Trial Outcomes & Findings for Post-Approval Study Protocol for the Simplify Cervical Artificial Disc (NCT NCT04630626)
NCT ID: NCT04630626
Last Updated: 2026-01-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
IDE study 24 months + PAS 36 months = 60 months total
Results posted on
2026-01-08
Participant Flow
No recruitment - long term follow up of subjects previously enrolled in IDE and historical control data
Participant milestones
| Measure |
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.
|
Historical ACDF Control
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
106
|
|
Overall Study
COMPLETED
|
125
|
65
|
|
Overall Study
NOT COMPLETED
|
17
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
Baseline characteristics by cohort
| Measure |
Simplify Disc
n=142 Participants
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.
|
Historical ACDF Control
n=106 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
n=9 Participants
|
43.9 years
n=6 Participants
|
43.6 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=9 Participants
|
63 Participants
n=6 Participants
|
152 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
96 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
123 Participants
n=9 Participants
|
93 Participants
n=6 Participants
|
216 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
142 Participants
n=9 Participants
|
106 Participants
n=6 Participants
|
248 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalIndividual 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.
Outcome measures
| Measure |
Simplify Disc
n=123 Participants
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.
|
Historical ACDF Control
n=63 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)
|
117 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalPopulation: Limited historical control neurological data available
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.
Outcome measures
| Measure |
Simplify Disc
n=122 Participants
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.
|
Historical ACDF Control
n=23 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)
|
97 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalEndpoint 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).
Outcome measures
| Measure |
Simplify Disc
n=124 Participants
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.
|
Historical ACDF Control
n=65 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)
|
16.8 score on a scale
Standard Deviation 12.1
|
23.8 score on a scale
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalDisc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.
Outcome measures
| Measure |
Simplify Disc
n=121 Participants
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.
|
Historical ACDF Control
n=63 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)
|
4.06 mm
Standard Deviation 1.00
|
4.81 mm
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalPopulation: Limited historical control data was available.
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.
Outcome measures
| Measure |
Simplify Disc
n=132 Participants
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.
|
Historical ACDF Control
n=63 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)
|
52 percentage of subjects with no ALDD
|
6 percentage of subjects with no ALDD
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalPopulation: Limited historical control data was available.
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.
Outcome measures
| Measure |
Simplify Disc
n=72 Participants
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.
|
Historical ACDF Control
n=6 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)
|
59 percentage of subjects with no ALDD
|
10 percentage of subjects with no ALDD
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalDisplacement 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)
Outcome measures
| Measure |
Simplify Disc
n=122 Participants
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.
|
Historical ACDF Control
n=60 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)
|
100 percentage of subjects with no migration
|
95 percentage of subjects with no migration
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalOverall 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".
Outcome measures
| Measure |
Simplify Disc
n=125 Participants
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.
|
Historical ACDF Control
n=63 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)
How does the subject rate satisfaction with the treatment recieved?
|
83 % of "Very Satisfied"/"Definitely Yes"
|
75 % of "Very Satisfied"/"Definitely Yes"
|
|
Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)
Would you choose to have the same treatment recieved?
|
84 % of "Very Satisfied"/"Definitely Yes"
|
62 % of "Very Satisfied"/"Definitely Yes"
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalPopulation: Questionnaire was only completed by subjects in the Simplify Disc arm. It was not collected for the historical control arm.
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.
Outcome measures
| Measure |
Simplify Disc
n=89 Participants
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.
|
Historical ACDF Control
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)
Physical Component Score- PCS
|
96 % of pts with maintenance or improvement
|
—
|
|
Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)
Mental Component Score
|
71.8 % of pts with maintenance or improvement
|
—
|
SECONDARY outcome
Timeframe: IDE study 24 months + PAS 36 months = 60 months totalDysphagia 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.
Outcome measures
| Measure |
Simplify Disc
n=118 Participants
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.
|
Historical ACDF Control
n=23 Participants
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)
|
97 percentage of subjects with no Dysphagia
|
100 percentage of subjects with no Dysphagia
|
Adverse Events
Simplify Disc
Serious events: 25 serious events
Other events: 105 other events
Deaths: 1 deaths
Historical ACDF Control
Serious events: 17 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simplify Disc
n=132 participants at risk
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.
|
Historical ACDF Control
n=106 participants at risk
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Adjacent Segment Degeneration
|
4.5%
6/132 • Number of events 6 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.8%
3/106 • Number of events 3 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal Complications
|
3.8%
5/132 • Number of events 5 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Infection - Not At Surgical Site
|
2.3%
3/132 • Number of events 3 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.8%
3/106 • Number of events 4 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.5%
2/132 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.8%
3/106 • Number of events 3 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Trauma
|
2.3%
3/132 • Number of events 3 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (Narcotic Given)
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.9%
2/106 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Surgery - Other Than the Spine
|
1.5%
2/132 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Radiculopathy
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.9%
2/106 • Number of events 4 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (No Narcotic Given)
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.9%
2/106 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
1.5%
2/132 • Number of events 2 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/106 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Ischemia
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Psychiatric disorders
Psychological Illness
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/106 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/132 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/132 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Compressive Neuropathy
|
0.00%
0/132 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Stroke
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/106 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Injury, poisoning and procedural complications
Adverse Reaction or Allergy to Anesthesia
|
0.00%
0/132 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Infection at Surgical Site
|
0.76%
1/132 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/106 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Headache
|
0.00%
0/132 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.94%
1/106 • Number of events 1 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
Other adverse events
| Measure |
Simplify Disc
n=132 participants at risk
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.
|
Historical ACDF Control
n=106 participants at risk
Historical ACDF Data from similar protocol used as control.
ACDF: Historical ACDF control data
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dysphagia
|
6.8%
9/132 • Number of events 10 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
3.8%
4/106 • Number of events 4 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (No Narcotic Given)
|
6.8%
9/132 • Number of events 9 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
15.1%
16/106 • Number of events 21 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Trauma
|
15.2%
20/132 • Number of events 24 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.6%
7/106 • Number of events 9 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (Narcotic Given)
|
6.1%
8/132 • Number of events 8 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
17.9%
19/106 • Number of events 27 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Other
|
11.4%
15/132 • Number of events 18 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
7.5%
8/106 • Number of events 10 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Infection - Not at Surgical Site
|
8.3%
11/132 • Number of events 13 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
3.8%
4/106 • Number of events 6 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Compressive Neuropathy
|
6.1%
8/132 • Number of events 9 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.4%
10/106 • Number of events 11 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Headache
|
6.1%
8/132 • Number of events 9 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
8.5%
9/106 • Number of events 11 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Increased Numbness
|
9.1%
12/132 • Number of events 15 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
4.7%
5/106 • Number of events 8 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal Complications
|
6.8%
9/132 • Number of events 10 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/106 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Radiculopathy
|
28.0%
37/132 • Number of events 45 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
19.8%
21/106 • Number of events 30 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Spasm
|
25.0%
33/132 • Number of events 35 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
21.7%
23/106 • Number of events 34 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Inflammation Conditions
|
17.4%
23/132 • Number of events 26 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
11.3%
12/106 • Number of events 15 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Adjacent Segment Degeneration
|
11.4%
15/132 • Number of events 18 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.4%
10/106 • Number of events 12 • 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)
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
Additional Information
Nicole Czaplewski, Manager Clinical Affairs
NuVasive, Inc.
Phone: 308-660-2021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication results vary per investigator and per clinical trial agreement.
- Publication restrictions are in place
Restriction type: OTHER