NCT04012996

2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Centinel Spine · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

Detailed description

The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.

Conditions

• Symptomatic Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	prodisc C SK and/or Vivo	Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
DEVICE	Mobi-C Cervical Disc	Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

Timeline

• Start date: 2019-08-05
• Primary completion: 2025-08-31
• Completion: 2028-05-13
• First posted: 2019-07-09
• Last updated: 2025-07-30

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study