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

NCT03115983 | Active Not Recruiting DMC FDA Device

• 1 other identifier: LSS17001
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

Degenerative Spondylolisthesis; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Composite Clinical Success

  Individual success for patients in the investigational LimiFlex or control fusion arm is assessed with Composite Clinical Success (CCS) criteria. To be considered a success, a subject must demonstrate all of the following: * 15 point improvement in Oswestry Disability Index (100 point scale) * Absence of a new or worsening, persistent neurological deficit * Absence of additional surgical intervention * Absence of device integrity failures

  24 Months

Secondary Outcomes (16)

• Oswestry Disability Index (ODI)

  Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

• Neurological Status

  Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

• Additional surgical interventions

  Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

• Absence of device integrity failures defined as device breakage, device separation or disassembly, or device dislocation

  Both groups: 6 wks, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo, 48 mo, 60 mo

• Estimated blood loss

  Procedure

Study Arms (2)

LimiFlex

EXPERIMENTAL

Posterior dynamic stabilization with the LimiFlex Paraspinous Tension Band

Device: LimiFlex; Procedure: Decompression

Fusion

ACTIVE COMPARATOR

Transforaminal lumbar interbody fusion with concomitant posterolateral fusion with pedicle screw instrumentation

Device: Fusion Instrumentation; Procedure: Decompression; Procedure: Fusion

Interventions

LimiFlex DEVICE

LimiFlex implantation at a single level after surgical decompression.

Also known as: LimiFlex Paraspinous Tension Band

LimiFlex

Fusion Instrumentation DEVICE

Titanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).

Fusion

Decompression PROCEDURE

Surgical decompression at one or two contiguous levels from L1 to S1.

Fusion; LimiFlex

Fusion PROCEDURE

Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.

Fusion

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lumbar degenerative spondylolisthesis (Grade I per Meyerding classification), at one level from L1 to S1, with radiographic confirmation using X-ray;
• a. Grade I spondylolisthesis per Meyerding classification includes up to 25% anterior translation of a vertebra relative to the superior endplate of the subjacent vertebra at the index level. A patient is considered to have spondylolisthesis with a minimum 10% anterolisthesis at the affected level in a lateral x-ray image.
• 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;
• a. At the index level, lumbar spinal stenosis is at least moderate lumbar canal stenosis, defined as more than 25% reduction of the cross-sectional area compared with the next adjacent normal level, with nerve root crowding compared with the normal level, as determined by the investigator on CT Scan or MRI.
• Neurogenic claudication or radiculopathy 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 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; and
• Patient is willing to provide Informed Consent for study participation.

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;

Sponsors & Collaborators

• Empirical Spine, Inc.: lead
• Biomedical Statistical Consulting: collaborator
• Medical Metrics Diagnostics, Inc: collaborator
• MCRA: collaborator

Study Sites (28)

Sonoran Spine Research and Education Foundation

Tempe, Arizona, 85281, United States

Location

Kaiser Permanente Division of Research

Oakland, California, 94611, United States

Location

Stanford University Medical Center

Redwood City, California, 94063, United States

Location

UC Davis Spine Center

Sacramento, California, 95816, United States

Location

Kaiser Permanente Roseville Clinical Trials Program

Sacramento, California, 95825, United States

Location

UCSF Dept of Orthopaedic Surgery

San Francisco, California, 94143, United States

Location

Kaiser Permanente (San Jose Medical Center)

San Jose, California, 95119, United States

Location

The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration

Santa Monica, California, 90403, United States

Location

Boulder Neurological & Spine Associates

Boulder, Colorado, 80303, United States

Location

University of Miami, Dept of Neurological Surgery

Miami, Florida, 33136, United States

Location

BioSpine

Tampa, Florida, 33607, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation

Worcester, Massachusetts, 01605, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Michigan Minimally Invasive Neurosurgical Institute

Waterford, Michigan, 48327, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

UHS Neurosurgery (Binghamton)

Binghamton, New York, 13760, United States

Location

Hospital for Special Surgery

New York, New York, 10022, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13057, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Texas Back Institue, Clincal Research, LLC-Plano

Plano, Texas, 75093, United States

Location

University of Virginia Orthopaedic Surgery

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Maislin G, Keenan BT, Alamin TF, Fielding LC, Scherman A, Hachadoorian R, Pierre C, Sasso RC, Lavelle WF, Chapman J. Are Randomized Trials Better? Comparison of Baseline Covariate Balance of a Propensity Score-Balanced Lumbar Spine IDE Trial and Comparable RCTs. Global Spine J. 2025 Jul;15(6):2923-2930. doi: 10.1177/21925682251316287. Epub 2025 Jan 27.

  PMID: 39868633 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Decompression; Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena

Study Officials

• Rick Sasso, MD

  Indiana Spine Group

  PRINCIPAL INVESTIGATOR

• William C Welch, MD

  Pennsylvania Hospital Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, prospective, concurrently controlled, non-blinded study. Balance between groups will be achieved through sub classification using propensity scores. Prospective patient sample supplemented with retrospective and/or historical control subjects.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 14, 2017
• Study Start: July 17, 2017
• Primary Completion: December 30, 2025
• Study Completion: January 16, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)