NCT03115983 - LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis | Biotech Hunter

Enrollment

299

Participants

Timeline

Start Date

July 17, 2017

Primary Completion Date

December 30, 2025

Study Completion Date

January 16, 2026

Conditions

Degenerative SpondylolisthesisLumbar Spinal Stenosis

Interventions

DEVICE

LimiFlex

LimiFlex implantation at a single level after surgical decompression.

DEVICE

Fusion Instrumentation

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).

PROCEDURE

Decompression

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

PROCEDURE

Fusion

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

Trial Locations (28)

10022

Hospital for Special Surgery, New York

13057

SUNY Upstate Medical University, Syracuse

13760

UHS Neurosurgery (Binghamton), Binghamton

19106

University of Pennsylvania Hospital, Philadelphia

22908

University of Virginia Orthopaedic Surgery, Charlottesville

30329

Emory University, Atlanta

33136

University of Miami, Dept of Neurological Surgery, Miami

33607

BioSpine, Tampa

40202

Norton Leatherman Spine Center, Louisville

43210

The Ohio State University, Columbus

46032

Indiana Spine Group, Carmel

48073

Beaumont Hospital, Royal Oak

48327

Michigan Minimally Invasive Neurosurgical Institute, Waterford

60612

Rush University, Chicago

63110

Washington University School of Medicine, St Louis

75093

Texas Back Institue, Clincal Research, LLC-Plano, Plano

80303

Boulder Neurological & Spine Associates, Boulder

85281

Sonoran Spine Research and Education Foundation, Tempe

90403

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

94063

Stanford University Medical Center, Redwood City

94143

UCSF Dept of Orthopaedic Surgery, San Francisco

94611

Kaiser Permanente Division of Research, Oakland

95119

Kaiser Permanente (San Jose Medical Center), San Jose

95816

UC Davis Spine Center, Sacramento

95825

Kaiser Permanente Roseville Clinical Trials Program, Sacramento

98122

Swedish Medical Center, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

01605

University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation, Worcester