Trial Outcomes & Findings for PCM Cervical Disc System (NCT NCT00578812)

Last Updated: 2015-07-07

Results Overview

Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

494 participants

Primary outcome timeframe

24 Months

Results posted on

2015-07-07

Participant Flow

Each clinical site could treat up to two (2) non-randomized investigational training patients prior to entering the randomized phase of the clinical trial.

Participant milestones

Participant milestones
Measure	PCM Cervical Disc - Investigational PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Overall Study STARTED	224	192
Overall Study COMPLETED	218	185
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	PCM Cervical Disc - Investigational PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Overall Study Not treated	6	7

Baseline Characteristics

PCM Cervical Disc System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCM Cervical Disc - Investigational n=218 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=185 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Total n=403 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 9.0 • n=5 Participants	43.7 years STANDARD_DEVIATION 8.3 • n=7 Participants	44.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	89 Participants n=7 Participants	194 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	96 Participants n=7 Participants	209 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	202 participants n=5 Participants	170 participants n=7 Participants	372 participants n=5 Participants
Race/Ethnicity, Customized Black	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	218 participants n=5 Participants	185 participants n=7 Participants	403 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Per Protocol

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=189 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Individual Patient Overall Success	142 participants	98 participants

SECONDARY outcome

Timeframe: 24 Months

Population: per protocol

Improvement of ≥20mm in neck pain at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=150 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Neck Pain Visual Analog Scale	139 participants	113 participants

SECONDARY outcome

Timeframe: 24 Months

Population: per protocol

Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=150 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Mean Neck Pain Visual Analog Scale	26.1 mm Standard Deviation 28.7	30.4 mm Standard Deviation 28.3

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=150 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Worst Arm Pain Visual Analog Scale	148 participants	113 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=150 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Mean Worst Arm Pain Visual Analog Scale	24.9 mm Standard Deviation 29.2	27.5 mm Standard Deviation 28.3

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Improvement in NDI of ≥20% at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Clinically Significant Improvement on Neck Disability Index (NDI)	156 participants	123 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Improvement in NDI of ≥15-points at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Clinically Significant Improvement on Neck Disability Index (NDI)	149 participants	114 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Mean NDI at 24 months on a 0-100 scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Mean Neck Disability Index (NDI)	21.8 units on a scale Standard Deviation 22.5	25.5 units on a scale Standard Deviation 21.5

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)	133 participants	98 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Mean SF-36 Physical Component Summary (PCS)	46.6 units on a scale Standard Deviation 11.0	45.0 units on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: 24 Months

Population: Per Protocol

Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)	87 participants	75 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per Protocol

Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=187 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Mean SF-36 Mental Component Summary (MCS)	50.3 units on a scale Standard Deviation 11.1	49.3 units on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=183 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=147 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Dysphagia for Swallowing	8.8 mm Standard Deviation 16.3	12.1 mm Standard Deviation 20.1

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol

Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=182 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=146 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Patient Satisfaction	82.8 mm Standard Deviation 27.1	81.4 mm Standard Deviation 25.7

SECONDARY outcome

Timeframe: 24 Months

Population: Per protocol with extended windows

Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient "maintained" if their Nurick classification grade remained the same or "improved" if it decreased from baseline to 24 months.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=185 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=153 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Nurick's Classification of Disability (Myelopathy)	185 participants	148 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Per Protocol

Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.

Outcome measures

Outcome measures
Measure	PCM Cervical Disc-Investigational n=182 Participants PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=151 Participants Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Flexion/Extension Range of Motion at the Operative Level	5.7 degrees Standard Deviation 3.9	0.8 degrees Standard Deviation 0.8

Adverse Events

PCM Cervical Disc-Investigational

Serious events: 68 serious events

Other events: 180 other events

Deaths: 0 deaths

Anterior Cervical Discectomy and Fusion - Control Group

Serious events: 57 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Julie Pairamore, Sr. Manager, Clinical Affairs

NuVasive, Inc

Phone: 858-320-5258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators and Institutions will allow NuVasive to review and comment on any presentation or publication of any study information prior to its release to ensure such documents are accurate and do not disclose any trade secret or other confidential information. No information may be disclosed regarding the study without NuVasive's written permission.
Publication restrictions are in place

Restriction type: OTHER

Measure	PCM Cervical Disc-Investigational n=214 participants at risk PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior Cervical Discectomy and Fusion - Control Group n=190 participants at risk Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Musculoskeletal and connective tissue disorders Implant Related-Adjacent Level Disease	1.9% 4/214 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	2.1% 4/190 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Investigations Implant Related - Implant Displacement/Loosening	3.7% 8/214 • Number of events 8 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.00% 0/190 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Implant Related - Non Union	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.1% 2/190 • Number of events 3 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Injury, poisoning and procedural complications Implant Related - Spinal Event	1.4% 3/214 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.00% 0/190 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Investigations Implant Related - Subsidence	0.47% 1/214 • Number of events 1 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.00% 0/190 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Injury, poisoning and procedural complications Implant Related - Trauma	0.47% 1/214 • Number of events 1 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.53% 1/190 • Number of events 1 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Injury, poisoning and procedural complications Surgery Related - Neck/Arm Pain	0.93% 2/214 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	2.1% 4/190 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Nervous system disorders Surgery Related - Neurological	0.93% 2/214 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.6% 3/190 • Number of events 3 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Injury, poisoning and procedural complications Surgery Related - Spinal Event	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.1% 2/190 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Cardiac disorders Systemic - Cardiac Events	1.4% 3/214 • Number of events 3 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.6% 3/190 • Number of events 3 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Gastrointestinal disorders Systemic- Gastrointestinal	1.9% 4/214 • Number of events 5 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.1% 2/190 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Infections and infestations Systemic - Infection	2.3% 5/214 • Number of events 5 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.6% 3/190 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Psychiatric disorders Systemic - Mental Disorders	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.6% 3/190 • Number of events 3 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Injury, poisoning and procedural complications Systemic - Musculoskeletal Trauma	1.9% 4/214 • Number of events 4 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	4.2% 8/190 • Number of events 10 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Systemic - Musculoskeletal Adjacent Level Disease	0.47% 1/214 • Number of events 1 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.00% 0/190 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Systemic - Musculoskeletal / Back/Leg Pain	6.5% 14/214 • Number of events 18 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	2.6% 5/190 • Number of events 5 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Systemic - Musculoskeletal / Neck/Arm Pain	3.3% 7/214 • Number of events 10 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	4.2% 8/190 • Number of events 9 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Systemic - Musculoskeletal / Other	4.7% 10/214 • Number of events 10 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.1% 2/190 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Musculoskeletal and connective tissue disorders Systemic - Musculoskeletal / Spinal Event	4.7% 10/214 • Number of events 10 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	5.8% 11/190 • Number of events 11 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Nervous system disorders Systemic - Neurologic	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	1.1% 2/190 • Number of events 2 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
General disorders Systemic - Other	3.3% 7/214 • Number of events 7 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	5.8% 11/190 • Number of events 11 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Respiratory, thoracic and mediastinal disorders Systemic - Respiratory	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	0.53% 1/190 • Number of events 1 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
General disorders Systemic - Urogenital	0.00% 0/214 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).	3.2% 6/190 • Number of events 6 • Operative timepoint through 24 months. For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).