Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

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

NCT03115983 · View on ClinicalTrials.gov ↗

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.

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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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03115983

The ClinicalTrials.gov registry entry for NCT03115983 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Empirical Spine, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03115983 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03115983?

The interventions under investigation include: Decompression (PROCEDURE), LimiFlex (DEVICE), Fusion Instrumentation (DEVICE), Fusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03115983?

This trial is sponsored by Empirical Spine, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial