A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels
Public ClinicalTrials.gov record NCT04564885. 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 Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous Levels
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
Study identification
- NCT ID
- NCT04564885
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 69 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
- Mar 1, 2021
- Primary completion
- Mar 31, 2025
- Completion
- Mar 31, 2030
- Last update posted
- Mar 7, 2024
2021 – 2030
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MORE Foundation | Phoenix | Arizona | 85023 | — |
| Desert Institute for Spine Care | Scottsdale | Arizona | 85258 | — |
| BEEL Medical | Laguna Hills | California | 92653 | — |
| Orange County Neurosurgical Associates | Mission Viejo | California | 92691 | — |
| UCI Health | Orange | California | 92868 | — |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | — |
| The Spine Institute, Center for Spine Restoration | Santa Monica | California | 90403 | — |
| Institute for Neuro Innovation | West Hills | California | 91307 | — |
| Vail-Summit Orthopaedics and Neurosurgery | Vail | Colorado | 81657 | — |
| Hartford Health CT Orthopaedics | Hamden | Connecticut | 06518 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20057 | — |
| Legacy Brain & Spine | Atlanta | Georgia | 30339 | — |
| Midwest Orthopedics at Rush | Chicago | Illinois | 60612 | — |
| NorthShore | Evanston | Illinois | 60201 | — |
| Indiana Spine Group | Carmel | Indiana | 46032 | — |
| Ortho NorthEast | Fort Wayne | Indiana | 46825 | — |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | — |
| Spine Institute of Louisiana Foundation | Shreveport | Louisiana | 71101 | — |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | — |
| The Ohio State University - Dept of Orthadedics | Columbus | Ohio | 43210 | — |
| Oregon Spine Care | Tualatin | Oregon | 97062 | — |
| Neurosurgical Associates of Lancaster | Lancaster | Pennsylvania | 17601 | — |
| Center for Sports Medicine & Orthopedics | Chattanooga | Tennessee | 37404 | — |
| St. David's Healthcare | Austin | Texas | 78705 | — |
| The Disc Replacement Center | Salt Lake City | Utah | 84088 | — |
| Swedish Neuroscience, Swedish Spine Institute | 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 NCT04564885, 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 Mar 7, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04564885 live on ClinicalTrials.gov.