The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
Degenerative spine disease is a normal part of the aging process and can cause pain and significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks and/or lower extremities that is worsened with standing and walking. For patients that do not respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often added to prevent progression of the instability that may accompany the removal of bony elements as part of the decompression. While decompression and fusion have been shown to significantly improve patient outcomes, when compared to decompression alone, fusion has been associated with several comorbidities such as adjacent level degeneration and pseudoarthrosis. The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery. Patients meeting all of the entry criteria will be randomized (2:1) to receive either the TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years and the composite primary endpoint will be assessed at 2 years following index surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
Fusion with placement of interbody cage and posterolateral instrumentation
Adventist Health Glendale
Glendale, California, United States
Cedars Sinai
Los Angeles, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Eisenhower Desert Orthopedic Center
Palm Desert, California, United States
St. Mary's Medical Center, Spine Center
San Francisco, California, United States
Improvement in Oswestry Disability Index (ODI)
Time frame: 24 months
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
Time frame: 24 months
No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
Time frame: 24 months
No subsequent surgical intervention
Time frame: 24 months
Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
Time frame: 24 months
Absence of any major device related adverse event
Time frame: 24 months
Greater range-of-motion through flexion-extension
Time frame: 24 months
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
Time frame: 24 months
Reduction in physical component score on SF-12
Time frame: 24 months
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University of Colorado
Aurora, Colorado, United States
Boulder Neurosurgical & Spine Associates
Boulder, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Sibley Hospital/Johns Hopkins
Washington D.C., District of Columbia, United States
Florida Spine Institute
Clearwater, Florida, United States
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