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

December 3, 2019 updated by: LDR Spine USA
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Orange County Neurosurgical Associates
      • Rancho Mirage, California, United States, 92270
        • Desert Orthopedic Center
      • Sacramento, California, United States, 95816
        • UC Davis Spine Center
      • Santa Monica, California, United States, 90403
        • The Spine Institute
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Orthopedics Northeast
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute
      • Tyler, Texas, United States, 75701
        • Texas Spine and Joint Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mobi-C and control subjects treated on the IDE/Post Approval studies, with one or two level disc replacement

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mobi-C
Prior recipient of Mobi-C Disc in IDE/Post Approval Study
Device: Mobi-C
Device for cervical intervertebral disc replacement at one or two contiguous levels
Other Names:
  • Mobi-C Cervical Disc Prosthesis
ACDF
Prior control subject in IDE/Post Approval Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NDI Score
Time Frame: 10 Years
10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success
Time Frame: 10 Year
Composite score composed of: 1) NDI improvement of at least 15 points (out of 50) from baseline; 2) No subsequent surgical intervention at the index level or levels; 3) No potentially (possibly or probably) device-related adverse event; 4) Maintenance or improvement in all components of neurologic status; and 5) No Mobi-C intraoperative changes in treatment.
10 Year
Neck Pain/Arm Pain VAS
Time Frame: 10 Year
10 Year
QOL SF-12
Time Frame: 10 Year
10 Year
Patient Satisfaction
Time Frame: 10 Year
Measured by a two questions scale that includes ranking of level of satisfaction and willingness to recommend treatment.
10 Year
Secondary surgery Rate
Time Frame: 10 Years
10 Years
Device related complications
Time Frame: 10 Years
10 Years
Device displacement or migration
Time Frame: 10 Year
Radiographic assessment of movement of device from original placement
10 Year
Range of motion
Time Frame: 10 Years
Radiographically measured angle, in degrees, between endplates of adjacent vertebrae
10 Years
Disc Height
Time Frame: 10 Years
Radiographically measured distance, in mm, from corner of superior vertebra to corresponding corner of inferior vertebra
10 Years
Heterotopic Ossification
Time Frame: 10 Years
Qualitative radiographic assessment using McAfee grading system, grades 1-4
10 Years
Adjacent Segment Degeneration
Time Frame: 10 Years
Qualitative radiographic assessment using Kellgren-Lawrence Disc Degeneration Grading, grades 0-IV
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LDR Spine USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

March 7, 2017

First Posted (ACTUAL)

March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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