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

Completed

Conditions studied: Cervical Disc Disease, Cervical Disc Degeneration

In brief

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

Key facts

Study ID

NCT03077516

Run by

LDR Spine USA

People needed

216

Starts

2016-11-01

Expected to finish

2019-10-31

Last updated by the study team

2019-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior enrollment in LDR-001 Pivotal Study (IDE G050212);
• Written informed consent provided by subject or subject's legally authorized representative

You may not qualify if…

• Documented withdrawal of consent from prior Mobi-C study;
• Documented non-compliance (including unwillingness to return to the site for follow-up visits)
• Reported pregnancy at time of enrollment, or with plans to become pregnant prior to completing study X-Rays

Where it is running

• Orange County Neurosurgical Associates — Laguna Hills, California, United States
• Desert Orthopedic Center — Rancho Mirage, California, United States
• UC Davis Spine Center — Sacramento, California, United States
• The Spine Institute — Santa Monica, California, United States
• Orthopedics Northeast — Fort Wayne, Indiana, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Texas Back Institute — Plano, Texas, United States
• Texas Spine and Joint Hospital — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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