent diabetes mellitus
• Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
• Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)
• Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;
• Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
• In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product
• Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion
• Currently a prisoner
• Involved in active litigation relating to his/her spinal condition or workers compensation claimants.