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).
Study Type
OBSERVATIONAL
Enrollment
131
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.
Hoag Orthopedics
Orange, California, United States
The Spine Institute for Spine Restoration
Santa Monica, California, United States
Spine Education and Research
Thornton, Colorado, United States
Clinical Composite Success
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and 2. No device failures by month 120, and 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.
Time frame: 10 years
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 10 years
Treatment satisfaction questionnaire at each annual timepoint
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Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Texas Spine Consultants
Addison, Texas, United States
Texas Back Institute
Plano, Texas, United States
Responses range from very dissatisfied to very satisfied
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 10 years