| Primary | Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS) | 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.
| | Posted | | Count of Participants | | Participants | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS) | Endpoint includes the number of participates in each group that had improvement in one or more radicular symptoms or myelopathy based on their Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at 60 months when compared to baseline data from the prior IDE study. | Limited historical control neurological data available | Posted | | Count of Participants | | Participants | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS) | Endpoint was examined using the Visual Analog Scale (VAS) for neck and arm pain which is a straight horizontal line of fixed length (100 millimeters) oriented from zero or no pain (best) to 100mm or the worst pain ever (worst). | | Posted | | Mean | Standard Deviation | score on a scale | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS) | Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level. | | Posted | | Mean | Standard Deviation | mm | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS) | Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe. | Limited historical control data was available. | Posted | | Number | | percentage of subjects with no ALDD | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS) | Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe. | Limited historical control data was available. | Posted | | Number | | percentage of subjects with no ALDD | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS) | Displacement or Migration of the device will be compared device placement at 60 months to immediate post-op data collected under the IDE study (changes of >3 mm will be considered significant) | | Posted | | Number | | percentage of subjects with no migration | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS) | Overall Treatment satisfaction was examined at 60 months. This was collected via a questionnaire completed by the subject. Response options to "How does the subject rate satisfaction with the treatment received?" included "Very Satisfied", "Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied", and "Very Dissatisfied". Response options to "If you could go back in time, would you choose to have the same treatment that you received for your neck condition?" included "Definitely Yes", "Probably Yes", "Maybe", "Probably Not" and "Definitely Not". | | Posted | | Number | | % of "Very Satisfied"/"Definitely Yes" | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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| Secondary | Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS) | 12-Item Short Form Survey (SF-12) is a questionnaire completed by the subject. Outcomes will be comparted at 60 months post treatment to baseline data collected from the IDE study. | Questionnaire was only completed by subjects in the Simplify Disc arm. It was not collected for the historical control arm. | Posted | | Number | | % of pts with maintenance or improvement | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. |
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| Secondary | Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS) | Dysphagia Handicap Index (DHI) is a questionnaire completed by the subject. Outcomes at 60 months post-op were compared to baseline data collected under the IDE study. | | Posted | | Number | | percentage of subjects with no Dysphagia | | IDE study 24 months + PAS 36 months = 60 months total | | | | ID | Title | Description |
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| OG000 | Simplify Disc | Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 Simplify Disc: The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. | | OG001 | Historical ACDF Control | Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data |
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