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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

Cervical Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04564885
Study type Interventional
Source Spineart USA
Contact
Status Active, not recruiting
Phase N/A
Start date March 2, 2021
Completion date April 2030
View Details
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