Cervical Degenerative Disc Disorder
Conditions
Keywords
Two Level
Brief summary
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc (Simplify Disc) in subjects enrolled in the non-randomized two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
Interventions
DEVICESimplify Disc
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
Sponsors
NuVasive
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- All subjects enrolled in the two level Simplify Disc IDE study are considered for this long-term follow-up study.
Exclusion criteria
* Subjects who were not implanted with the Simplify Disc during the IDE study * Subjects who had a secondary surgical intervention at the index level during the IDE study * Subjects who were withdrawn or withdrew consent to participate in the IDE study * Subjects who do not consent to participate in long-term follow-up post-approval study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite Success | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | Individual success for Simplify Disc was defined as follows: * Neck Disability Index (NDI) score improvement of at least 15 points from pre-operative; * Maintenance or improvement in neurological status; * No serious adverse event classified as implant associated or implant/surgical procedure associated; and * No additional surgical procedure classified as a failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | An arm pain questionnaire was used to measure radicular symptoms and compare to baseline symptoms in the IDE study. Changes of at least 2 points on a 10-point scale were regarded as clinically significant (0=no pain; 10=worst pain) |
| Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0. |
| Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0. |
| Dysphagia Handicap Index (DHI Scale) | 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. |
| Patient Satisfaction | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | Patient satisfaction was assessed by survey based on the response to the statement I am satisfied with the results of my surgery at 60 months. Answer options ranged from definitely true to definitely false. |
| Physician's Perception | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor). |
| Change in Average Disc Height (Superior Index Level) | Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative. | Average disc height (superior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. |
| Change in Average Disc Height (Inferior Index Level) | Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative. | Average disc height (inferior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. |
| Adjacent Level Deterioration - Superior Adjacent Level | Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative. | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was 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. |
| Adjacent Level Deterioration - Inferior Adjacent Level | Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative. | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was 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. |
| Displacement or Migration of the Device | Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported | Displacement or migration of the device at 60 months was be compared to immediate post-op data collected in the IDE study. This was be graded by the radiographic core lab. Migration was considered present if changes of \>3mm were noted. The superior index level and inferior index level was assessed separately. |
Countries
United States
Participant flow
Recruitment details
No recruitment - long term follow up of subjects previously enrolled in Investigational Device Exemption (IDE) and historical control data
Participants by arm
| Arm | Count |
|---|---|
| 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. | 157 |
| Historical ACDF Control Historical ACDF Data from similar protocol used as control. | 134 |
| Total | 291 |
Baseline characteristics
| Characteristic | Simplify Disc | Total | Historical ACDF Control |
|---|---|---|---|
| Age, Continuous | 49.35 years STANDARD_DEVIATION 9.04 | 48.59 years STANDARD_DEVIATION 8.48 | 47.71 years STANDARD_DEVIATION 7.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) White | 146 Participants | 268 Participants | 122 Participants |
| Region of Enrollment United States | 157 Participants | 291 Participants | 134 Participants |
| Sex: Female, Male Female | 83 Participants | 154 Participants | 71 Participants |
| Sex: Female, Male Male | 74 Participants | 137 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 134 |
| other Total, other adverse events | 119 / 157 | 126 / 134 |
| serious Total, serious adverse events | 40 / 157 | 54 / 134 |
Outcome results
Primary
Clinical Composite Success
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simplify Disc | Clinical Composite Success | 127 Participants |
| ACDF: Historical ACDF control data | Clinical Composite Success | 84 Participants |
Secondary
Adjacent Level Deterioration - Inferior Adjacent Level
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Adjacent Level Deterioration - Inferior Adjacent Level | None | 81 Participants |
| Simplify Disc | Adjacent Level Deterioration - Inferior Adjacent Level | Doubtful | 23 Participants |
| Simplify Disc | Adjacent Level Deterioration - Inferior Adjacent Level | Minimal | 13 Participants |
| Simplify Disc | Adjacent Level Deterioration - Inferior Adjacent Level | Moderate | 5 Participants |
| Simplify Disc | Adjacent Level Deterioration - Inferior Adjacent Level | Severe | 2 Participants |
Secondary
Adjacent Level Deterioration - Superior Adjacent Level
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Adjacent Level Deterioration - Superior Adjacent Level | None | 70 Participants |
| Simplify Disc | Adjacent Level Deterioration - Superior Adjacent Level | Doubtful | 41 Participants |
| Simplify Disc | Adjacent Level Deterioration - Superior Adjacent Level | Minimal | 20 Participants |
| Simplify Disc | Adjacent Level Deterioration - Superior Adjacent Level | Moderate | 5 Participants |
| Simplify Disc | Adjacent Level Deterioration - Superior Adjacent Level | Severe | 1 Participants |
Secondary
Change in Average Disc Height (Inferior Index Level)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simplify Disc | Change in Average Disc Height (Inferior Index Level) | 0.81 mm | Standard Deviation 0.94 |
Secondary
Change in Average Disc Height (Superior Index Level)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simplify Disc | Change in Average Disc Height (Superior Index Level) | 1.10 mm | Standard Deviation 0.84 |
Secondary
Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy
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)
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simplify Disc | Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy | 125 Participants |
| ACDF: Historical ACDF control data | Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy | 90 Participants |
Secondary
Displacement or Migration of the Device
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.
Time frame: 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
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. Likewise, 107 ACDF subjects completed the 60-month visit, but 102 had 60-month radiographs available for this assessments.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Displacement or Migration of the Device | Migration present at either index level | 0 Participants |
| Simplify Disc | Displacement or Migration of the Device | Migration absent at both index levels | 140 Participants |
| ACDF: Historical ACDF control data | Displacement or Migration of the Device | Migration present at either index level | 0 Participants |
| ACDF: Historical ACDF control data | Displacement or Migration of the Device | Migration absent at both index levels | 102 Participants |
Secondary
Dysphagia Handicap Index (DHI Scale)
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simplify Disc | Dysphagia Handicap Index (DHI Scale) | 7.1 score on a scale | Standard Deviation 11.6 |
Secondary
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement | Maintenance or improvement | 110 Participants |
| Simplify Disc | Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement | Absence of maintenance or improvement | 25 Participants |
| ACDF: Historical ACDF control data | Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement | Maintenance or improvement | 80 Participants |
| ACDF: Historical ACDF control data | Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement | Absence of maintenance or improvement | 24 Participants |
Secondary
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement | Maintenance or improvement | 122 Participants |
| Simplify Disc | Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement | Absence of maintenance or improvement | 13 Participants |
| ACDF: Historical ACDF control data | Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement | Maintenance or improvement | 86 Participants |
| ACDF: Historical ACDF control data | Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement | Absence of maintenance or improvement | 18 Participants |
Secondary
Patient Satisfaction
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.
Time frame: 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
Population: While 144 Simplify Disc subjects completed the 60-month visit, 143 subjects had evaluable treatment satisfaction data at 60 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Patient Satisfaction | Mostly true | 22 Participants |
| Simplify Disc | Patient Satisfaction | Mostly false | 2 Participants |
| Simplify Disc | Patient Satisfaction | Don't know | 3 Participants |
| Simplify Disc | Patient Satisfaction | Definitely false | 0 Participants |
| Simplify Disc | Patient Satisfaction | Definitely true | 116 Participants |
| ACDF: Historical ACDF control data | Patient Satisfaction | Definitely false | 1 Participants |
| ACDF: Historical ACDF control data | Patient Satisfaction | Definitely true | 77 Participants |
| ACDF: Historical ACDF control data | Patient Satisfaction | Mostly true | 24 Participants |
| ACDF: Historical ACDF control data | Patient Satisfaction | Don't know | 4 Participants |
| ACDF: Historical ACDF control data | Patient Satisfaction | Mostly false | 1 Participants |
Secondary
Physician's Perception
Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Simplify Disc | Physician's Perception | Good | 10 Participants |
| Simplify Disc | Physician's Perception | Excellent | 126 Participants |
| Simplify Disc | Physician's Perception | Fair | 5 Participants |
| Simplify Disc | Physician's Perception | Poor | 0 Participants |
| ACDF: Historical ACDF control data | Physician's Perception | Poor | 1 Participants |
| ACDF: Historical ACDF control data | Physician's Perception | Good | 41 Participants |
| ACDF: Historical ACDF control data | Physician's Perception | Fair | 8 Participants |
| ACDF: Historical ACDF control data | Physician's Perception | Excellent | 57 Participants |