DIAM™ Spinal Stabilization System Clinical Trial

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. Low back pain defined as persistent back pain, with or without radicular (leg) pain, of less than one year duration

2. Diagnoses of degenerative disc disease at single level between L2-L5

3. Between 18-70 years of age

4. At least 6 weeks, but no more than 6 months, of non-operative treatment prior to enrollment

5. Not pregnant or planning a pregnancy during the study

6. Willing and able to participate in either of the randomized treatments for the duration of the study follow up period

7. All potential candidates are subject to the above and additional non-listed clinical trial criteria

1. Primary diagnosis of a spinal disorder other than DDD at involved level

2. Requires treatment of DDD at more than one lumbar level

3. Had all of the following nonoperative treatments (prescribed medications, active physical therapy, spinal injections, and patient education) within past 6 weeks

4. Sequestered herniated nucleus pulposus

5. Any previous surgery at involved or adjacent spinal levels

6. Any intradiscal ablation therapy

7. Congenital or iatrogenic posterior element insufficiency

8. Back pain (with or without leg, buttock, or groin pain) not alleviated in any spinal position

9. Lower extremity motor deficit

10. Cauda equina syndrome

11. Compression of nerve roots with neurogenic bowel (fecal incontinence) or bladder (urinary retention or incontinence) dysfunction

12. Previously diagnosed with clinically significant peripheral neuropathy

13. Significant vascular disease causing vascular claudication

14. Medical contraindication that prevents patient from receiving spinal injections

15. Ventral spondylolisthesis with > 2 mm of translation at the involved level

16. Evidence of prior fracture or trauma to L1-L5 levels in either compression or burst

17. Lumbar scoliosis with Cobb angle > 15°

18. Lumbar kyphosis or flat back syndrome

19. Sustained a hip fracture within last year

20. Any of the following (if "Yes" to any of below, a lumbar spine DEXA Scan will be required to determine eligibility):

a) Previous diagnosis of osteoporosis, osteopenia, or osteomalacia
b) Postmenopausal Non-Black female over age 60 weighing <140 pounds
c) Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture
d) Male over age 60 who has sustained non-traumatic hip or spine fracture If DEXA T-score is -1.0 or lower, the patient is excluded from the study

21. BMI greater than or equal to 40

22. Documented allergy to silicone, polyethylene, titanium, or latex

23. Overt or active bacterial infection and/or potential for bacteremia

24. Suppressed immune system or has taken steroids daily for more than one month within last year

25. History of autoimmune disease

26. Active malignancy or history of malignancy (except for basal cell carcinoma of the skin)

27. History of endocrine or metabolic disorder affecting osteogenesis

28. Chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease

29. Disease that would preclude accurate clinical evaluation of the safety and effectiveness of study treatment

30. Treatment with an investigational therapy within 30 days prior to entering study or such treatment is planned during the 24 months following enrollment in study

31. Alcohol and/or drug abuser

32. Mentally incompetent

33. Waddell Signs of Inorganic Behavior score of greater than or equal to 3

34. Prisoner