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

Cervical Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077516
• Other study ID #: MC-100
• Status: Completed
• Start date: November 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2019
• Source: LDR Spine USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Cervical Disc Disease
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Diseases

Intervention

Device:
• Mobi-C
Device for cervical intervertebral disc replacement at one or two contiguous levels

Locations

Country	Name	City	State
United States	Orthopedics Northeast	Fort Wayne	Indiana
United States	Orange County Neurosurgical Associates	Laguna Hills	California
United States	Texas Back Institute	Plano	Texas
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	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Texas Spine and Joint Hospital	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LDR Spine USA

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Neurosurg Spine. 2016 Aug;25(2):280. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NDI Score		10 Years
Secondary	Overall Success	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
Secondary	Neck Pain/Arm Pain VAS		10 Year
Secondary	QOL SF-12		10 Year
Secondary	Patient Satisfaction	Measured by a two questions scale that includes ranking of level of satisfaction and willingness to recommend treatment.	10 Year
Secondary	Secondary surgery Rate		10 Years
Secondary	Device related complications		10 Years
Secondary	Device displacement or migration	Radiographic assessment of movement of device from original placement	10 Year
Secondary	Range of motion	Radiographically measured angle, in degrees, between endplates of adjacent vertebrae	10 Years
Secondary	Disc Height	Radiographically measured distance, in mm, from corner of superior vertebra to corresponding corner of inferior vertebra	10 Years
Secondary	Heterotopic Ossification	Qualitative radiographic assessment using McAfee grading system, grades 1-4	10 Years
Secondary	Adjacent Segment Degeneration	Qualitative radiographic assessment using Kellgren-Lawrence Disc Degeneration Grading, grades 0-IV	10 Years