Trial Outcomes & Findings for Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD (NCT NCT00291018)

Last Updated: 2017-11-20

Results Overview

Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material

Recruitment status

COMPLETED

Study phase

Target enrollment

368 participants

Primary outcome timeframe

84 Months

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	ProDisc-C ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group	Control Anterior Cervical Discectomy and Fusion ACDF Randomized Group	ProDisc-C Continued Access ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
Overall Study STARTED	103	106	136
Overall Study Evaluated at 24 Months	99	92	105
Overall Study COMPLETED	78	64	93
Overall Study NOT COMPLETED	25	42	43

Reasons for withdrawal

Reasons for withdrawal
Measure	ProDisc-C ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group	Control Anterior Cervical Discectomy and Fusion ACDF Randomized Group	ProDisc-C Continued Access ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
Overall Study Not Consented or Declined PAS	12	15	15
Overall Study Death	3	3	4
Overall Study Withdrawal by Subject	2	8	1
Overall Study Failures	5	12	5
Overall Study Lost to Follow-up	3	4	18

Baseline Characteristics

Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProDisc-C n=103 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=106 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=136 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized	Total n=345 Participants Total of all reporting groups
Age, Continuous	42.1 Years STANDARD_DEVIATION 8.42 • n=5 Participants	43.5 Years STANDARD_DEVIATION 7.15 • n=7 Participants	43.4 Years STANDARD_DEVIATION 7.95 • n=5 Participants	43.1 Years STANDARD_DEVIATION 7.86 • n=4 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	57 Participants n=7 Participants	78 Participants n=5 Participants	192 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	49 Participants n=7 Participants	58 Participants n=5 Participants	153 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	97 Participants n=7 Participants	125 Participants n=5 Participants	310 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	103 Participants n=5 Participants	106 Participants n=7 Participants	136 Participants n=5 Participants	345 Participants n=4 Participants
Smoking Status Never	51 Subjects n=5 Participants	49 Subjects n=7 Participants	79 Subjects n=5 Participants	179 Subjects n=4 Participants
Smoking Status Former	18 Subjects n=5 Participants	20 Subjects n=7 Participants	30 Subjects n=5 Participants	68 Subjects n=4 Participants
Smoking Status Current	34 Subjects n=5 Participants	37 Subjects n=7 Participants	27 Subjects n=5 Participants	98 Subjects n=4 Participants
BMI	26.4 kg/m^2 STANDARD_DEVIATION 5.32 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 5.54 • n=7 Participants	26.6 kg/m^2 STANDARD_DEVIATION 5.07 • n=5 Participants	26.8 kg/m^2 STANDARD_DEVIATION 5.29 • n=4 Participants
Duration of Neck/Arm Pain < 6 weeks	3 Subjects n=5 Participants	3 Subjects n=7 Participants	1 Subjects n=5 Participants	7 Subjects n=4 Participants
Duration of Neck/Arm Pain 6 weeks to 1 year	44 Subjects n=5 Participants	44 Subjects n=7 Participants	49 Subjects n=5 Participants	137 Subjects n=4 Participants
Duration of Neck/Arm Pain > 1 year	56 Subjects n=5 Participants	59 Subjects n=7 Participants	86 Subjects n=5 Participants	201 Subjects n=4 Participants

PRIMARY outcome

Timeframe: 84 Months

Population: Subjects with data at 84 months

Outcome measures

Outcome measures
Measure	ProDisc-C n=86 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=79 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=102 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
Overall Success	62.8 % of Subjects	53.2 % of Subjects	62.7 % of Subjects

SECONDARY outcome

Timeframe: 84 months

Population: Subjects who were "per protocol" excluding device failures

% of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value)

Outcome measures

Outcome measures
Measure	ProDisc-C n=77 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=64 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
Neurologic Success	87.0 % of Subjects	89.1 % of Subjects	93.5 % of Subjects

SECONDARY outcome

Timeframe: 84 months

Population: Completed the NDI Questionnaire at 84 Months

NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation. Mean duration of the test is 3-8 minutes and the results can be interpreted as: * 0-4 points (0-8%) no disability; * 5-14 points (10-28%) mild disability; * 15-24 points (30-48%) moderate disability; * 25-34 points (50-64%) severe disability; * 35-50 points (70-100%) complete disability

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=64 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
NDI Significant Improvement (greater than 20% change)	84.6 % of Subjects	84.4 % of Subjects	81.7 % of Subjects
NDI Improvement (3% to 20% change)	9.0 % of Subjects	9.4 % of Subjects	9.7 % of Subjects
NDI No Change (-3% to 3% change)	1.3 % of Subjects	0.0 % of Subjects	3.2 % of Subjects
NDI Deterioration (less than -3% change)	5.1 % of Subjects	6.3 % of Subjects	5.4 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the SF-36 questionnaire at 84 Months

The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=62 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=90 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
SF-36 Physical Composite Score (PCS) Significant Improvement (>15% change)	78.2 % of Subjects	74.2 % of Subjects	68.9 % of Subjects
SF-36 Physical Composite Score (PCS) Improvement (3% to 15% change)	7.7 % of Subjects	16.1 % of Subjects	11.1 % of Subjects
SF-36 Physical Composite Score (PCS) No Change (-3% to 3% change)	2.6 % of Subjects	3.2 % of Subjects	2.2 % of Subjects
SF-36 Physical Composite Score (PCS) Deterioration (less than -3% change)	11.5 % of Subjects	6.5 % of Subjects	17.8 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the SF-36 questionnaire at 84 Months

The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=62 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=90 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
SF-36 Mental Composite Score (MCS) Significant Improvement (>15% change)	52.6 % of Subjects	50.0 % of Subjects	54.4 % of Subjects
SF-36 Mental Composite Score (MCS) Improvement (3% to 15% change)	19.2 % of Subjects	22.6 % of Subjects	21.1 % of Subjects
SF-36 Mental Composite Score (MCS) No Change (-3% to 3% change)	9.0 % of Subjects	3.2 % of Subjects	5.6 % of Subjects
SF-36 Mental Composite Score (MCS) Deterioration (less than -3% change)	19.2 % of Subjects	24.2 % of Subjects	18.9 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the VAS Satisfaction Questionnaire at 84 Months

The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction \[with the surgery/outcome\]" at 0mm and "Complete Satisfaction \[with the surgery/outcome\]" at 100mm.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=64 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
VAS Satisfaction	86.16 (MEAN) Standard Deviation 23.750	82.09 (MEAN) Standard Deviation 29.331	86.51 (MEAN) Standard Deviation 23.531

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months

The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \[Neck\] Pain" at 0mm and "Worst \[Neck\] Pain Possible" at 100mm.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=62 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
VAS Neck Pain Intensity Significant Improvement (more than -20mm change)	76.9 % of Subjects	72.6 % of Subjects	78.5 % of Subjects
VAS Neck Pain Intensity Improvement (-3mm to -20mm change)	10.3 % of Subjects	14.5 % of Subjects	17.2 % of Subjects
VAS Neck Pain Intensity No Change (-3mm to 3mm change)	5.1 % of Subjects	4.8 % of Subjects	2.2 % of Subjects
VAS Neck Pain Intensity Deterioration (more than 3mm)	7.7 % of Subjects	8.1 % of Subjects	2.2 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months

The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \[Neck\] Pain" at 0mm and "All of the Time \[Neck\] Pain" at 100mm.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=62 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
VAS Neck Pain Frequency Significant Improvement (more than -20mm change)	78.2 % of Subjects	74.2 % of Subjects	73.1 % of Subjects
VAS Neck Pain Frequency Improvement (-3mm to -20mm change)	10.3 % of Subjects	11.3 % of Subjects	12.9 % of Subjects
VAS Neck Pain Frequency No Change (-3mm to 3mm change)	9.0 % of Subjects	3.2 % of Subjects	3.2 % of Subjects
VAS Neck Pain Frequency Deterioration (more than 3mm)	2.6 % of Subjects	11.3 % of Subjects	10.8 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months

The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No \[Arm\] Pain" at 0mm and "Worst \[Arm\] Pain Possible" at 100mm.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=62 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
VAS Arm Pain Intensity Significant Improvement (more than -20mm change)	66.7 % of Subjects	74.2 % of Subjects	68.8 % of Subjects
VAS Arm Pain Intensity Improvement (-3mm to -20mm change)	16.7 % of Subjects	9.7 % of Subjects	15.1 % of Subjects
VAS Arm Pain Intensity No Change (-3mm to 3mm change)	7.7 % of Subjects	4.8 % of Subjects	6.5 % of Subjects
VAS Arm Pain Intensity Deterioration (more than 3mm)	9.0 % of Subjects	11.3 % of Subjects	9.7 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months

The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time \[Arm\] Pain" at 0mm and "All of the Time \[Arm\] Pain" at 100mm.

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=61 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=93 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
VAS Arm Pain Frequency Significant Improvement (more than -20mm change)	61.5 % of Subjects	75.4 % of Subjects	66.7 % of Subjects
VAS Arm Pain Frequency Improvement (-3mm to -20mm change)	21.8 % of Subjects	8.2 % of Subjects	15.1 % of Subjects
VAS Arm Pain Frequency No Change (-3mm to 3mm change)	10.3 % of Subjects	8.2 % of Subjects	7.5 % of Subjects
VAS Arm Pain Frequency Deterioration (more than 3mm)	6.4 % of Subjects	8.2 % of Subjects	10.8 % of Subjects

SECONDARY outcome

Timeframe: 84 Months

Population: Subjects who completed this questionnaire at 84 months

% of subjects who would opt to have the surgery again if given the choice at 84 months

Outcome measures

Outcome measures
Measure	ProDisc-C n=78 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized	Control n=64 Participants Anterior Cervical Discectomy and Fusion ACDF Randomized	ProDisc-C Continued Access n=92 Participants ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized
Surgery Again No	1.3 % of Subjects	4.7 % of Subjects	1.1 % of Subjects
Surgery Again Yes	92.3 % of Subjects	81.3 % of Subjects	91.3 % of Subjects
Surgery Again Maybe	6.4 % of Subjects	14.1 % of Subjects	7.6 % of Subjects

Adverse Events

ProDisc-C

Serious events: 45 serious events

Other events: 98 other events

Deaths: 0 deaths

Control

Serious events: 53 serious events

Other events: 100 other events

Deaths: 0 deaths

ProDisc-C Continued Access

Serious events: 58 serious events

Other events: 121 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ProDisc-C n=103 participants at risk ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group	Control n=106 participants at risk Anterior Cervical Discectomy and Fusion ACDF Randomized Group	ProDisc-C Continued Access n=136 participants at risk ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
Nervous system disorders Pain - Back and Lower Extremities	5.8% 6/103 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	1.9% 2/106 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.9% 4/136 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Shoulder	4.9% 5/103 • Number of events 8 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	3.8% 4/106 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	5.1% 7/136 • Number of events 9 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Surgical and medical procedures Surgery - Index Level	1.9% 2/103 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	9.4% 10/106 • Number of events 10 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.74% 1/136 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Surgical and medical procedures Surgery - Other	20.4% 21/103 • Number of events 27 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	25.5% 27/106 • Number of events 37 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	13.2% 18/136 • Number of events 29 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Gastrointestinal disorders Gastrointestinal	1.9% 2/103 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.7% 5/106 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	1.5% 2/136 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	3.9% 4/103 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.00% 0/106 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.74% 1/136 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Back	3.9% 4/103 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.8% 3/106 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	3.7% 5/136 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Neck and Upper Extremities	1.9% 2/103 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.7% 5/106 • Number of events 9 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	1.5% 2/136 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Renal and urinary disorders Genitourinary	0.97% 1/103 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.94% 1/106 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.9% 4/136 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
General disorders Death	2.9% 3/103 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.8% 3/106 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.9% 4/136 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Neck	0.97% 1/103 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.8% 3/106 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.9% 4/136 • Number of events 5 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Other	2.9% 3/103 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.94% 1/106 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.2% 3/136 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Cardiac disorders Cardiovascular	2.9% 3/103 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.8% 3/106 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.2% 3/136 • Number of events 4 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)

Other adverse events

Additional Information

Erin Prifogle

DePuy Synthes Spine

Phone: 508-977-6451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	ProDisc-C n=103 participants at risk ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group	Control n=106 participants at risk Anterior Cervical Discectomy and Fusion ACDF Randomized Group	ProDisc-C Continued Access n=136 participants at risk ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group
Nervous system disorders Pain - Neck	34.0% 35/103 • Number of events 43 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	38.7% 41/106 • Number of events 62 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	43.4% 59/136 • Number of events 86 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Musculoskeletal and connective tissue disorders Musculoskeletal	33.0% 34/103 • Number of events 45 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	20.8% 22/106 • Number of events 31 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	28.7% 39/136 • Number of events 58 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Headaches	26.2% 27/103 • Number of events 30 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	19.8% 21/106 • Number of events 23 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	22.8% 31/136 • Number of events 36 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Back	25.2% 26/103 • Number of events 31 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	20.8% 22/106 • Number of events 28 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	23.5% 32/136 • Number of events 57 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Surgical and medical procedures Surgery - Other	22.3% 23/103 • Number of events 30 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	27.4% 29/106 • Number of events 39 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	17.6% 24/136 • Number of events 41 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Shoulder	19.4% 20/103 • Number of events 27 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	20.8% 22/106 • Number of events 24 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	24.3% 33/136 • Number of events 46 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Upper Extremities	19.4% 20/103 • Number of events 27 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	14.2% 15/106 • Number of events 20 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	25.0% 34/136 • Number of events 43 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Gastrointestinal disorders Gastrointestinal	18.4% 19/103 • Number of events 25 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	17.9% 19/106 • Number of events 24 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.3% 14/136 • Number of events 20 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Psychiatric disorders Neurological	18.4% 19/103 • Number of events 26 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	14.2% 15/106 • Number of events 16 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	21.3% 29/136 • Number of events 39 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
General disorders Other	18.4% 19/103 • Number of events 24 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	17.0% 18/106 • Number of events 24 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	15.4% 21/136 • Number of events 31 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Numbness Non-Index Level Related	17.5% 18/103 • Number of events 21 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	14.2% 15/106 • Number of events 17 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	16.2% 22/136 • Number of events 25 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Back and Lower Extremities	17.5% 18/103 • Number of events 33 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	8.5% 9/106 • Number of events 12 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.3% 14/136 • Number of events 17 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Other	14.6% 15/103 • Number of events 26 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	16.0% 17/106 • Number of events 19 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	14.7% 20/136 • Number of events 23 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Dysphagia	10.7% 11/103 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	12.3% 13/106 • Number of events 13 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	11.0% 15/136 • Number of events 19 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Neck and Upper Extremities with Numbness	9.7% 10/103 • Number of events 10 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	9.4% 10/106 • Number of events 17 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.4% 6/136 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Cardiac disorders Cardiovascular	8.7% 9/103 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.4% 11/106 • Number of events 12 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	8.8% 12/136 • Number of events 13 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Renal and urinary disorders Genitourinary	7.8% 8/103 • Number of events 8 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.7% 5/106 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	8.1% 11/136 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
General disorders Insomnia	7.8% 8/103 • Number of events 8 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.8% 3/106 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	2.2% 3/136 • Number of events 3 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Neck and Shoulder	7.8% 8/103 • Number of events 9 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	9.4% 10/106 • Number of events 10 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	5.9% 8/136 • Number of events 8 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Neck and Upper Extremities	6.8% 7/103 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	20.8% 22/106 • Number of events 30 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	14.7% 20/136 • Number of events 25 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Respiratory, thoracic and mediastinal disorders Respiratory	6.8% 7/103 • Number of events 8 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	5.7% 6/106 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.4% 6/136 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Infections and infestations Infection - Other Non-Wound Related	5.8% 6/103 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.4% 11/106 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	4.4% 6/136 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Nervous system disorders Pain - Upper Extremities with Numbness	5.8% 6/103 • Number of events 7 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.4% 11/106 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	8.1% 11/136 • Number of events 17 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Musculoskeletal and connective tissue disorders Musculoskeletal Spasms - Neck	4.9% 5/103 • Number of events 5 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	5.7% 6/106 • Number of events 6 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	8.8% 12/136 • Number of events 12 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Psychiatric disorders Psychological	4.9% 5/103 • Number of events 5 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	10.4% 11/106 • Number of events 12 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	6.6% 9/136 • Number of events 11 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
Surgical and medical procedures Surgery - Index Level	1.9% 2/103 • Number of events 2 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	9.4% 10/106 • Number of events 10 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)	0.74% 1/136 • Number of events 1 • 84 Months (i.e. 7 years) All adverse events were captured from time of consent through the end of study (i.e. 84 Months)