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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 classification), at one level from L1 to S1, with radiographic confirmation using X-ray

Lumbar spinal stenosis, at the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI (at the index level, lumbar spinal stenosis is at least moderate lumbar canal stenosis, as determined by the investigator on CT Scan 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 6 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 leg pain score of =50 on a 100 mm scale

A pre-operative Oswestry Disability Index score =35 points on a 100-point scale

Candidate for surgical decompression and stabilization at only one level between L1-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)

25-80 years of age and 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 neurological deficit related to spinal cord injury

History of any previous surgery at any level in the lumbosacral spine except for a discectomy or decompression (NOT including epidural injections)

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 < -2.5. History of a fragility fracture requires that a DXA scan or QCT scan is completed

Planned hip or knee replacement surgery

Documented allergy to titanium or polyethylene

Active local or systemic infection

Receiving immunosuppressive or long-term steroid therapy

Known history of bone metabolic disorder

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

Oakland Medical Center

Roseville Medical Center

Santa Teresa Medical Center-San Jose

Clinical Area

Surgery (Orthopedic)

Surgery (Orthopedic)

Principal Investigator:

Ravi Bains, MD

Ravi Bains, MD

Contact Information:

	-	Amena Wardak
	-	amena.wardak@kp.org
	-	Oakland Medical Center

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