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

Not Applicable
Active, not recruiting
Conditions
Cervical Disc Disease
Registration Number
NCT04564885
Lead Sponsor
Spineart USA
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Procedure or device related serious adverse events24 month follow-up visit

No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee

Neck Disability Index24 month follow-up visit

at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale

No secondary surgical intervention per protocol definition24 month follow-up visit

any revision, removal, re-operation, or supplemental fixation at the index level

Maintenance or improvement in neurological status24 month follow-up visit

pre and post-op neurological examination to determine maintenance or improvement

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (26)

MORE Foundation

🇺🇸

Phoenix, Arizona, United States

Desert Institute for Spine Care

🇺🇸

Scottsdale, Arizona, United States

BEEL Medical

🇺🇸

Laguna Hills, California, United States

Orange County Neurosurgical Associates

🇺🇸

Mission Viejo, California, United States

UCI Health

🇺🇸

Orange, California, United States

Eisenhower Medical Center

🇺🇸

Rancho Mirage, California, United States

The Spine Institute, Center for Spine Restoration

🇺🇸

Santa Monica, California, United States

Institute for Neuro Innovation

🇺🇸

West Hills, California, United States

Vail-Summit Orthopaedics and Neurosurgery

🇺🇸

Vail, Colorado, United States

Hartford Health CT Orthopaedics

🇺🇸

Hamden, Connecticut, United States

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MORE Foundation
🇺🇸Phoenix, Arizona, United States
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