Trial Outcomes & Findings for Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc (NCT NCT04980378)
NCT ID: NCT04980378
Last Updated: 2026-01-08
Results Overview
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."
Recruitment status
COMPLETED
Target enrollment
291 participants
Primary outcome timeframe
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 posted on
2026-01-08
Participant Flow
No recruitment - long term follow up of subjects previously enrolled in Investigational Device Exemption (IDE) and historical control data
Participant milestones
| Measure |
Simplify Disc
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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
A non-concurrent historical control was used with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm of a previously completed two-level cervical disc IDE trial. (Note: sponsor is unable to disclose NCT number of historical study due to contractual obligations)
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
134
|
|
Overall Study
COMPLETED
|
144
|
107
|
|
Overall Study
NOT COMPLETED
|
13
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
Baseline characteristics by cohort
| Measure |
Simplify Disc
n=157 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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=134 Participants
Historical ACDF Data from similar protocol used as control.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.35 years
STANDARD_DEVIATION 9.04 • n=18 Participants
|
47.71 years
STANDARD_DEVIATION 7.83 • n=17 Participants
|
48.59 years
STANDARD_DEVIATION 8.48 • n=35 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=18 Participants
|
71 Participants
n=17 Participants
|
154 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=18 Participants
|
63 Participants
n=17 Participants
|
137 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=18 Participants
|
122 Participants
n=17 Participants
|
268 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
8 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
157 Participants
n=18 Participants
|
134 Participants
n=17 Participants
|
291 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 140 Simplify Disc subjects had completed change in Neck Disability Index and neurologic data at 60 months due to missed questionnaires and/or neurologic exams.
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."
Outcome measures
| Measure |
Simplify Disc
n=140 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=107 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Clinical Composite Success
|
127 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 136 subjects had change in Arm Pain Intensity data at 60 months due to missed questionnaires. Likewise, 107 ACDF control subjects completed the 60-month visit, but 104 had change in Arm Pain Intensity data at 60 months.
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)
Outcome measures
| Measure |
Simplify Disc
n=136 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=104 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy
|
125 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 135 Simplify Disc subjects had SF-36 data available at 60 months due to missed questionnaires. Likewise, 107 ACDF subjects completed the 60-month visit, but 104 had SF-36 data available at 60 months.
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.
Outcome measures
| Measure |
Simplify Disc
n=135 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=104 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement
Maintenance or improvement
|
122 Participants
|
86 Participants
|
|
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement
Absence of maintenance or improvement
|
13 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 135 Simplify Disc subjects had SF-36 data available at 60 months due to missed questionnaires. Likewise, 107 ACDF subjects completed the 60-month visit, but 104 had SF-36 data available at 60 months.
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.
Outcome measures
| Measure |
Simplify Disc
n=135 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=104 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement
Maintenance or improvement
|
110 Participants
|
80 Participants
|
|
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement
Absence of maintenance or improvement
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Simplify Disc
n=144 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Dysphagia Handicap Index (DHI Scale)
|
7.1 score on a scale
Standard Deviation 11.6
|
—
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 143 subjects had evaluable treatment satisfaction data at 60 months.
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.
Outcome measures
| Measure |
Simplify Disc
n=143 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=107 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Patient Satisfaction
Definitely true
|
116 Participants
|
77 Participants
|
|
Patient Satisfaction
Mostly true
|
22 Participants
|
24 Participants
|
|
Patient Satisfaction
Don't know
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction
Mostly false
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction
Definitely false
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 141 subjects had evaluable Physician's Perception of Results data at 60 months due to missed questionnaires.
Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).
Outcome measures
| Measure |
Simplify Disc
n=141 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=107 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Physician's Perception
Excellent
|
126 Participants
|
57 Participants
|
|
Physician's Perception
Good
|
10 Participants
|
41 Participants
|
|
Physician's Perception
Fair
|
5 Participants
|
8 Participants
|
|
Physician's Perception
Poor
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.Population: While 144 Simplify Disc subjects completed the 60-month visit, 140 subjects had evaluable radiographs for this assessment at 60 months due to missed x-rays or poor image quality which limited analysis.
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.
Outcome measures
| Measure |
Simplify Disc
n=140 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Change in Average Disc Height (Superior Index Level)
|
1.10 mm
Standard Deviation 0.84
|
—
|
SECONDARY outcome
Timeframe: 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.Population: While 144 Simplify Disc subjects completed the 60-month visit, 131 subjects had evaluable radiographs for this assessment at 60 months due to missed x-rays or poor image quality which limited analysis.
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.
Outcome measures
| Measure |
Simplify Disc
n=131 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Change in Average Disc Height (Inferior Index Level)
|
0.81 mm
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: 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.Population: While 144 Simplify Disc subjects completed the 60-month visit, 137 Simplify Disc subjects had evaluable radiographs for this assessment at 60 months due to missed x-rays or poor image quality which limited analysis.
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 not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Outcome measures
| Measure |
Simplify Disc
n=137 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Adjacent Level Deterioration - Superior Adjacent Level
None
|
70 Participants
|
—
|
|
Adjacent Level Deterioration - Superior Adjacent Level
Doubtful
|
41 Participants
|
—
|
|
Adjacent Level Deterioration - Superior Adjacent Level
Minimal
|
20 Participants
|
—
|
|
Adjacent Level Deterioration - Superior Adjacent Level
Moderate
|
5 Participants
|
—
|
|
Adjacent Level Deterioration - Superior Adjacent Level
Severe
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.Population: While 144 Simplify Disc subjects completed the 60-month visit, 124 Simplify Disc subjects had evaluable radiographs for this assessment at 60 months due to missed x-rays or poor image quality which limited analysis.
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 not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Outcome measures
| Measure |
Simplify Disc
n=124 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Adjacent Level Deterioration - Inferior Adjacent Level
None
|
81 Participants
|
—
|
|
Adjacent Level Deterioration - Inferior Adjacent Level
Doubtful
|
23 Participants
|
—
|
|
Adjacent Level Deterioration - Inferior Adjacent Level
Minimal
|
13 Participants
|
—
|
|
Adjacent Level Deterioration - Inferior Adjacent Level
Moderate
|
5 Participants
|
—
|
|
Adjacent Level Deterioration - Inferior Adjacent Level
Severe
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 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 reportedPopulation: While 144 Simplify Disc subjects completed the 60-month visit, 140 subjects had evaluable radiographs for this assessment at 60 months due to missed x-rays or poor image quality which limited analysis. Likewise, 107 ACDF subjects completed the 60-month visit, but 102 had 60-month radiographs available for this assessments.
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.
Outcome measures
| Measure |
Simplify Disc
n=140 Participants
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF control data
n=102 Participants
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Displacement or Migration of the Device
Migration present at either index level
|
0 Participants
|
0 Participants
|
|
Displacement or Migration of the Device
Migration absent at both index levels
|
140 Participants
|
102 Participants
|
Adverse Events
Simplify Disc
Serious events: 40 serious events
Other events: 119 other events
Deaths: 0 deaths
ACDF: Historical ACDF Control Data
Serious events: 54 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simplify Disc
n=157 participants at risk
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF Control Data
n=134 participants at risk
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lumbar radiculopathy
|
8.3%
13/157 • Number of events 14 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
10.4%
14/134 • Number of events 14 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Infection (not at surgical site)
|
4.5%
7/157 • Number of events 8 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.5%
2/134 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Appendicular arthritis
|
1.9%
3/157 • Number of events 4 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
4.5%
6/134 • Number of events 6 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.9%
3/157 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.2%
3/134 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Other
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
3.0%
4/134 • Number of events 4 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
3.7%
5/134 • Number of events 5 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.2%
3/134 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Accidental trauma
|
1.9%
3/157 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.5%
2/134 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal complications
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.5%
2/134 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Cervical radiculopathy
|
1.9%
3/157 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (no narcotic given)
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Hematoma or seroma
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Stroke
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Renal and urinary disorders
Difficulty with urination
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Embolism
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Inflammation
|
0.64%
1/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Injury, poisoning and procedural complications
Blood loss (greater than 500 mL)
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Vertebral fracture
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Hypertension
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Thromboembolism
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.00%
0/134 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Nonunion/pseudoarthrosis
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
3.7%
5/134 • Number of events 5 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Psychiatric disorders
Psychological illness
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
2.2%
3/134 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Development of DDD at adjacent levels
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.5%
2/134 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Surgical and medical procedures
Surgery at a location other than the spine
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
1.5%
2/134 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Coordination abnormalities
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Headache
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Surgical and medical procedures
Surgery at another spine level
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Cardiac disorders
Cardiac event
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue damage
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Skin and subcutaneous tissue disorders
Dermatitis/Skin allergy
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Low back pain (narcotic given)
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Renal and urinary disorders
Renal dysfunction
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
0.75%
1/134 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
Other adverse events
| Measure |
Simplify Disc
n=157 participants at risk
Extended follow-up of IDE Subjects treated at two continuous levels with the Simplify Cervical Artificial Disc during IDE G150206
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.
|
ACDF: Historical ACDF Control Data
n=134 participants at risk
Historical ACDF Data from similar protocol used as control.
|
|---|---|---|
|
General disorders
Pain (no narcotic given)
|
20.4%
32/157 • Number of events 38 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
27.6%
37/134 • Number of events 43 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Accidental trauma
|
17.2%
27/157 • Number of events 30 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
29.1%
39/134 • Number of events 46 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Inflammation
|
19.1%
30/157 • Number of events 39 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
21.6%
29/134 • Number of events 33 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Cervical radiculopathy
|
18.5%
29/157 • Number of events 38 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
21.6%
29/134 • Number of events 30 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Lumbar radiculopathy
|
19.1%
30/157 • Number of events 37 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
20.9%
28/134 • Number of events 28 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Appendicular arthritis
|
7.0%
11/157 • Number of events 12 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
23.9%
32/134 • Number of events 43 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Infections and infestations
Infection (not at surgical site)
|
14.0%
22/157 • Number of events 27 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
13.4%
18/134 • Number of events 22 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Compressive neuropathy
|
11.5%
18/157 • Number of events 22 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
14.9%
20/134 • Number of events 20 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Headache
|
5.1%
8/157 • Number of events 8 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
17.2%
23/134 • Number of events 23 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Other
|
7.0%
11/157 • Number of events 13 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
14.2%
19/134 • Number of events 22 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Low back pain (no narcotic given)
|
6.4%
10/157 • Number of events 10 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.0%
12/134 • Number of events 12 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
General disorders
Pain (narcotic given)
|
5.1%
8/157 • Number of events 10 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
8.2%
11/134 • Number of events 11 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal complications
|
3.8%
6/157 • Number of events 6 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
15.7%
21/134 • Number of events 25 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Development of DDD at adjacent levels
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.7%
13/134 • Number of events 13 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Low back pain (narcotic given)
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.7%
13/134 • Number of events 13 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Non-Infectious pulmonary disorder
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
9.0%
12/134 • Number of events 13 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Nervous system disorders
Numbness - increased from pre-op or prior visit
|
3.2%
5/157 • Number of events 5 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
8.2%
11/134 • Number of events 12 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Spasm
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
8.2%
11/134 • Number of events 14 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
7/157 • Number of events 7 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.7%
9/134 • Number of events 9 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Cardiac disorders
Cardiac event
|
2.5%
4/157 • Number of events 4 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.7%
9/134 • Number of events 11 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.7%
9/134 • Number of events 9 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Psychiatric disorders
Psychological illness
|
1.9%
3/157 • Number of events 3 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.0%
8/134 • Number of events 12 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Vascular disorders
Hypertension
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.0%
8/134 • Number of events 8 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Skin and subcutaneous tissue disorders
Dermatitis/Skin allergy
|
1.3%
2/157 • Number of events 2 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
6.0%
8/134 • Number of events 8 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Musculoskeletal and connective tissue disorders
Nonunion/pseudoarthrosis
|
0.64%
1/157 • Number of events 1 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
5.2%
7/134 • Number of events 7 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
5.2%
7/134 • Number of events 7 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
|
Immune system disorders
Allergic rhinitis
|
0.00%
0/157 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
5.2%
7/134 • Number of events 7 • 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
All adverse events were reviewed and adjudicated by an independent Clinical Events Committee.
|
Additional Information
Jessica Fulwider, Lead Clinical Project Manager
Globus Medical
Phone: 703-772-1455
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