Phase 2 study

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

1. Skeletally mature adults ≥22 and ≤80 years at the time of surgery

2. Willing and able to give written informed consent and comply with study protocol and postoperative management program

3. 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.

4. Preoperative Oswestry Disability Index score ≥ 35

5. Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months

6. Participant is indicated for an ALIF approach to the lumbar spine

Exclusion Criteria:

1. Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
2. More than one level lumbar spine level requiring fusion
3. Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)
4. 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.
5. Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
6. Presence of active malignancy
7. Requires bone growth stimulation in the lumbar spine
8. Active local or systemic infection
9. Spondylolisthesis greater than Grade 1 (25% translation)
10. Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
11. 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
12. 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
13. Body Mass Index > 35
14. Insulin-dependent diabetes mellitus
15. Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
16. 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)
17. Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;
18. Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
19. 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
20. 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
21. Currently a prisoner
22. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.