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.
Clinical Composite SuccessPrimary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Individual success for Simplify Disc was 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."
Group
Value
95% CI
Simplify Disc
127
ACDF: Historical ACDF control data
84
Clinically Significant Improvement in One or More Radicular Symptoms or MyelopathySecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
An arm pain questionnaire was used to measure radicular symptoms and compare to baseline symptoms in the IDE study. Changes of at least 2 points on a 10-point scale were regarded as clinically significant (0=no pain; 10=worst pain)
Group
Value
95% CI
Simplify Disc
125
ACDF: Historical ACDF control data
90
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or ImprovementSecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.
Group
Value
95% CI
Simplify Disc
122
ACDF: Historical ACDF control data
86
Simplify Disc
13
ACDF: Historical ACDF control data
18
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or ImprovementSecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.
Group
Value
95% CI
Simplify Disc
110
ACDF: Historical ACDF control data
80
Simplify Disc
25
ACDF: Historical ACDF control data
24
Dysphagia Handicap Index (DHI Scale)Secondary· Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Dysphagia Handicap Index score for the Simplify Disc subjects at 60 months. A higher score is indicative of a less desirable outcome. It is scored 0-100.
Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Group
Value
95% CI
Simplify Disc
7.1
± 11.6
Patient SatisfactionSecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Patient satisfaction was assessed by survey based on the response to the statement "I am satisfied with the results of my surgery" at 60 months. Answer options ranged from definitely true to definitely false.
Group
Value
95% CI
Simplify Disc
116
ACDF: Historical ACDF control data
77
Simplify Disc
22
ACDF: Historical ACDF control data
24
Simplify Disc
3
ACDF: Historical ACDF control data
4
Simplify Disc
2
ACDF: Historical ACDF control data
1
Physician's PerceptionSecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).
Group
Value
95% CI
Simplify Disc
126
ACDF: Historical ACDF control data
57
Simplify Disc
10
ACDF: Historical ACDF control data
41
Simplify Disc
5
ACDF: Historical ACDF control data
8
Simplify Disc
0
ACDF: Historical ACDF control data
1
Change in Average Disc Height (Superior Index Level)Secondary· Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Average disc height (superior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights.
Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Group
Value
95% CI
Simplify Disc
1.10
± 0.84
Change in Average Disc Height (Inferior Index Level)Secondary· Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Average disc height (inferior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights.
Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Group
Value
95% CI
Simplify Disc
0.81
± 0.94
Adjacent Level Deterioration - Superior Adjacent LevelSecondary· Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab.
Data was
Group
Value
95% CI
Simplify Disc
70
Simplify Disc
41
Simplify Disc
20
Simplify Disc
5
Adjacent Level Deterioration - Inferior Adjacent LevelSecondary· Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab.
Data was
Group
Value
95% CI
Simplify Disc
81
Simplify Disc
23
Simplify Disc
13
Simplify Disc
5
Displacement or Migration of the DeviceSecondary· Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Displacement or migration of the device at 60 months was be compared to immediate post-op data collected in the IDE study. This was be graded by the radiographic core lab. Migration was considered "present" if changes of \>3mm were noted. The superior index level and inferior index level was assessed separately.
Group
Value
95% CI
Simplify Disc
0
ACDF: Historical ACDF control data
0
Simplify Disc
140
ACDF: Historical ACDF control data
102
Adverse events — posted to ClinicalTrials.gov
Time frame: Data presented includes adverse events (AEs) collected under both the parent IDE study (G150206) and this Post Approval Study (PAS) for patients who enrolled in this PAS. Data collected from the time of surgery through 24 months was gathered in the IDE (NCT03123549; start date 4/1/17) and data for the same patient cohort from 24 months through 60 months post-op was gather under this PAS (start date 8/1/21). Comparison data from historical controls through 60 months post-op is also reported.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Simplify Disc
Serious: 40/157 (25%)
Deaths: 0/157
ACDF: Historical ACDF Control Data
Serious: 54/134 (40%)
Deaths: 0/134
Serious adverse events (39 terms)
Reaction
System
Simplify Disc
ACDF: Historical ACDF Cont…
Lumbar radiculopathy
Musculoskeletal and connective tissue disorders
—
—
Infection (not at surgical site)
Infections and infestations
—
—
Appendicular arthritis
Musculoskeletal and connective tissue disorders
—
—
Low back pain
Musculoskeletal and connective tissue disorders
—
—
Nonunion/pseudoarthrosis
Musculoskeletal and connective tissue disorders
—
—
Other
General disorders
—
—
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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
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/NCT04980378.