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.
This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
Historical ACDF control data
Orthopaedic Education and Research Institute of Southern California
Orange, California, United States
USCD
San Diego, California, United States
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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).
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)
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The Spine Institute for Spine Restoration
Santa Monica, California, United States
Spine Education and Research Foundation
Thornton, Colorado, United States
Kennedy-White orthopedic Center
Sarasota, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Spine institute of Louisiana
Shreveport, Louisiana, United States
Rothman Institute
Egg Harbor, New Jersey, United States
...and 5 more locations
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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)
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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".
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total
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.
Time frame: IDE study 24 months + PAS 36 months = 60 months total