NCT03077516

Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: LDR Spine USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies

Detailed description

This is a prospective, multi-center, consecutive cohort study. Subjects invited to participate in this study will have completed the Mobi-C IDE study (G050212). In this study, five hundred and seventy-five subjects were randomized to either the Mobi-C prosthesis or the control treatment - conventional anterior cervical discectomy and fusion (ACDF) with anterior cervical plating. The study was randomized in a 2 to 1 ratio (two Mobi-C subjects for every one subject receiving ACDF with anterior cervical plate). The subject retention rate for Mobi-C subjects was 80.1% (1 level)-84.4% (2 level) at 7 years. As non-inferiority (1-level) and superiority (2-level) have been well established through 7 years, the design of this study will focus on the long-term outcomes of a cohort of the Mobi-C arm of the study and evaluate the durability of outcomes at 10 years. Study sites invited to participate will be those that enrolled at least 10 subjects, and also had the highest retention rates at 7 years (≥70%). All subjects at these sites will be contacted to participate in an additional 10 year follow up visit. It is estimated that up to 250 subjects will be enrolled at 9-12 study sites. Certain endpoints are better assessed in comparison to the control ACDF arm, such as adjacent segment degeneration and subsequent surgery. This study has been amended to include a subset of sites that will also enroll control subjects. Up to 3 sites and 50 subjects will be included in this control cohort.

Conditions

• Cervical Disc Disease
• Cervical Disc Degeneration

Interventions

Type	Name	Description
DEVICE	Mobi-C	Device for cervical intervertebral disc replacement at one or two contiguous levels

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2017-03-13
• Last updated: 2019-12-04

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study