NCT04520776

A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease

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 a Single Level

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• 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). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-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: 2026-02-01
• Completion: 2026-02-01
• First posted: 2020-08-20
• Last updated: 2024-05-29

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study