A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®

Summary of Inclusion Criteria:

1. Aged 21 to 85 years and skeletally mature at time of surgery

2. Diagnosis of degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to 25°) curvature

3. One or more of the following are met: -instability (defined a angulation greater than or equal to 5 degrees and/or translation greater than or equal 4mm based on flexion/extension radiographs, -osteophyte formation, - decreased disc height, - thickening of ligamentous tissue, disc degeneration or herniation,- facet joint degeneration

4. Requires fusion (i.e., Symptomatic) at up to two contiguous levels from L1 to S1.

5. Preoperative ODI score of more than 30

6. Non-responsive to non-operative treatment for at least 6 months.

7. Lower back pain with or without claudication.

8. If of child-bearing potential, non-pregnant, non-nursing, and agrees to use contraception for up to 2 years following surgery

9. Willing and able to comply with study plan and able to understand and sign informed consent

Summary of Exclusion Criteria

1. Primary diagnosis of a spinal disorder other than DDD, degenerative spondylolisthesis up to Grade 1 or mild degenerative scoliosis of up to 25 degrees curvature

2. Requires fusion of more than 2 vertebral levels or of 2 non-adjacent vertebral levels

3. Conditions requiring medications that interfere with fusion or bone metabolism

4. More than one immobile vertebral level between L1 and S1 from any cause

5. Overt or active local or systemic infection, including latent infection around the surgical implantation site

6. Clinically severe obesity as defined by the National Institutes of Health

7. Uncontrolled diabetes mellitus as confirmed by HbA1c greater than 8%

8. History of osteoporosis or other metabolic bone disorders, including Paget's disease and osteomalacia

9. History of hypersensitivity to any of the agents used to process OsteoAMP

10. History of autoimmune disease

11. Received other bone graft substitutes

12. Received medication that may interfere with fusion or bone metabolism within 2 weeks of planned surgery

13. Received or plans to receive investigational therapy

14. Presence of active malignancy unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 3 years

15. Presence of systemic disease or condition, which affects his/her ability to participate in the study requirements or the ability to evaluate the efficacy of the product

16. Prisoner, transient, or has been treated for chemical/alcohol dependency in an inpatient substance abuse program within 6 months prior to study enrollment or has significant psychosocial disturbance that would affect participation in the study, in the opinion of the investigator

17. Any condition for which the surgical procedure, in the opinion of the Investigator, poses an undue risk

18. Pursuing litigation related to cervical and/or lumbar/lumbosacral spine