Freedom^® Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Only a clinical investigator can determine if you are eligible to participate in this study. At a minimum, you must meet the following key criteria:

1. Male or females, aged 21 to 65 years old, inclusive.

2. Single level, degenerative disc disease at L3 to S1, inclusive.

3. Minimum of 6 months of unsuccessful conservative treatment.

4. Oswestry Disability Questionnaire score greater than or equal to 40 out of 100 points (40/100) ODI score.

5. Low back pain VAS greater than or equal to 30 mm (3 cm).

6. Subject is a surgical candidate for an anterior approach to the lumbar spine (fewer than 3 abdominal surgeries).

7. Back pain at the operative level only (by discogram, if necessary).

8. Leg pain and/or back pain due to disc space settling, with or without radicular symptoms related to foraminal narrowing.

9. Psychosocially, mentally and physically able to comply with protocol, postoperative management, and follow-up schedule.

10. Subject must understand and sign the written Informed Consent.

1. Prior fusion at any lumbar level.

2. Clinical evidence of adjacent lumbar segment disease.

3. Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst).

4. Non-contained or extruded herniated nucleus pulposus.

5. Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of less than 8mm by CT or MR) secondary to acquired degenerative disease requiring treatment that destabilizes the spine (requiring fusion), or for subjects in whom increased motion may increase symptoms.

6. Retro- or spondylolisthesis of greater than or equal to 2.5 mm which is either fixed or present on flexion/extension films, and slippage of vertebral body where the listhesis is due to disc space settling in the absence of degenerative facets or a pars interarticularis defect.

7. Significant kyphosis (greater than 11-degrees sagittal plane deformity).

8. History of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).

9. Acute or chronic infection (local or systemic).

10. Instability or facet joint arthrosis, clinically significant.

11. Arachnoiditis.

12. Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.

13. Radiographic findings of a fused or total collapsed disc.

14. Subject using medications or drugs known to potentially interfere with bone or soft tissue healing (high-dose of steroids, osteoclast inhibitors, etc.).

15. Systemic disease affecting the spine, including rheumatoid arthritis, autoimmune disease, AIDS, HIV, or hepatitis.

16. Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed separately).

17. Psychosocial disorders (e.g. evidence or drug or alcohol abuse).

18. Morbid (extreme) obesity (BMI greater than or equal to 40 kg/m2).

19. Bone growth stimulator use in spine.

20. Investigational drug or device use within 30 days.

21. Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan if poor bone quality is suspected (T-score less than -1.0).

22. If female of childbearing potential, pregnant or interested in becoming pregnant in the next three years.

23. Type 1 diabetes, and uncontrolled (or poorly controlled) Type 2 diabetes.

24. Subjects with a history of implant rejection.

25. Provocative discography with non-concordant pain at the operative level.

26. Incarcerated subjects.

27. Myelopathy.

28. Significant leg pain of a radicular or neurogenic claudication nature.

29. Involved vertebral endplates dimensionally smaller than 34.5 mm in the medial lateral and/or 27 mm in the anterior-posterior directions.

30. Subjects not able to meet follow-up requirements.

31. Any previous or current litigation related to the spine.