Trial Outcomes & Findings for Investigation of the Simplify® Cervical Artificial Disc (NCT NCT02667067)

Last Updated: 2026-01-08

Results Overview

Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

Baseline, 24 Months

Results posted on

2026-01-08

Participant Flow

Subjects were recruited across 16 clinical sites in the United States

This is a non-randomized study. The 117 ACDF subjects are a historical control group. (Kineflex C Study; NCT#00374413)

Participant milestones

Participant milestones
Measure	Anterior Cervical Discectomy & Fusion (ACDF) Anterior Cervical Discectomy \& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Overall Study STARTED	117	150
Overall Study COMPLETED	96	139
Overall Study NOT COMPLETED	21	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of the Simplify® Cervical Artificial Disc

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anterior Cervical Discectomy & Fusion (ACDF) n=117 Participants Anterior Cervical Discectomy \& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=150 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.	Total n=267 Participants Total of all reporting groups
Age, Continuous	44.1 Years STANDARD_DEVIATION 7.0 • n=18 Participants	43.0 Years STANDARD_DEVIATION 8.9 • n=17 Participants	43.5 Years STANDARD_DEVIATION 8.13 • n=35 Participants
Sex: Female, Male Female	68 Participants n=18 Participants	91 Participants n=17 Participants	159 Participants n=35 Participants
Sex: Female, Male Male	49 Participants n=18 Participants	59 Participants n=17 Participants	108 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	0 Participants n=18 Participants	0 Participants n=17 Participants	0 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	7 Participants n=18 Participants	10 Participants n=17 Participants	17 Participants n=35 Participants
Race (NIH/OMB) White	103 Participants n=18 Participants	131 Participants n=17 Participants	234 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	7 Participants n=18 Participants	9 Participants n=17 Participants	16 Participants n=35 Participants
Region of Enrollment United States	117 Participants n=18 Participants	150 Participants n=17 Participants	267 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline, 24 Months

Population: Success is presented on observed data only

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=96 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=142 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Number of Participants With Composite Clinical Success (CCS) of Simplify Disc	68 Participants	132 Participants

SECONDARY outcome

Timeframe: Baseline, 3 Months

Population: Data is presented on available NDI scores.

Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=111 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=145 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) 15-Point Improvement (No)	21 Participants	6 Participants
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) 15-Point Improvement (Yes)	90 Participants	139 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Presented data available for comparison (preop and at month 24)

Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain)

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
VAS Neck and Arm Pain Success	83 Participants	134 Participants
VAS Neck and Arm Pain Failure	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Subjects were analyzed based on available 24-month data.

Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Neurological Status Improved	52 Participants	111 Participants
Neurological Status Maintained	38 Participants	27 Participants
Neurological Status Deteriorated	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Subjects analyzed based on available data at month 24. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.

The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. 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. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=138 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
SF-12 Physical Component Score (PCS) Maintenance or Improvement Maintenance or Improvement	129 Participants	—
SF-12 Physical Component Score (PCS) Maintenance or Improvement Absence of Maintenance or Improvement	9 Participants	—

SECONDARY outcome

Timeframe: Baseline, 24 Months

The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. 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. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=138 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
SF-12 Mental Component Score (MCS) Maintenance or Improvement Maintenance or Improvement	105 Participants	—
SF-12 Mental Component Score (MCS) Maintenance or Improvement Absence of Maintenance or Improvement	33 Participants	—

SECONDARY outcome

Timeframe: 24 Months

Population: Presented data on available survey responses at Month 24

Question 1 - "how does the subject rate satisfaction with the treated received" was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=96 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=138 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Patient Questionnaires- Treatment Satisfaction Health Survey- Very Satisfied	67 Participants	122 Participants
Patient Questionnaires- Treatment Satisfaction Health Survey- Satisfied	20 Participants	12 Participants
Patient Questionnaires- Treatment Satisfaction Health Survey- Somewhat Satisfied	5 Participants	2 Participants
Patient Questionnaires- Treatment Satisfaction Health Survey- Somewhat Dissatisfied	3 Participants	2 Participants
Patient Questionnaires- Treatment Satisfaction Health Survey- Dissatisfied	1 Participants	0 Participants
Patient Questionnaires- Treatment Satisfaction Health Survey- Very Dissatisfied	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Data presented on subject's with Odom's Criteria result at Month 24

Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Odom's Criteria Results Fair	8 Participants	5 Participants
Odom's Criteria Results Poor	5 Participants	1 Participants
Odom's Criteria Results Excellent	64 Participants	121 Participants
Odom's Criteria Results Good	18 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data analyzed based on available 24-month DHI scores. 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.

Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. 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

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=138 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Dysphagia Handicap Index (DHI)	-2.3 score on a scale Standard Deviation 8.6	—

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=91 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=135 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Average Disc Height (Index Level)	1.46 millimeters Standard Deviation 1.24	0.93 millimeters Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=91 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=137 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Average Disc Height (Above the Index Level)	-0.05 millimeters Standard Deviation 0.40	0 millimeters Standard Deviation 0.23

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=59 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=106 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Average Disc Height (Below the Index Level)	-0.07 millimeters Standard Deviation 0.26	-0.07 millimeters Standard Deviation 0.31

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Superior Adjacent Level Disc Degeneration None	15 Participants	87 Participants
Superior Adjacent Level Disc Degeneration Mild	22 Participants	26 Participants
Superior Adjacent Level Disc Degeneration Moderate	36 Participants	20 Participants
Superior Adjacent Level Disc Degeneration Severe	20 Participants	3 Participants
Superior Adjacent Level Disc Degeneration Unable to assess	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Inferior Adjacent Level Disc Degeneration None	14 Participants	95 Participants
Inferior Adjacent Level Disc Degeneration Mild	15 Participants	15 Participants
Inferior Adjacent Level Disc Degeneration Moderate	23 Participants	16 Participants
Inferior Adjacent Level Disc Degeneration Severe	10 Participants	2 Participants
Inferior Adjacent Level Disc Degeneration Unable to assess	33 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24

Device migration assesses significant movement of the implant postoperatively

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=95 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=139 Participants Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Device Migration Unable to assess	5 Participants	2 Participants
Device Migration Right	0 Participants	0 Participants
Device Migration None	90 Participants	137 Participants
Device Migration Anterior	0 Participants	0 Participants
Device Migration Posterior	0 Participants	0 Participants
Device Migration Left	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 24 Months

Population: Data presented on available images at Month 24. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.

Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.

Outcome measures

Outcome measures
Measure	Anterior cervical discectomy & fusion (ACDF) n=139 Participants Anterior Cervical Discectomy \& Fusion: This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Facet Deterioration None	80 Participants	—
Facet Deterioration Mild	42 Participants	—
Facet Deterioration Moderate	9 Participants	—
Facet Deterioration Severe	1 Participants	—
Facet Deterioration Unable to Assess	7 Participants	—

Adverse Events

Anterior Cervical Discectomy & Fusion (ACDF)

Serious events: 16 serious events

Other events: 65 other events

Deaths: 0 deaths

Simplify Disc

Serious events: 17 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Anterior Cervical Discectomy & Fusion (ACDF) n=117 participants at risk Anterior Cervical Discectomy \& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=150 participants at risk Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Musculoskeletal and connective tissue disorders Spasm	4.3% 5/117 • Number of events 6 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	15.3% 23/150 • Number of events 24 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Injury, poisoning and procedural complications Trauma	6.0% 7/117 • Number of events 8 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	8.0% 12/150 • Number of events 12 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Injury, poisoning and procedural complications Other	5.1% 6/117 • Number of events 8 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	8.7% 13/150 • Number of events 15 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Gastrointestinal disorders Dysphagia	2.6% 3/117 • Number of events 3 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	5.3% 8/150 • Number of events 9 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Infections and infestations Infections (All other infections NOT at cervical surgical site)	4.3% 5/117 • Number of events 7 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	5.3% 8/150 • Number of events 12 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Inflammation	10.3% 12/117 • Number of events 14 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	10.7% 16/150 • Number of events 18 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Adjacent Segment Degeneration	6.8% 8/117 • Number of events 8 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	6.7% 10/150 • Number of events 11 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Nervous system disorders Radiculopathy	17.9% 21/117 • Number of events 29 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	19.3% 29/150 • Number of events 35 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Pain (No narcotic given)	12.8% 15/117 • Number of events 18 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	9.3% 14/150 • Number of events 15 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Nervous system disorders Compressive Neuropathy	7.7% 9/117 • Number of events 10 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	2.7% 4/150 • Number of events 4 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Nervous system disorders Headache	10.3% 12/117 • Number of events 14 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	4.0% 6/150 • Number of events 8 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Pain (Narcotic given)	17.9% 21/117 • Number of events 29 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	7.3% 11/150 • Number of events 11 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Gastrointestinal disorders GI Complications	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	5.3% 8/150 • Number of events 9 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.

Additional Information

Nicole Czaplewski

NuVasive, Inc.

Phone: 308-660-2021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication results vary per investigator and per clinical trial agreement.
Publication restrictions are in place

Restriction type: OTHER

Measure	Anterior Cervical Discectomy & Fusion (ACDF) n=117 participants at risk Anterior Cervical Discectomy \& Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\\|C Disc trial.	Simplify Disc n=150 participants at risk Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine.
Infections and infestations Infections (all other infections - NOT at cervical surgical site)	0.85% 1/117 • Number of events 2 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	1.3% 2/150 • Number of events 2 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Pseduoarthrosis	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Injury, poisoning and procedural complications Trauma	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Headache	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Radiculopathy	1.7% 2/117 • Number of events 4 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Psychiatric disorders Psychological Illness	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Pain (narcotic given)	2.6% 3/117 • Number of events 3 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	1.3% 2/150 • Number of events 2 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Adjacent Segment Degeneration	2.6% 3/117 • Number of events 3 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	1.3% 2/150 • Number of events 3 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Surgical and medical procedures Surgery at a location other than the spine	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	1.3% 2/150 • Number of events 5 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Gastrointestinal disorders Gastrointestinal Complications	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	2.0% 3/150 • Number of events 3 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Inflammation Conditions	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Injury, poisoning and procedural complications Esophageal Perforation	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Infections and infestations Infection; localized to cervical surgical site	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Cardiac disorders Ischemia	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Infections and infestations Deep wound infection; localized to cervical surgical site	0.00% 0/117 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.67% 1/150 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Product Issues Implant Collapse or Subsidence	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Musculoskeletal and connective tissue disorders Pain (No Narcotic Given)	1.7% 2/117 • Number of events 2 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Vascular disorders Thrombosis	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Injury, poisoning and procedural complications Other	0.85% 1/117 • Number of events 1 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	1.7% 2/117 • Number of events 2 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.	0.00% 0/150 • Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.