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About
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.
Full description
This pivotal clinical trial is being conducted to evaluate the DIAM Spinal Stabilization System for the treatment of single-level degenerative lumbar spinal stenosis from L2 to L5. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System. And following a decompression procedure, the device will be implanted using a posterior surgical approach. Patients in the control group will receive a lumbar decompression.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Leg pain score must be ≥ back pain score
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)
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
Primary purpose
Allocation
Interventional model
Masking
32 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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