Eligibility, any sex, with Cervical Degenerative Disc Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)Primary· IDE study 24 months + PAS 36 months = 60 months total
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.
Group
Value
95% CI
Simplify Disc
117
Historical ACDF Control
40
Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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.
Group
Value
95% CI
Simplify Disc
97
Historical ACDF Control
23
Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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).
Group
Value
95% CI
Simplify Disc
16.8
± 12.1
Historical ACDF Control
23.8
± 26.1
Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.
Group
Value
95% CI
Simplify Disc
4.06
± 1.00
Historical ACDF Control
4.81
± 1.17
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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.
Group
Value
95% CI
Simplify Disc
52
Historical ACDF Control
6
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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.
Group
Value
95% CI
Simplify Disc
59
Historical ACDF Control
10
Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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)
Group
Value
95% CI
Simplify Disc
100
Historical ACDF Control
95
Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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".
How does the subject rate satisfaction with the treatment recieved?
Group
Value
95% CI
Simplify Disc
83
Historical ACDF Control
75
Would you choose to have the same treatment recieved?
Group
Value
95% CI
Simplify Disc
84
Historical ACDF Control
62
Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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.
Physical Component Score- PCS
Group
Value
95% CI
Simplify Disc
96
Mental Component Score
Group
Value
95% CI
Simplify Disc
71.8
Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)Secondary· IDE study 24 months + PAS 36 months = 60 months total
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.
Group
Value
95% CI
Simplify Disc
97
Historical ACDF Control
100
Adverse events — posted to ClinicalTrials.gov
Time frame: Data presented includes AEs collected under the Parent IDE study (G140154) and Post Approval Study (PAS). Data below represents AEs collected at post operative through 60 month follow up (IDE study 24 months + 36 months PAS).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Simplify Disc
Serious: 25/132 (19%)
Deaths: 1/132
Historical ACDF Control
Serious: 17/106 (16%)
Deaths: 0/106
Serious adverse events (20 terms)
Reaction
System
Simplify Disc
Historical ACDF Control
Adjacent Segment Degeneration
Musculoskeletal and connective tissue disorders
—
—
Gastrointestinal Complications
Gastrointestinal disorders
—
—
Infection - Not At Surgical Site
Infections and infestations
—
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NuVasive
Last refreshed: 8 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04630626.