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LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis
 
Region Sponsors
California - Northern
Empirical Spine, Inc.
 
Acronym KP IRB No.
LimiFlex CN-17-3062
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Individuals with lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis.
 
Purpose
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
 
Detailed Description
The LimiFlex™ Paraspinous Tension Band is a new stabilization option for patients being treated with surgical decompression for degenerative spondylolisthesis. The LimiFlex does not require pedicle screws to anchor to the spine; instead, two dynamic rods are attached by screws to pedicle-sparing straps which encircle adjacent spinous processes. The primary objective for this study is to demonstrate the safety and effectiveness of the Empirical Spine LimiFlex™ Paraspinous Tension Band when used for spinal stabilization, at one level from L1-S1, in skeletally mature patients following surgical decompression for treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis.
 
Gender Age Limit
Male & Female 25 - 80 years
 
Inclusion Criteria
  • Patients must meet ALL of the following criteria to be eligible for participation in the study:
  • Lumbar degenerative spondylolisthesis (Grade I per Meyerding classificationi), at one level from L1 to S1, with radiographic confirmation using X-ray
  • Lumbar spinal stenosis requiring decompression at up to two contiguous levels from L1 to S1, inclusive of the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI
  • Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain as evidenced by patient history
  • Persistent symptoms despite at least 3 months of conservative treatment that may include but is not limited to physical therapy, medications, and/or epidural injections
  • A pre-operative Visual Analog Scale (VAS) leg pain score of >/= 50 on a 100 mm scale
  • * Leg pain includes hip and/or buttock pain on the same side A pre-operative Oswestry Disability Index (ODI) score >/= 35 points on a 100-point scale
  • Candidate for surgical decompression at a single level or two contiguous levels with stabilization at a single level between L1 and S1
  • Posterior element anatomy is appropriate for interspinous fixation including prediction of presence of spinous processes of segment to be instrumented following decompression (investigational AND control groups) and a prediction of >50% of facet joints present following decompression (investigational group only)
  • Skeletally mature
  • Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements
 
Exclusion Criteria
  • A primary and predominate diagnosis of discogenic or facet-mediated back pain
  • Back or non-radicular leg pain of unknown etiology
  • Significant peripheral vascular disease causing vascular claudication
  • Significant peripheral neuropathy caused by conditions other than spinal stenosis
  • History of fixed or permanent neurologic deficit related to spinal cord injury
  • History of any previous surgery at the level(s) planned for treatment or at any level in the lumbosacral spine except for a discectomy or decompression (NOT including epidural injections, rhizotomy or nerve ablation)
  • Isthmic spondylolisthesis or spondylolysis at any level in the lumbar spine
  • Clinically significant compromise of vertebrae at L1 to S1 levels due to osteoporotic vertebral compression fracture or any traumatic, neoplastic, metabolic or infectious pathology or congenital abnormality
  • Spinous process fracture(s) or other posterior element fracture(s) of the segment to be instrumented
  • Degenerative lumbar scoliosis with a Cobb angle >10° at the affected motion segment
  • Symptomatic lumbar stenosis that is not amenable to a direct decompression
  • Anklyosed motion segment at the target operative level
  • Severe osteoporosis, defined as history of fragility fracture and DXA T-score < -2.5 or QCT T-score < 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed
  • Planned hip or knee replacement surgery, severe osteoarthritis or other musculoskeletal pathology of the hip or leg that could preclude reliable patient self reporting assessment scales and/or that would likely progress to surgery during study period
  • Please contact study team for more exclusion criteria.

 
Keywords and/or Specific Medical Conditions
  • Degenerative Spondylolisthesis
  • Pathological Conditions, Anatomical
  • Bone Diseases
  • Spinal Diseases
  • Constriction, Pathologic
  • Spinal Stenosis
  • Decompression
  • Spondylolisthesis
  • Fusion
  • Spondylolysis
  • Fusion Instrumentation
  • Spondylosis
  • Lumbar Spinal Stenosis
  • Surgery (Orthopedic)
  • Musculoskeletal Diseases
 
KP Clinical Facility
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Teresa Medical Center-San Jose
 
Clinical Area
  • Surgery (Orthopedic)


Principal Investigator:
Ravi Bains, MD
Contact Information:
- Isabella C Hamilton
-5108915955
-isabella.c.hamilton@kp.org
-Oakland Medical Center


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