NCT04564885

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Spineart USA · Industry
• Sex: All
• Age: 22 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	BAGUERA®C Cervical Disc Prosthesis	surgery
DEVICE	Mobi-C Cervical Disc	surgery

Timeline

• Start date: 2021-03-02
• Primary completion: 2025-04-01
• Completion: 2030-04-01
• First posted: 2020-09-25
• Last updated: 2024-03-08

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated device study