Pedicle Osteotomy for Stenosis Trial (NCT03381677) | Clinical Trial Compass
SuspendedNot Applicable
Pedicle Osteotomy for Stenosis Trial
Stopped: In light of the ongoing COVID-19 pandemic and its impact on clinical trials
United States344 participantsStarted 2017-10-26
Plain-language summary
This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Is a male or female patient between 40 and 80 years of age.
✓. Has the diagnosis of degenerative spinal stenosis of the lumbar region (defined as L2-L5), defined by one or more of the following: a) narrowingof the mid-sagittal spinal canal (central stenosis), b) narrowing between the facet superior articular process (SAP) and the posterior intervertebral disc margin (lateral recess stenosis), c) narrowing of the nerve root foraminal canal(s) (foraminal stenosis) and has, at the same level, radiographic confirmation on plain lateral flexion/extension radiographs of a degenerative grade I spondylolisthesis at the same level, defined as at least 1% but not greater than 25%, offset between the posterior margins of the adjacent vertebral bodies at the index level.
✓. Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, which is worse with extended posture and relieved by flexion, as evidenced by patient history.
✓. Has pain in the leg and/or buttock that is worse with standing as compared to sitting.
✓. Has radiographic confirmation on CT or MRI of moderate or greater lumbar spinal stenosis at the index level defined as \> 25% reduction in area of the central and/or lateral recess and/or foraminal regions of the spinal canal as compared to the adjacent level.
✓. Has radiographic confirmation on CT or MRI of compression of the thecal sac and/or cauda equina and/or nerve root(s) due to hypertrophy of the facet joints and/or ligamentum flavum thickening/buckling
✓. Has undergone a 6 month or longer course of conservative therapy without sufficient relief of symptoms that has included one or more of the following interventions: physical therapy, bracing, systemic and/or injected medications.
✓. Has moderate or greater impairment on the Zurich Claudication Questionnaire (ZCQ) Physical Function scale (PF) defined as a score of 2 or greater.
Exclusion criteria
✕. Has had prior spinal surgery at any level between L1 and S1.
✕. Requires more than 2 lumbar levels of surgical decompression.
✕. Has a degenerative spondylolisthesis of greater than grade I defined as greater than 25% offset between the posterior margins of adjacent vertebral bodies on plain lateral flexion/extension radiographs or does not have a grade I degenerative spondylolisthesis, defined as 0% offset between the posterior margins of adjacent vertebral bodies on a plain lateral flexion/extension radiograph.
✕. Has more than one level of degenerative spondylolisthesis or has spondylolisthesis located at lumbar levels which are not treated with surgical decompression. Has the diagnosis of peripheral neuropathy.
✕. Has a complete motor or sensory deficit.
✕. Has a pars defect.
✕. Has facet joints at the implant level that are absent or fractured.
✕. Has lumbar scoliosis with a Cobb angle of greater than 25o.