NCT03077516

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

November 28, 2016

Last Update Submit

December 3, 2019

Conditions

Cervical Disc DiseaseCervical Disc Degeneration

Outcome Measures

Primary Outcomes (1)

  • NDI Score

    10 Years

Secondary Outcomes (11)

  • Overall Success

    10 Year

  • Neck Pain/Arm Pain VAS

    10 Year

  • QOL SF-12

    10 Year

  • Patient Satisfaction

    10 Year

  • Secondary surgery Rate

    10 Years

  • +6 more secondary outcomes

Study Arms (2)

Mobi-C

Prior recipient of Mobi-C Disc in IDE/Post Approval Study

Device: Mobi-C

ACDF

Prior control subject in IDE/Post Approval Study

Interventions

Mobi-CDEVICE

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

Also known as: Mobi-C Cervical Disc Prosthesis
Mobi-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Orange County Neurosurgical Associates

Laguna Hills, California, 92653, United States

Location

Desert Orthopedic Center

Rancho Mirage, California, 92270, United States

Location

UC Davis Spine Center

Sacramento, California, 95816, United States

Location

The Spine Institute

Santa Monica, California, 90403, United States

Location

Orthopedics Northeast

Fort Wayne, Indiana, 46825, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Texas Spine and Joint Hospital

Tyler, Texas, 75701, United States

Location

Related Publications (4)

  • Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.

    PMID: 27015130BACKGROUND

  • Hisey MS, Zigler JE, Jackson R, Nunley PD, Bae HW, Kim KD, Ohnmeiss DD. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.

    PMID: 27162712BACKGROUND

  • Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016 May;24(5):734-45. doi: 10.3171/2015.8.SPINE15219. Epub 2016 Jan 22.

    PMID: 26799118BACKGROUND

  • Ament JD, Yang Z, Nunley P, Stone MB, Lee D, Kim KD. Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up. Neurosurgery. 2016 Jul;79(1):135-45. doi: 10.1227/NEU.0000000000001208.

    PMID: 26855020BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

March 13, 2017

Study Start

November 1, 2016

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(8)