A Pivotal Study of the Premia Spine TOPS™ System
Public ClinicalTrials.gov record NCT03012776. 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 Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
Study identification
- NCT ID
- NCT03012776
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 305 participants
Conditions and interventions
Interventions
Device · Procedure
Eligibility (public fields only)
- Age range
- 35 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
- Jun 27, 2022 (Actual)
- Completion
- Jun 14, 2023 (Actual)
- Last update posted
- Jun 17, 2024
2017 – 2023
United States locations
- U.S. sites
- 36
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Adventist Health Glendale | Glendale | California | 91206 | — |
| Cedars Sinai | Los Angeles | California | 90048 | — |
| University of California - Irvine Medical Center | Orange | California | 92868 | — |
| Eisenhower Desert Orthopedic Center | Palm Desert | California | 92270 | — |
| St. Mary's Medical Center, Spine Center | San Francisco | California | 94117 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Boulder Neurosurgical & Spine Associates | Boulder | Colorado | 80303 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Sibley Hospital/Johns Hopkins | Washington D.C. | District of Columbia | 20016 | — |
| Florida Spine Institute | Clearwater | Florida | 33765 | — |
| St. Vincent's Spine & Brain Institute | Jacksonville | Florida | 32216 | — |
| Physicians Regional Medical Center | Naples | Florida | 34119 | — |
| Kennedy White Orthopedic Center | Sarasota | Florida | 34232 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31405 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Goodman Campbell Brain & Spine | Carmel | Indiana | 46032 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Bronson Neuroscience Center | Kalamazoo | Michigan | 49007 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| Carolina Neurosurgery & Spine Associates, P.A. | Charlotte | North Carolina | 28204 | — |
| Univ. of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Southern Oregon Orthopedics | Medford | Oregon | 97504 | — |
| Orthopedic Institute of Pennsylvania | Harrisburg | Pennsylvania | 17011 | — |
| UPENN Health Systems Department of Neurosurgery | Philadelphia | Pennsylvania | 19106 | — |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | — |
| Orthopaedic Associates | Bellaire | Texas | 77401 | — |
| Texas Back Institute | Plano | Texas | 75093 | — |
| Baylor Scott & White | Temple | Texas | 76508 | — |
| Neurosurgical Associates, P.C. | Richmond | Virginia | 23229 | — |
| Marshall University | Huntington | West Virginia | 25755 | — |
| Wisconsin Bone and Joint S.C. | Milwaukee | Wisconsin | 53212 | — |
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 NCT03012776, 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 Jun 17, 2024 · 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 NCT03012776 live on ClinicalTrials.gov.