LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
Public ClinicalTrials.gov record NCT03115983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis With Spinal Stenosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03115983
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 299 participants
Conditions and interventions
Interventions
- LimiFlex Device
- Fusion Instrumentation Device
- Decompression Procedure
- Fusion Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 25 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 17, 2017 (Actual)
- Primary completion
- Dec 30, 2025 (Estimated)
- Completion
- Jan 16, 2026 (Estimated)
- Last update posted
- Aug 7, 2025
2017 – 2026
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sonoran Spine Research and Education Foundation | Tempe | Arizona | 85281 | — |
| Kaiser Permanente Division of Research | Oakland | California | 94611 | — |
| Stanford University Medical Center | Redwood City | California | 94063 | — |
| UC Davis Spine Center | Sacramento | California | 95816 | — |
| Kaiser Permanente Roseville Clinical Trials Program | Sacramento | California | 95825 | — |
| UCSF Dept of Orthopaedic Surgery | San Francisco | California | 94143 | — |
| Kaiser Permanente (San Jose Medical Center) | San Jose | California | 95119 | — |
| The Spine Institute, Center for Spinal Restoration and Foundation for Spinal Restoration | Santa Monica | California | 90403 | — |
| Boulder Neurological & Spine Associates | Boulder | Colorado | 80303 | — |
| University of Miami, Dept of Neurological Surgery | Miami | Florida | 33136 | — |
| BioSpine | Tampa | Florida | 33607 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Norton Leatherman Spine Center | Louisville | Kentucky | 40202 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Massachusetts, Dept of Orthopedics and Physical Rehabilitation | Worcester | Massachusetts | 01605 | — |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Michigan Minimally Invasive Neurosurgical Institute | Waterford | Michigan | 48327 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| UHS Neurosurgery (Binghamton) | Binghamton | New York | 13760 | — |
| Hospital for Special Surgery | New York | New York | 10022 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13057 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | — |
| Texas Back Institue, Clincal Research, LLC-Plano | Plano | Texas | 75093 | — |
| University of Virginia Orthopaedic Surgery | Charlottesville | Virginia | 22908 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03115983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03115983 live on ClinicalTrials.gov.