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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: Active NA study of Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, sponsored by Empirical Spine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2026-01-16 |
| Phase | NA |
What the registry record for NCT03115983 still lists
NCT03115983 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 653-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (54% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lumbar Spinal Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03115983's enrollment target sits among peer trials
299 4th of 18 higher than 15 of 18 other Lumbar Spinal Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lumbar Spinal Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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