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Active, not recruiting Not applicable Interventional

A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

ClinicalTrials.gov ID: NCT04564885

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:13 AM EDT

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
Lead sponsor
Spineart USA
Industry
Enrollment
300 participants

Conditions and interventions

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 2, 2021 (Actual)
Primary completion
Apr 2025 (Estimated)
Completion
Apr 2030 (Estimated)
Last update posted
Mar 8, 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 8, 2024 · 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 NCT04564885 live on ClinicalTrials.gov.

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