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

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ClinicalTrials.gov Identifier: NCT03077516
Recruitment Status : Enrolling by invitation
First Posted : March 13, 2017
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA

Brief 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

Condition or disease Intervention/treatment
Cervical Disc Disease Cervical Disc Degeneration Device: Mobi-C

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
Actual Study Start Date : November 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

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 Name: Mobi-C Cervical Disc Prosthesis

ACDF
Prior control subject in IDE/Post Approval Study



Primary Outcome Measures :
  1. NDI Score [ Time Frame: 10 Years ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077516


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

Publications:
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Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT03077516     History of Changes
Other Study ID Numbers: MC-100
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action