Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease
Public ClinicalTrials.gov record NCT00478088. 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 Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
Study identification
- NCT ID
- NCT00478088
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 488 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 60 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
- Sep 2006 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Mar 2012 (Actual)
- Last update posted
- Dec 19, 2025
2006 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| San Diego Center for Spinal Disorders | La Jolla | California | 92037 | — |
| Diagnostic and Interventional Surgical Center | Marina del Rey | California | 90245 | — |
| The Spine Institute | Santa Monica | California | 90404 | — |
| Spine Colorado / Durango Orthopedic Associates | Durango | Colorado | 81301 | — |
| Rocky Mountain Spine Arthroplasty (RMA Ortho) | Loveland | Colorado | 80538 | — |
| Florida Spine Specialists | Fort Lauderdale | Florida | 33308 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| Lyerly Baptist | Jacksonville | Florida | 32207 | — |
| Optim Healthcare | Savannah | Georgia | 31405 | — |
| OAD Orthopaedics | Warrenville | Illinois | 60555 | — |
| OrthoIndy | Indianapolis | Indiana | 46278 | — |
| Spine Midwest, Inc | Jefferson City | Missouri | 65101 | — |
| Western Regional Spine Center for Brain and Spine Surgery | Las Vegas | Nevada | 89109 | — |
| Coastal Spine | Mount Laurel | New Jersey | 08054 | — |
| Capital Neurosurgery | Raleigh | North Carolina | 27609 | — |
| Center for Advanced Orthopaedics/Adena Health Pavillon | Chillicothe | Ohio | 45601 | — |
| Neurological Associates | Columbus | Ohio | 43221 | — |
| Central Ohio Neurological Surgeons | Westerville | Ohio | 43081 | — |
| Orthopedic Spine Associates | Eugene | Oregon | 97401 | — |
| Southern Oregon Orthopedics | Medford | Oregon | 97504 | — |
| Central Texas Spine Institute | Austin | Texas | 78731 | — |
| Salt Lake Orthopaedic Clinic | Salt Lake City | Utah | 82124 | — |
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 NCT00478088, 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 Dec 19, 2025 · 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 NCT00478088 live on ClinicalTrials.gov.