Trial Outcomes & Findings for SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study (NCT NCT00882661)

NCT ID: NCT00882661

Last Updated: 2017-06-09

Results Overview

Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 380 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2017-06-09

Participant Flow

Participant milestones

Measure	SECURE-C Cervical Artificial Disc Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
Investigational Training STARTED	89	0
Investigational Training COMPLETED	79	0
Investigational Training NOT COMPLETED	10	0
Treatment STARTED	151	140
Treatment COMPLETED	141	114
Treatment NOT COMPLETED	10	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

Baseline characteristics by cohort

Measure	Randomized SECURE-C Cervical Artificial Disc n=151 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and Allograft Interbody Spacer n=140 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=89 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc	Total n=380 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	44.4 years STANDARD_DEVIATION 7.9 • n=7 Participants	41.6 years STANDARD_DEVIATION 8.13 • n=5 Participants	43.9 years STANDARD_DEVIATION 7.7 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	72 Participants n=7 Participants	42 Participants n=5 Participants	184 Participants n=4 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	68 Participants n=7 Participants	47 Participants n=5 Participants	196 Participants n=4 Participants
Region of Enrollment United States	151 participants n=5 Participants	140 participants n=7 Participants	89 participants n=5 Participants	291 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.

Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=141 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=114 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=79 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Individual Patient Overall Success	127 participants	81 participants	67 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.

Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=139 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=116 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=78 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Neck Disability Index (NDI)	127 participants	101 participants	67 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.

Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=133 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=108 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=75 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Neck Pain Visual Analog Scale (VAS)	104 participants	76 participants	54 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.

Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=133 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=108 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=75 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Left Arm Pain Visual Analog Scale (VAS)	74 participants	55 participants	37 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.

Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=133 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=108 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=75 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Right Arm Pain Visual Analog Scale (VAS)	57 participants	49 participants	36 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.

Health Status Survey SF-36 physical composite scores: 15% improvement from baseline

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=138 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=114 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=78 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
SF-36 PCS	109 participants	89 participants	53 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.

Health Status Survey SF-36 mental composite scores: 15% improvement from baseline

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=138 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=114 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=78 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
SF-36 MCS	70 participants	48 participants	45 participants

SECONDARY outcome

Timeframe: 24 months

Population: At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.

Patient satisfaction (definitely/mostly): proportion of patients

Outcome measures

Measure	Randomized SECURE-C Cervical Artificial Disc n=139 Participants Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=115 Participants Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion	Non-Randomized SECURE-C Cervical Artificial Disc n=78 Participants The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
Satisfaction	133 participants	98 participants	72 participants

Adverse Events

SECURE-C Cervical Artificial Disc

Serious events: 46 serious events

Other events: 121 other events

Deaths: 0 deaths

ASSURE Cervical Plate and an Allograft Interbody Spacer

Serious events: 34 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	SECURE-C Cervical Artificial Disc n=236 participants at risk Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=144 participants at risk Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Cardiac disorders Cardiovascular	2.1% 5/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Carpal Tunnel Syndrome (CTS)	2.5% 6/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.1% 3/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Vascular disorders Cerebrovascular	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Compressive Periph Neuro (Non-CTS)	1.3% 3/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Death	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Dysphagia	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Gastrointestinal disorders Gastrointestinal	1.7% 4/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Infections and infestations Infection - Other	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.5% 13/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	3.5% 5/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Neurological	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Other	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Musculoskeletal and connective tissue disorders Pain - Back and/or Lower Extremities	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Musculoskeletal and connective tissue disorders Pain - Upper Extremities	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Psychiatric disorders Psychological	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Surgical and medical procedures Surgery - Adjacent Level	1.7% 4/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Surgical and medical procedures Surgery - Index Level	2.5% 6/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	9.7% 14/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Surgical and medical procedures Surgery - Lumbar Level	2.5% 6/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	3.5% 5/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Surgical and medical procedures Surgery - Other Cervical	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Surgical and medical procedures Surgery - Thoracic Level	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Injury, poisoning and procedural complications Trauma	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Renal and urinary disorders Urogenital	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.

Other adverse events

Measure	SECURE-C Cervical Artificial Disc n=236 participants at risk Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc	ASSURE Cervical Plate and an Allograft Interbody Spacer n=144 participants at risk Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
General disorders Cancer	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Cardiac disorders Cardiovascular	1.3% 3/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Carpal Tunnel Syndrome (CTS)	2.5% 6/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	3.5% 5/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Vascular disorders Cerebrovascular	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Compressive Peripheral Neuropathy (Non-CTS)	1.7% 4/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.00% 0/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Dysesthesia - Lower Extremities	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Dysesthesia - Other	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.1% 3/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Dysesthesia - Upper Extremities	8.5% 20/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	10.4% 15/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Dysphagia	2.5% 6/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	4.9% 7/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Dysphonia	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Gastrointestinal disorders Gastrointestinal	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Headache	3.4% 8/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	7.6% 11/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Infections and infestations Infection - Other	1.3% 3/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Infections and infestations Infection - Superficial Wound	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal	7.2% 17/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.8% 4/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Nervous system disorders Neurological	1.3% 3/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Other	4.2% 10/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.1% 3/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Back and/or Lower Extremities	14.4% 34/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	16.0% 23/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Neck	21.2% 50/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	28.5% 41/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Neck and Upper Extremities	11.0% 26/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	19.4% 28/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Neck and Upper Extremities with Dysesthesia	0.42% 1/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.1% 3/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Neck with Dysesthesia	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.8% 4/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Other	0.85% 2/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Upper Extremities	13.6% 32/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	16.0% 23/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Pain - Upper Extremities with Dysesthesia	2.1% 5/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	1.4% 2/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Psychiatric disorders Psychological	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Injury, poisoning and procedural complications Trauma	12.7% 30/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	11.1% 16/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
General disorders Weakness	1.3% 3/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	0.69% 1/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.
Skin and subcutaneous tissue disorders Wound Issue	0.00% 0/236 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.	2.8% 4/144 • 24 months The analysis of safety was based on the as-treated cohort of 380 total patients (88 non-randomized SECURE-C patients, 148 randomized SECURE-C patients, and 144 ACDF patients). The control ACDF group includes 140 patients randomized to ACDF, 3 patients randomized to SECURE-C who received ACDF, and 1 patient from the non-randomized cohort who received ACDF. The Clinical Events Committee (CEC) classified each adverse event.

Additional Information

Jacqueline Myer

Globus Medical

Phone: 610-930-1800

Email: jmyer@globusmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee To prevent premature disclosure of information, Investigators agree not to present, publish, or disclose study results or information about the Investigational Device without the express written consent of Sponsor.
• Publication restrictions are in place

Restriction type: OTHER