Clinical trial NCT03077516: Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
Official title: Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Disc Disease
Cervical Disc Degeneration
Lead sponsor: LDR Spine USA
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: NDI Score
timeFrame: 10 Years
Secondary outcomes:
measure: Overall Success
timeFrame: 10 Year
measure: Neck Pain/Arm Pain VAS
timeFrame: 10 Year
measure: QOL SF-12
timeFrame: 10 Year
measure: Patient Satisfaction
timeFrame: 10 Year
measure: Secondary surgery Rate
timeFrame: 10 Years
measure: Device related complications
timeFrame: 10 Years
measure: Device displacement or migration
timeFrame: 10 Year
measure: Range of motion
timeFrame: 10 Years
measure: Disc Height
timeFrame: 10 Years
measure: Heterotopic Ossification
timeFrame: 10 Years
measure: Adjacent Segment Degeneration
timeFrame: 10 Years
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange County Neurosurgical Associates
state: California
city: Rancho Mirage
country: United States
facility: Desert Orthopedic Center
state: California
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: Fort Wayne
country: United States
facility: Orthopedics Northeast
state: Indiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Tyler
country: United States
facility: Texas Spine and Joint Hospital
state: Texas
Study officials:
References:
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.
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.
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.
citation: 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.