A Study of LDGraft In Single Level Lumbar Interbody Fusion (AMBITION)

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 requiring fusion confirmed by patient history and radiographic imaging
• 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

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
• 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 2 (50% translation)
• Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping)
• 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 or receiving radiation therapy that is expected to continue for the duration of the study
• Body Mass Index > 40
• Insulin-dependent diabetes mellitus
• Osteopenia or osteoporosis of the spine
• Any secondary causes of osteoporosis or other conditions known to adversely affect osteogenesis
• 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 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
• Currently a prisoner
• Involved in active litigation relating to his/her spinal condition or workers compensation claimants.