LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

Running, not enrolling · Not applicable

Conditions studied: Degenerative Spondylolisthesis, Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT03115983

Run by

Empirical Spine, Inc.

People needed

299

Starts

2017-07-17

Expected to finish

2026-01-16

Last updated by the study team

2025-08-07

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A primary and predominate diagnosis of discogenic back pain;
• A primary and predominate diagnosis of 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;
• History of any previous surgery* at the level planned for treatment;
• previous surgery includes spinal stimulator placement but does NOT include epidural injections, rhizotomy or nerve ablation.
• Isthmic spondylolisthesis or spondylolysis (pars fracture) 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 that would preclude secure fixation of the LimiFlex Device to the spinous process;
• Spinous process insufficiency or deformity that would preclude secure fixation of the LimiFlex Device to the spinous process including spinous process length <10 mm from lamina to dorsal tip or other significant deformity due to trauma, or congenital abnormality such as spina bifida occulta at the planned instrumented level that would preclude secure fixation of the LimiFlex Device to the spinous process;
• The estimated distance between the LimiFlex Device strap attachment points (midpoint of the cranial edge of the cranial spinous process and the midpoint of the caudal edge of the caudal spinous process) is <30mm on pre-operative lateral standing radiographs at 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;
• Documented allergy to titanium or polyethylene;
• Active local or systemic infection;
• Receiving immunosuppressive or long-term steroid therapy;
• Known history of bone metabolic disorder, including Paget's disease, hyperparathyroidism, renal osteodystrophy, and osteomalacia;
• Disease or condition that would preclude accurate clinical evaluation of the safety and effectiveness of the study treatment or any significant medical conditions which would place the patient at excessive risk for surgery, such as:
• severe rheumatoid arthritis or other severe autoimmune disease

Where it is running

• Sonoran Spine Research and Education Foundation — Tempe, Arizona, United States
• Kaiser Permanente Division of Research — Oakland, California, United States
• Stanford University Medical Center — Redwood City, California, United States
• UC Davis Spine Center — Sacramento, California, United States
• Kaiser Permanente Roseville Clinical Trials Program — Sacramento, California, United States
• UCSF Dept of Orthopaedic Surgery — San Francisco, California, United States
• Kaiser Permanente (San Jose Medical Center) — San Jose, California, United States
• The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration — Santa Monica, California, United States
• Boulder Neurological & Spine Associates — Boulder, Colorado, United States
• University of Miami, Dept of Neurological Surgery — Miami, Florida, United States
• BioSpine — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University — Chicago, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Norton Leatherman Spine Center — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation — Worcester, Massachusetts, United States
• Beaumont Hospital — Royal Oak, Michigan, United States
• Michigan Minimally Invasive Neurosurgical Institute — Waterford, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• UHS Neurosurgery (Binghamton) — Binghamton, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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