Clinical Research Directory

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.