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NCT03115983 · ClinicalTrials.gov registry record · NA

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

A NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, sponsored by Empirical Spine.

Active
Registry status
NA
Development phase
299
Enrollment target
20
Study locations

NCT03115983 is a NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis that is active but no longer recruiting, run by Empirical Spine. The registered enrollment target is 299 participants, below the 653-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT03115983, a NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, is active but no longer recruiting, sponsored by Empirical Spine.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
299 participants
Enrollment target
20
Study locations

Study 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 Studied

Lumbar Spinal Stenosis Degenerative Spondylolisthesis

Interventions

  • PROCEDURE Decompression
  • DEVICE LimiFlex
  • DEVICE Fusion Instrumentation
  • PROCEDURE Fusion

Study Locations (20)

California

  • Kaiser Permanente Division of Research - Oakland
  • Stanford University Medical Center - Redwood City
  • UC Davis Spine Center - Sacramento
  • Kaiser Permanente Roseville Clinical Trials Program - Sacramento
  • UCSF Dept of Orthopaedic Surgery - San Francisco
  • Kaiser Permanente (San Jose Medical Center) - San Jose
  • The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration - Santa Monica

Florida

  • University of Miami, Dept of Neurological Surgery - Miami
  • BioSpine - Tampa

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation - Worcester

Michigan

  • Beaumont Hospital - Royal Oak
  • Michigan Minimally Invasive Neurosurgical Institute - Waterford

Arizona

  • Sonoran Spine Research and Education Foundation - Tempe

Colorado

  • Boulder Neurological & Spine Associates - Boulder

Georgia

  • Emory University - Atlanta

Illinois

  • Rush University - Chicago

Trial Details

FieldValue
Enrollment Target 299 participants
Start Date 2017-07-17
Est. Completion 2026-01-16
Phase NA

Sponsor

Empirical Spine

1 total trials

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What the Registry Record Tells You About NCT03115983

The ClinicalTrials.gov registry entry for NCT03115983 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 653-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (54% lower). The listed sponsor is Empirical Spine, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 4 interventions - of which Decompression is the first listed.

NCT03115983 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03115983 about?

NCT03115983 is a clinical study titled "LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis". 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 (TLI...

What is the current status of trial NCT03115983?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 299 participants. The study started on 2017-07-17. Estimated completion is 2026-01-16.

What conditions does trial NCT03115983 study?

This clinical trial studies the following conditions: Lumbar Spinal Stenosis, Degenerative Spondylolisthesis.

What interventions are being tested in trial NCT03115983?

The interventions under investigation include: Decompression (PROCEDURE), LimiFlex (DEVICE), Fusion Instrumentation (DEVICE), Fusion (PROCEDURE).

Who is sponsoring clinical trial NCT03115983?

This trial is sponsored by Empirical Spine, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03115983 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.