Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

Study Overview
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Brief Summary
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This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc (Simplify Disc) in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.

Official Title
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Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc

Conditions
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Cervical Degenerative Disc Disorder

Intervention / Treatment
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* Device: Simplify Disc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study. Exclusion Criteria: Subjects who were not implanted with the Simplify Disc during the IDE study Subjects who had a secondary surgical intervention at the index level during the IDE study Subjects who were withdrawn or withdrew consent to participate in the IDE study Subjects who do not consent to participate in long-term follow-up post-approval study
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 IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 | Device: Simplify Disc<br>* The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Composite Success | Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows: Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and No device failures by Month 60, and No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60. | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement in one or more radicular symptoms or myelopathy (neurological status) | Endpoint will be examined using Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at each visit compared to baseline from the IDE | 60 Months | 
| Clinical Improvement in one or more radicular symptoms or myelopathy (Visual Analog Scale) | Endpoint will be examined using the Visual Analog Scale (VAS) which is a straight horizontal line of fixed length (100 millimeters) oriented from the left (best) to the right (worst) | 60 Months | 
| Disc Height | Disc height will be compared to baseline from the IDE | 60 Months | 
| Adjacent level Deterioration | Adjacent level Deterioration will be compared to baseline from the IDE | 60 Months | 
| Displacement or Migration of the device | Displacement or Migration of the device will be compared to baseline from the IDE (changes of >3 mm will be considered significant) | 60 Months | 
| Treatment Satisfaction | Treatment satisfaction will be examined at 60 months. This will be collected via a questionnaire, completed by the subject, that will ask questions regarding overall satisfaction with treatment, relief from symptoms, exercise, and activity levels. | 60 Months | 
| 12-Item Short Form Survey (SF-12) | 12-Item Short Form Survey (SF-12) will be compared to baseline from the IDE | 60 Months | 
| Dysphagia Handicap Index (DHI) | Dysphagia Handicap Index (DHI) will be compared to baseline from the IDE | 60 Months |