Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

NuVasive10 sites in 1 country131 target enrollmentFebruary 9, 2022

ConditionsCervical Disc Disease Degenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cervical Disc Disease
Sponsor: NuVasive
Enrollment: 131
Locations: 10
Primary Endpoint: Clinical Composite Success
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).

Registry

clinicaltrials.gov

Start Date

February 9, 2022

End Date

April 1, 2028

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

NuVasive

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
•Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion Criteria

•Subject had an SSI at the index level during the post approval study (NCT04630626)
•Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Outcomes

Primary Outcomes

Clinical Composite Success

Time Frame: 10 years

Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and 2. No device failures by month 120, and 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.

Secondary Outcomes

Sensory status at each annual timepoint compared to baseline(10 years)
Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067)(10 years)
Motor status at each annual timepoint compared to baseline(10 years)
Treatment satisfaction questionnaire at each annual timepoint(10 years)
Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint(10 years)
Disc height at each annual timepoint will be compared to baseline(10 years)
Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain(10 years)
Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline(10 years)
Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline(10 years)
Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint(10 years)
Range of motion (ROM) at each annual timepoint compared to baseline(10 years)
SF-12v2® Health Survey at each annual timepoint compared to baseline(10 years)