DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

Exclusion Criteria

• •Disease state which requires destabilizing decompression
• •Axial back pain with no pain in leg, buttock, or groin
• •Baseline strength grade of 0 (total paralysis), 1 (palpable or visible contraction), or 2 (active movement, gravity,eliminated) in any lower extremity motor group as noted on Neuro Status CRF
• •Segmental kyphosis \>0° at indicated level
• •Cauda equina syndrome
• •Compression of nerve roots that causes neurogenic bowel, bladder dysfunction
• •Prior surgical procedure at involved or adjacent levels
• •Diagnosed with significant peripheral neuropathy
• •Significant vascular disease causing vascular claudication
• •Requires tx of spinal stenosis at more than 1 lumbar level
• •Significant lumbar instability, defined as \> 3mm translation on flexion/extension radiographs
• •Has \> 3mm fixed spondylolisthesis at affected level
• •BMI ≥ 40
• •Sustained vertebral or hip fracture within last year
• •Has the following (if "Yes" to any risk below, a lumbar spine DEXA Scan is required for eligibility)
• •1. Previous diagnosis of osteoporosis, osteopenia, or osteomalacia
• •2. Postmenopausal Non-Black female over age of 60 who weighs ≤ 140 lbs
• •3. Postmenopausal female who has sustained a non traumatic hip, spine or wrist fracture
• •4. Male over age of 60 who has sustained non-traumatic hip or spine fracture
• •If level of DEXA T-score is -1.0 or lower pt is excluded from study
• •Lumbar scoliosis with Cobb angle of \> 15°
• •Documented allergy to silicone, polyethylene, titanium or latex
• •Overt or active bacterial infection, local, systemic, and/or potential for bacteremia
• •Alcohol and/or drug abuser
• •Received tx with investigational therapy (device and/or pharmaceutical) within 30 days prior to entering study or such tx is planned during the 24 mos following enrollment in study
• •Suppressed immune system or has taken steroids at any dose daily for more than 1 mon within the last yr
• •Presence of active malignancy or prior history of malignancy except for basal cell carcinoma of the skin
• •History of any endocrine or metabolic disorder known to affect osteogenesis
• •Chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
• •History of autoimmune disease
• •Disease which precludes accurate clinical evaluation of safety and effectiveness of txs in this study
• •Congenital or iatrogenic posterior element insufficiency
• •Moderate to advance spondylosis or pts who demonstrate advanced degenerative changes. Such advanced degenerative changes are characterized by 1 or combination of the following a Bridging osteophytes; b Reduction or absence of motion; c Collapse of the intervertebral disc space of \> 50% of its normal ht
• •Mentally incompetent
• •Waddell Signs of Inorganic Behavior score of ≥ 3
• •Prisoner