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A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis

NCT No.: NCT03115983

Study Type: INTERVENTIONAL

Phase: n/a

Region: California - Northern

Acronym: LimiFlex

Official Title

A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis 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.

Sex

Male & Female

Age Limit

25 - 80 years

Eligibility Criteria

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

  • Bone Diseases
  • Constriction, Pathologic
  • Decompression
  • Degenerative Spondylolisthesis
  • Fusion
  • Fusion Instrumentation
  • LSS17001
  • Lumbar Spinal Stenosis
  • Musculoskeletal Diseases
  • Pathological Conditions, Anatomical
  • Spinal Diseases
  • Spinal Stenosis
  • Spondylolisthesis
  • Spondylolysis
  • Spondylosis
  • Surgery (Orthopedic)

Sponsors

  • Empirical Spine, Inc.

Principal Investigator

Ravi Bains , MD 

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- Oakland Medical Center

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