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Completed

NCT Number: NCT03077516

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

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

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Key information

Conditions

Cervical Disc Disease Cervical Disc Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orange County Neurosurgical Associates, Laguna Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Mobi-C

Device

Device for cervical intervertebral disc replacement at one or two contiguous levels

Other names: Mobi-C Cervical Disc Prosthesis

Primary outcomes

  1. NDI Score

    Time frame: 10 Years

Secondary outcomes

  1. 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.

  2. Neck Pain/Arm Pain VAS

    Time frame: 10 Year

  3. QOL SF-12

    Time frame: 10 Year

  4. Patient Satisfaction

    Time frame: 10 Year

    Measured by a two questions scale that includes ranking of level of satisfaction and willingness to recommend treatment.

  5. Secondary surgery Rate

    Time frame: 10 Years

  6. Device related complications

    Time frame: 10 Years

  7. Device displacement or migration

    Time frame: 10 Year

    Radiographic assessment of movement of device from original placement

  8. Range of motion

    Time frame: 10 Years

    Radiographically measured angle, in degrees, between endplates of adjacent vertebrae

  9. Disc Height

    Time frame: 10 Years

    Radiographically measured distance, in mm, from corner of superior vertebra to corresponding corner of inferior vertebra

  10. Heterotopic Ossification

    Time frame: 10 Years

    Qualitative radiographic assessment using McAfee grading system, grades 1-4

  11. Adjacent Segment Degeneration

    Time frame: 10 Years

    Qualitative radiographic assessment using Kellgren-Lawrence Disc Degeneration Grading, grades 0-IV

Sponsors and collaborators

Lead sponsor

LDR Spine USA

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2017
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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