Post Approval Study Protocol for the Two Level 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Official Title
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Post Approval Study Protocol for the Two Level 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 two level 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IDE study Subjects who had a secondary surgical intervention at the index level during the IDE study Subjects who were withdrawn or withdrew consent to participate in the IDE study Subjects who do not consent to participate in long-term follow-up post-approval study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 at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206 | 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 is defined as follows: Neck Disability Index (NDI) score improvement of at least 15 points from pre-operative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No additional surgical procedure classified as a failure. | 60 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant improvement in one or more radicular symptoms or myelopathy | Clinically significant improvement in one or more radicular symptoms or myelopathy at each annual timepoint compared to baseline in the IDE study for the two level Simplify Disc. Endpoints will be graded based on pain questionnaires, motor status, and sensory status. | 60 Months | 
| Time to recovery | Time to recovery defined as the earliest time at which a minimum 15-point (out of 100) NDI improvement is reached. | 60 Months | 
| Disc Height | Disc height at each annual timepoint compared to baseline (6 weeks) in the IDE study for the two level Simplify Disc. Both levels had to be a disc height success to claim success for overall disc height. This will be graded by the radiographic core laboratory. | 60 Months | 
| Adjacent Level Deterioration | Adjacent level deterioration at each annual timepoint compared to baseline in the investigational group of the IDE study for the two level Simplify Disc. This will be graded by the radiographic core laboratory. | 60 Months | 
| Displacement or Migration of the Device | Displacement or migration of the device will be compared to baseline in the IDE. This will be graded by the radiographic core lab. | 60 Months | 
| Work Status | Return to work status post-operatively. The subjects will be surveyed for this at each follow-up visit | 60 Months | 
| Patient Satisfaction | Patient satisfaction and perceived effect at each annual timepoint. Success will be graded via a survey response of 'Definitely True' or 'Mostly True' | 60 Months | 
| Health Survey; 36-Item Short Form Survey (SF-36) | Health Survey at each annual timepoint compared to baseline. | 60 Months | 
| Dysphagia Handicap Index (DHI scale) | Dysphagia Handicap Index (DHI scale) for the Simplify Disc at 60 months compared to baseline in the two level IDE study. | 60 Months | 
| Adjacent Level Motion (Stability) | Adjacent Level Motion (Stability) will be compared at 60 months to baseline. This will be graded by the radiographic core lab. | 60 Months | 
| Physician's Perception | Results at 60 months will be categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor). | 60 Months | 
| Gait Assessment | Gait assessment at 60 months compared to baseline. This will be based on Nurick's classification. Success will be defined as maintenance or improvement in the post-operative status as compared to the pre-operative condition. | 60 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Two Level