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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cervical Disc Disease, Degenerative Disc Disease

Intervention / Treatment
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* Device: NuVasive Simplify Cervical Artificial Disc


Participation Criteria
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Eligibility Criteria
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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Exclusion Criteria: Subject had an SSI at the index level during the post approval study (NCT04630626) Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simplify Disc<br>Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626. | Device: NuVasive Simplify Cervical Artificial Disc<br>* Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Composite Success | Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and No device failures by month 120, and No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint | Neck Disability Index; scale is reported in a range from 0-100, with 0 consistent with best ability to function and 100 worst ability to function. | 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 | Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 with most pain | 10 years | 
| Motor status at each annual timepoint compared to baseline | A change of one or more grade levels in muscle strength will be regarded as clinically significant. | 10 years | 
| Sensory status at each annual timepoint compared to baseline | Sensation will be graded as normal or abnormal (diminished or absent). Any changes from abnormal to normal or absent to diminished will be regarded as clinically significant improvement. | 10 years | 
| Treatment satisfaction questionnaire at each annual timepoint | Responses range from very dissatisfied to very satisfied | 10 years | 
| SF-12v2® Health Survey at each annual timepoint compared to baseline | The SF-12 is a multipurpose short form survey with 12 questions selected from the SF-36 Health Survey. The questions were combined, scored and weighted to create mental and physical functioning and overall health-related quality of life. Higher scores indicate better outcomes. Scores range from 0-15. | 10 years | 
| Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline | DHI is scored from 0-100, with a higher score indicative of a less desirable outcome. | 10 years | 
| Disc height at each annual timepoint will be compared to baseline | Average disc height is calculated as the simple average of the anterior and posterior disc heights | 10 years | 
| Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline | ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe | 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) | Device migration assesses significant movement of the implant postoperatively | 10 years | 
| Range of motion (ROM) at each annual timepoint compared to baseline | Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances. | 10 years | 
| Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint | Number of adverse events related to Simplify Disc or additional NuVasive products | 10 years |