Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care

Exclusion Criteria

• •A patient meeting any of the following criteria is to be excluded from this clinical trial:
• •1. Has disc height loss \> 67% at the involved level, compared to the next adjacent (superior or inferior, whichever has greater disc height) spinal level
• •2. Has Arachnoiditis.
• •3. Has a primary diagnosis of a spinal disorder other than degenerative disc disease at the involved level.
• •4. Requires treatment of degenerative disc disease at more than one lumbar level.
• •5. Has had all of the following nonoperative treatments (prescribed medications, active physical therapy, spinal injections, and patient education) within the past 6 weeks.
• •6. Has a sequestered herniated nucleus pulposus.
• •7. Has had any previous surgery at the involved or adjacent spinal levels (including procedures such as rhizotomy).
• •8. Has received any intradiskal ablation therapy, such as IDET.
• •9. Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta).
• •10. Has back pain (with or without leg, buttock, or groin pain) that is not alleviated in any spinal position.
• •11. Has a motor deficit of the lower extremity.
• •12. Has cauda equina syndrome.
• •13. Has compression of nerve roots with neurogenic bowel (fecal incontinence) or bladder (urinary retention or incontinence) dysfunction.
• •14. Has been previously diagnosed with clinically significant peripheral neuropathy.
• •15. Has significant vascular disease causing vascular claudication.
• •16. Has a medical contraindication that prevents the patient from receiving spinal injections (i.e., allergy to contrast media used to aid in placement of the needle in the epidural space).
• •17. Has ventral spondylolisthesis with more than 2 mm of translation at the involved level.
• •18. Has evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst.
• •19. Has lumbar scoliosis with a Cobb angle of greater than 15°.
• •20. Has lumbar kyphosis or flat back syndrome.
• •21. Has sustained a hip fracture within the last year.
• •22. Has any of the following (if "Yes" to any of the below risk factors, a lumbar spine DEXA Scan will be required to determine eligibility.):
• •1. Previous diagnosis of osteoporosis, osteopenia, or osteomalacia.
• •2. Postmenopausal Non-Black female over 60 years of age who weighs less than 140 pounds.
• •3. Postmenopausal female who has sustained a non-traumatic hip, spine or wrist fracture.
• •4. Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
• •If the level of DEXA T-score is -1.0 or lower (i.e., -1.5, -2.0, etc.), the patient is excluded from the study.
• •23. Has obesity defined by BMI greater than or equal to 40. (Refer to the BMI Table provided in the CIP.)
• •24. Has a documented allergy to silicone, polyethylene, titanium, or latex.
• •25. Has overt or active bacterial infection, either local or systemic, and/or potential for bacteremia.
• •26. Has a suppressed immune system or has taken steroids at any dose daily for more than one month within the last year (excluding low dose inhalers for the treatment of asthma).
• •27. Has a history of autoimmune disease.
• •28. Has presence of active malignancy or prior history of malignancy within the last 5 years (except for basal cell carcinoma of the skin).
• •29. Has presence or prior history of a spinal malignancy.
• •30. Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease.
• •31. Has any disease (e.g., neuromuscular disease) that would preclude accurate clinical evaluation of the safety and effectiveness of the treatment regimens in this study.
• •32. Has received treatment with an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment in the study.
• •33. Has an implantable metal device (e.g., stimulator, pacemaker) and is unable to have an MRI.
• •34. Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.
• •35. Is mentally incompetent. If questionable, obtain psychiatric consult.
• •36. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
• •37. Is a prisoner.