Overt or active bacterial infection, either local or systemic.
10. Has undergone systemic administration of any type of corticosteroid, anti-neoplastic,
immunostimulating, or immunosuppressive agents within 30 days prior to implantation of the assigned treatment.
11. Comorbidities precluding subject from being a surgical candidate. 12. History of autoimmune disease known to affect bone metabolism or the spine (e.g.,
spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
13. History of any endocrine or metabolic disorder known to affect osteogenesis (e.g.,
Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
14. History of exposure to any recombinant proteins used for bone formation (i.e., Infuse
Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).
15. Hypersensitivity or allergy to any components of the study treatments including, but
not limited to, bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; gentamicin or glycerol (which may be present in trace amounts in the DBM products); and/or instrumentation materials (titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or polyetheretherketone [PEEK]).
16. History of any allergy resulting in anaphylaxis. 17. Is a prisoner. 18. Is mentally incompetent. If questionable, obtain psychiatric consult. 19. Treatment with an investigational therapy (drug, device, and/or biologic) within 30
days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
20. Pregnant or nursing. Females of child-bearing potential must agree not to become
pregnant for one year following surgery.
21. Any condition that would interfere with the subject's ability to comply with study
instructions, might confound the interpretation of the study, or put the subject at risk.