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

Symptomatic Cervical Disc Disease Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Symptomatic Cervical Disc Disease

• NCT number: NCT04012996
• Study type: Interventional
• Source: Centinel Spine
• Contact: James Kuras
• Phone: 484.887.8873
• Email: j.kuras@centinelspine.com
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Completion date: February 2028