A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Public ClinicalTrials.gov record NCT00401518. 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
The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.
Study identification
- NCT ID
- NCT00401518
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 390 participants
Conditions and interventions
Conditions
Interventions
- Non-randomized ACADIA® Facet Replacement System Device
- Randomized ACADIA® Facet Replacement System Device
- Randomized Instrumented posterolateral fusion (PLF) Device
Device
Eligibility (public fields only)
- Age range
- 21 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- Aug 2017 (Actual)
- Completion
- Oct 2017 (Actual)
- Last update posted
- Sep 10, 2020
2006 – 2017
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spine Group Beverly Hills | Beverly Hills | California | 90211 | — |
| Cedars-Sinai Spine Center | Los Angeles | California | 90048 | — |
| Desert Orthopaedic Center | Rancho Mirage | California | 92270 | — |
| Boulder Neurosurgical & Spine Associates | Boulder | Colorado | 80303 | — |
| Spine Colorado | Durango | Colorado | 81301 | — |
| Rocky Mountain Associates (RMA) in Orthopedic Medicine | Loveland | Colorado | 80538 | — |
| Florida Spine Institute | Clearwater | Florida | 33765 | — |
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | — |
| Neurological Institute of Savannah and Center for Spine | Savannah | Georgia | 31405 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Fort Wayne Orthopaedics | Fort Wayne | Indiana | 46804 | — |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | — |
| Rubin Institute for Advanced Orthopaedics | Owings Mills | Maryland | 21117 | — |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01605 | — |
| Spine Midwest, Inc. | Jefferson City | Missouri | 65101 | — |
| Springfield Neurological & Spine Institute | Springfield | Missouri | 65804 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Carolina Neurosurgery and Spine Associates, P.C. | Charlotte | North Carolina | 28204 | — |
| OrthoCarolina Spine Center | Charlotte | North Carolina | 28207 | — |
| Riverhills Healthcare | Cincinnati | Ohio | 45242 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Charleston Brain & Spine | Charleston | South Carolina | 29406 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Neuro-Spine Solutions | Bristol | Tennessee | 37620 | — |
| The Center for Sports Medicine & Orthopedics | Chattanooga | Tennessee | 37404 | — |
| Central Texas Spine Institute | Austin | Texas | 78731 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00401518, 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 Sep 10, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00401518 live on ClinicalTrials.gov.