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Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

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ClinicalTrials.gov Identifier: NCT00432159
Recruitment Status : Completed
First Posted : February 7, 2007
Results First Posted : August 7, 2014
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
DePuy Spine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cervical Degenerative Disc Disease
Interventions Device: Cervical TDR
Device: ACDF with plate
Enrollment 500
Recruitment Details First subject was enrolled on July 10, 2006. The final study subjects were enrolled on March 22, 2011 and all study sites were informed that enrollment was closed effective March 31, 2011.
Pre-assignment Details  
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Period Title: Overall Study
Started 185 167 39 20 89
Completed 163 [1] 137 [1] 35 [1] 15 [1] 79 [1]
Not Completed 22 30 4 5 10
Reason Not Completed
Death             0             1             0             0             0
Failure             9             5             3             2             3
Missing NDI and/or neuro. assessment             13             24             1             3             7
[1]
Actual (Complete efficacy)
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR Total
Hide Arm/Group Description Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Total of all reporting groups
Overall Number of Baseline Participants 185 167 39 20 89 500
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 167 participants 39 participants 20 participants 89 participants 500 participants
44.2  (8.63) 42.8  (7.63) 44.1  (7.94) 44.4  (7.74) 42.3  (7.49) 43.4  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 167 participants 39 participants 20 participants 89 participants 500 participants
Female
93
  50.3%
89
  53.3%
26
  66.7%
10
  50.0%
42
  47.2%
260
  52.0%
Male
92
  49.7%
78
  46.7%
13
  33.3%
10
  50.0%
47
  52.8%
240
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 167 participants 39 participants 20 participants 89 participants 500 participants
Hispanic or Latino
7
   3.8%
4
   2.4%
1
   2.6%
1
   5.0%
1
   1.1%
14
   2.8%
Not Hispanic or Latino
172
  93.0%
153
  91.6%
38
  97.4%
19
  95.0%
88
  98.9%
470
  94.0%
Unknown or Not Reported
6
   3.2%
10
   6.0%
0
   0.0%
0
   0.0%
0
   0.0%
16
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 167 participants 39 participants 20 participants 89 participants 500 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
1
   1.1%
2
   0.4%
Asian
1
   0.5%
2
   1.2%
1
   2.6%
0
   0.0%
1
   1.1%
5
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   4.3%
6
   3.6%
1
   2.6%
2
  10.0%
4
   4.5%
21
   4.2%
White
170
  91.9%
147
  88.0%
36
  92.3%
18
  90.0%
82
  92.1%
453
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
1
   0.2%
Unknown or Not Reported
6
   3.2%
11
   6.6%
1
   2.6%
0
   0.0%
0
   0.0%
18
   3.6%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 185 participants 167 participants 39 participants 20 participants 89 participants 500 participants
28.3  (4.97) 27.6  (4.83) 28.3  (4.97) 30.0  (3.61) 28.9  (5.12) 28.3  (4.9)
[1]
Measure Description: Body Mass Index in units of kilogram per meter squared
1.Primary Outcome
Title Overall Success
Hide Description Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 169 133 38 17 82
Measure Type: Number
Unit of Measure: participants who are successes
137 110 28 13 65
2.Secondary Outcome
Title NDI Success
Hide Description 15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 161 127 35 15 78
Measure Type: Number
Unit of Measure: participants who are successes
139 111 29 13 67
3.Secondary Outcome
Title Neurological Component of Success
Hide Description no new clinically significant permanent abnormalities in neurological function
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 162 129 35 15 80
Measure Type: Number
Unit of Measure: participants who are successes
161 127 35 15 77
4.Secondary Outcome
Title Subsequent Secondary Surgery Component of Success
Hide Description no subsequent secondary surgical intervention at the index level
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 185 167 39 20 89
Measure Type: Number
Unit of Measure: participants who are successes
176 160 35 18 84
5.Secondary Outcome
Title Device-Related SAE Component of Success
Hide Description no device related serious adverse events
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 185 167 39 20 89
Measure Type: Number
Unit of Measure: participants who are successes
184 167 39 20 89
6.Secondary Outcome
Title NDI - Change From Baseline
Hide Description Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 161 127 35 15 78
Mean (Standard Deviation)
Unit of Measure: NDI Score
-33.4  (17.97) -33.2  (18.04) -32.8  (20.62) -32.9  (22.10) -34.3  (21.00)
7.Secondary Outcome
Title Neck Pain VAS Scores - Change From Baseline
Hide Description Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 124 35 15 78
Mean (Standard Error)
Unit of Measure: Units on a scale
-47.0  (30.43) -41.5  (30.57) -36.1  (33.15) -27.2  (26.14) -46.3  (33.60)
8.Secondary Outcome
Title Maximum Arm Pain VAS - Change From Baseline
Hide Description Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 123 35 15 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-52.0  (32.69) -49.5  (33.45) -42.4  (37.54) -30.9  (44.62) -44.3  (35.61)
9.Secondary Outcome
Title Average Arm Pain VAS - Change From Baseline
Hide Description Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 123 35 15 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-32.1  (25.62) -28.8  (20.88) -30.5  (25.90) -20.6  (26.33) -26.6  (24.70)
10.Secondary Outcome
Title Maximum Shoulder Pain VAS - Change From Baseline
Hide Description Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 123 35 15 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-52.1  (31.96) -47.9  (30.18) -43.0  (34.74) -21.4  (43.84) -45.9  (38.13)
11.Secondary Outcome
Title Average Shoulder Pain VAS - Change From Baseline
Hide Description Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 123 35 15 78
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-34.1  (26.45) -31.6  (22.69) -31.7  (30.36) -15.6  (24.85) -31.0  (29.12)
12.Secondary Outcome
Title Dysphagia Disability Index - Change From Baseline
Hide Description Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as “always” 4, “sometimes” 2, or “never” 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 154 117 35 15 77
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.3  (7.91) 0.7  (7.22) 0.3  (10.19) 1.2  (5.89) -0.8  (9.56)
13.Secondary Outcome
Title SF-36 - Physical Composite Scores (PCS) - Change From Baseline
Hide Description Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 160 127 35 15 79
Mean (Standard Deviation)
Unit of Measure: Units on a scale
14.2  (10.66) 13.3  (10.50) 15.2  (9.23) 6.6  (10.18) 15.2  (10.73)
14.Secondary Outcome
Title SF-36 - Mental Composite Scores (MCS) - Change From Baseline
Hide Description Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 160 127 35 15 79
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.2  (11.66) 8.8  (12.01) 6.3  (12.89) 12.2  (13.65) 6.3  (13.19)
15.Secondary Outcome
Title Work Status Assessment
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 167 131 38 16 83
Measure Type: Number
Unit of Measure: participants
Not Working 28 18 6 2 11
Full Time 111 91 21 12 61
Part Time 12 10 2 2 7
Full or Part Time 123 101 23 14 68
Total 151 119 29 16 79
Not Applicable 16 12 9 0 4
16.Secondary Outcome
Title Return to Work
Hide Description Estimated Proportion of Subjects Returning to Work
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 172 157 31 20 85
Measure Type: Number
Unit of Measure: % of subjects who returned to work
87 86 84 90 92
17.Secondary Outcome
Title Activity
Hide Description Clinical Assessment of Activity
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 162 129 35 15 80
Measure Type: Number
Unit of Measure: participants
Light 39 30 11 5 21
Moderate 79 58 17 8 37
Vigorous 44 41 7 2 22
18.Secondary Outcome
Title Subject Satisfaction
Hide Description Subject Satisfaction (Would you have this procedure again?)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 185 167 39 20 89
Measure Type: Number
Unit of Measure: participants
Definitely Yes 121 86 24 8 62
Probably Yes 25 32 5 4 9
Unsure or Too Early to Tell 10 6 3 2 4
Probably Not 4 3 3 2 3
Definitely Not 1 2 2 0 0
19.Secondary Outcome
Title Global Cervical Range of Motion - Change From Baseline
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Overall Number of Participants Analyzed 147 117 35 15 66
Mean (Standard Deviation)
Unit of Measure: degrees
5.4  (16.14) -2.8  (14.67) 3.0  (14.88) -14.4  (13.21) 2.1  (15.36)
20.Secondary Outcome
Title Average Radiographic Disc Height (mm) - Change From Post-op
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate
Hide Arm/Group Description:
Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Overall Number of Participants Analyzed 153 114
Mean (Standard Deviation)
Unit of Measure: mm
-1.0  (0.76) -1.0  (0.83)
Time Frame 24 months. Safety data is still being collected on all DISCOVER subjects through 60 months.
Adverse Event Reporting Description The population used in the adverse event tables is "As Treated". One subject was randomized to control, but was treated with DISCOVER. This explains why the denominators in the adverse event tables are 186 and 166 for the randomized one level cohorts.
 
Arm/Group Title 1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Hide Arm/Group Description Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc. Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate. Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
All-Cause Mortality
1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/186 (31.72%)      44/166 (26.51%)      14/39 (35.90%)      5/20 (25.00%)      24/89 (26.97%)    
Blood and lymphatic system disorders           
Lymphadenitis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Cardiac disorders           
Acute myocardial infarction  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Angina pectoris  1  4/186 (2.15%)  6 1/166 (0.60%)  1 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Angina unstable  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Cardiac arrest  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Coronary artery stenosis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Myocardial infarction  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 1/20 (5.00%)  2 0/89 (0.00%)  0
Palpitations  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Ear and labyrinth disorders           
Eustachian tube dysfunction  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Eye disorders           
Conjunctivitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Eye pain  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Visual disturbance  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gastrointestinal disorders           
Abdominal distension  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Abdominal pain  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Abdominal pain lower  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Abdominal pain upper  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Colitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Dysphagia  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Nausea  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Oesophageal varices haemorrhage  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Small intestinal obstruction  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Umbilical hernia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Vomiting  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
General disorders           
Adverse drug reaction  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Chest pain  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Death  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Impaired healing  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Local swelling  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Non-cardiac chest pain  1  4/186 (2.15%)  4 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Surgical failure  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Hepatobiliary disorders           
Biliary colic  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Cholecystitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Infections and infestations           
Appendicitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Bronchopneumonia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Catheter related infection  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Cellulitis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Diverticulitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gastroenteritis viral  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Pneumonia  1  2/186 (1.08%)  2 2/166 (1.20%)  2 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Postoperative wound infection  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Upper respiratory tract infection  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Wound infection  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Injury, poisoning and procedural complications           
Alcohol poisoning  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Ankle fracture  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Burns third degree  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  2 0/20 (0.00%)  0 0/89 (0.00%)  0
Collapse of lung  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Complication of device removal  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Concussion  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Device malfunction  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Device migration  1  2/186 (1.08%)  2 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 3/89 (3.37%)  3
Drug toxicity  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Dural tear  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Foreign body trauma  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gun shot wound  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Incisional hernia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Lower limb fracture  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Meniscus lesion  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Multiple fractures  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pneumothorax traumatic  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Procedural hypotension  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Procedural pain  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Renal injury  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Surgical procedure repeated  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Tendon rupture  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Wrist fracture  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Investigations           
Spinal X-ray abnormal  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  1/186 (0.54%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Hyperglycaemia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Obesity  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  4/186 (2.15%)  5 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Back pain  1  6/186 (3.23%)  7 3/166 (1.81%)  4 2/39 (5.13%)  2 0/20 (0.00%)  0 3/89 (3.37%)  3
Cervical spinal stenosis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Extraskeletal ossification  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Facet joint syndrome  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Fracture nonunion  1  1/186 (0.54%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Intervertebral disc degeneration  1  2/186 (1.08%)  2 3/166 (1.81%)  3 2/39 (5.13%)  2 1/20 (5.00%)  1 3/89 (3.37%)  3
Intervertebral disc disorder  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Intervertebral disc protrusion  1  6/186 (3.23%)  6 2/166 (1.20%)  2 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Lumbar spinal stenosis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Muscular weakness  1  0/186 (0.00%)  0 1/166 (0.60%)  1 1/39 (2.56%)  2 0/20 (0.00%)  0 0/89 (0.00%)  0
Musculoskeletal chest pain  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Musculoskeletal pain  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Myalgia  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Neck pain  1  3/186 (1.61%)  3 6/166 (3.61%)  7 1/39 (2.56%)  1 1/20 (5.00%)  1 4/89 (4.49%)  4
Osteoarthritis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Osteonecrosis  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pain in extremity  1  3/186 (1.61%)  3 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Rotator cuff syndrome  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Spinal osteoarthritis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Spondylitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Spondylolisthesis  1  2/186 (1.08%)  3 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Sympathetic posterior cervical syndrome  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Synovial cyst  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bile duct cancer  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Breast cancer  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Neuroma  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Prostate cancer  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Thyroid neoplasm  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Uterine leiomyoma  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Vulval cancer recurrent  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Nervous system disorders           
Cerebrovascular accident  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Cervicobrachial syndrome  1  2/186 (1.08%)  2 1/166 (0.60%)  1 1/39 (2.56%)  1 0/20 (0.00%)  0 2/89 (2.25%)  2
Convulsion  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Intracranial hypotension  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Lumbar radiculopathy  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Paraesthesia  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Presyncope  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Radicular pain  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Radiculitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Sciatica  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Subarachnoid haemorrhage  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Thoracic outlet syndrome  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Delivery  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Psychiatric disorders           
Psychotic disorder  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Urinary incontinence  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Urinary retention  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Reproductive system and breast disorders           
Cystocele  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Menorrhagia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Ovarian cyst  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Uterine haemorrhage  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Uterovaginal prolapse  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Nasal congestion  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pharyngeal oedema  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  2 0/20 (0.00%)  0 0/89 (0.00%)  0
Pneumonia aspiration  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Skin and subcutaneous tissue disorders           
Subcutaneous emphysema  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Vascular disorders           
Aortic aneurysm  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pelvic venous thrombosis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1-level Cervical TDR 1-level ACDF With Plate 2-level Cervical TDR 2-level ACDF Training: 1 & 2-level Cervical TDR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/186 (84.95%)      135/166 (81.33%)      38/39 (97.44%)      20/20 (100.00%)      83/89 (93.26%)    
Blood and lymphatic system disorders           
Lymphoid tissue hyperplasia  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Cardiac disorders           
Bradyarrhythmia  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Palpitations  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Tachycardia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Congenital, familial and genetic disorders           
Myotonia congenita  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Ear and labyrinth disorders           
Ear pain  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Eustachian tube dysfunction  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Tinnitus  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Vertigo  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Endocrine disorders           
Hypothyroidism  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Pituitary cyst  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Eye disorders           
Glaucoma  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Optic neuropathy  1  0/186 (0.00%)  0 1/166 (0.60%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Vision blurred  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Coeliac disease  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Constipation  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 1/20 (5.00%)  1 0/89 (0.00%)  0
Crohn's disease  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Defaecation urgency  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Diarrhoea  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Duodenitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Dyspepsia  1  0/186 (0.00%)  0 2/166 (1.20%)  2 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Dysphagia  1  12/186 (6.45%)  12 19/166 (11.45%)  19 8/39 (20.51%)  8 2/20 (10.00%)  2 6/89 (6.74%)  7
Gastric ulcer  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Gastritis  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gastrooesophageal reflux disease  1  1/186 (0.54%)  1 4/166 (2.41%)  4 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Gingival disorder  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Irritable bowel syndrome  1  0/186 (0.00%)  0 1/166 (0.60%)  1 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Malignant dysphagia  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Nausea  1  4/186 (2.15%)  4 2/166 (1.20%)  2 0/39 (0.00%)  0 1/20 (5.00%)  1 3/89 (3.37%)  3
Oesophagitis  1  1/186 (0.54%)  1 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Oral disorder  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Paraesthesia oral  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Salivary gland calculus  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Stomach discomfort  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Tongue disorder  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Tooth loss  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Umbilical hernia  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Vomiting  1  3/186 (1.61%)  3 2/166 (1.20%)  2 0/39 (0.00%)  0 1/20 (5.00%)  1 6/89 (6.74%)  7
General disorders           
Adverse drug reaction  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Asthenia  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Chest discomfort  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Chest pain  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Discomfort  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Drug intolerance  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Drug withdrawal syndrome  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Feeling abnormal  1  0/186 (0.00%)  0 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Feeling cold  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gait disturbance  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Influenza like illness  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Local swelling  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 2/20 (10.00%)  2 0/89 (0.00%)  0
Localised oedema  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Non-cardiac chest pain  1  2/186 (1.08%)  2 1/166 (0.60%)  1 1/39 (2.56%)  1 0/20 (0.00%)  0 1/89 (1.12%)  1
Oedema peripheral  1  2/186 (1.08%)  4 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Pain  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  2
Pyrexia  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 1/20 (5.00%)  1 1/89 (1.12%)  1
Sensation of foreign body  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Cholelithiasis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Immune system disorders           
Drug hypersensitivity  1  1/186 (0.54%)  1 1/166 (0.60%)  1 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Hypersensitivity  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Sarcoidosis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Infections and infestations           
Appendicitis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Bronchitis  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 1/20 (5.00%)  1 1/89 (1.12%)  1
Diarrhoea infectious  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Diverticulitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Folliculitis  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gastroenteritis viral  1  2/186 (1.08%)  2 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Hepatitis C  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Herpes zoster  1  1/186 (0.54%)  1 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Incision site infection  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Influenza  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  2
Laryngitis  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Lobar pneumonia  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Nasopharyngitis  1  0/186 (0.00%)  0 2/166 (1.20%)  2 2/39 (5.13%)  2 0/20 (0.00%)  0 1/89 (1.12%)  1
Pharyngitis  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Pharyngitis streptococcal  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Pneumonia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Postoperative wound infection  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Purulent discharge  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Sinusitis  1  4/186 (2.15%)  4 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 3/89 (3.37%)  3
Skin graft infection  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Staphylococcal infection  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Staphylococcal skin infection  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Stitch abscess  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Upper respiratory tract infection  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Urinary tract infection  1  1/186 (0.54%)  1 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Viral infection  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Wound infection  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Injury, poisoning and procedural complications           
Accidental overdose  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Airway complication of anaesthesia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Animal bite  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Ankle fracture  1  3/186 (1.61%)  3 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Back injury  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Cervical vertebral fracture  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Concussion  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Contrast media reaction  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Contusion  1  3/186 (1.61%)  3 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 1/89 (1.12%)  1
Corneal abrasion  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Device breakage  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Device migration  1  2/186 (1.08%)  3 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 3/89 (3.37%)  3
Dural tear  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Epicondylitis  1  1/186 (0.54%)  1 3/166 (1.81%)  4 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  2
Facial bones fracture  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Fall  1  0/186 (0.00%)  0 2/166 (1.20%)  2 1/39 (2.56%)  1 0/20 (0.00%)  0 1/89 (1.12%)  1
Foot fracture  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Foreign body in eye  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Fractured sacrum  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Hand fracture  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Incision site complication  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Incision site erythema  1  1/186 (0.54%)  1 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Incision site haematoma  1  1/186 (0.54%)  1 2/166 (1.20%)  2 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Incision site oedema  1  2/186 (1.08%)  2 0/166 (0.00%)  0 2/39 (5.13%)  2 0/20 (0.00%)  0 0/89 (0.00%)  0
Incision site pain  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Incisional hernia  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Joint dislocation  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Joint injury  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Joint sprain  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  2
Ligament rupture  1  2/186 (1.08%)  2 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Limb injury  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 1/20 (5.00%)  1 0/89 (0.00%)  0
Limb traumatic amputation  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Meniscus lesion  1  5/186 (2.69%)  5 1/166 (0.60%)  1 0/39 (0.00%)  0 1/20 (5.00%)  1 1/89 (1.12%)  1
Muscle injury  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Muscle strain  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Neck injury  1  0/186 (0.00%)  0 2/166 (1.20%)  2 1/39 (2.56%)  1 1/20 (5.00%)  1 3/89 (3.37%)  3
Nerve injury  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Post laminectomy syndrome  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Post lumbar puncture syndrome  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Post procedural haematoma  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Post-traumatic pain  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  4
Postoperative fever  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Procedural headache  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Procedural nausea  1  2/186 (1.08%)  2 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Procedural pain  1  4/186 (2.15%)  7 2/166 (1.20%)  2 1/39 (2.56%)  1 0/20 (0.00%)  0 1/89 (1.12%)  1
Procedural vomiting  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Radius fracture  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Road traffic accident  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  3
Skin laceration  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Suture rupture  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Tendon rupture  1  0/186 (0.00%)  0 2/166 (1.20%)  2 1/39 (2.56%)  1 1/20 (5.00%)  1 0/89 (0.00%)  0
Urinary retention postoperative  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Whiplash injury  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 2/89 (2.25%)  2
Wound  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Investigations           
Blood cholesterol increased  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Blood creatine phosphokinase increased  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Blood glucose increased  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
CSF pressure increased  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Grip strength decreased  1  0/186 (0.00%)  0 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 1/89 (1.12%)  1
Heart rate irregular  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Nuclear magnetic resonance imaging brain abnormal  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Weight decreased  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Weight increased  1  0/186 (0.00%)  0 0/166 (0.00%)  0 1/39 (2.56%)  1 0/20 (0.00%)  0 0/89 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/186 (0.00%)  0 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Diabetes mellitus  1  2/186 (1.08%)  2 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Gout  1  1/186 (0.54%)  1 0/166 (0.00%)  0 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Hypercholesterolaemia  1  1/186 (0.54%)  1 1/166 (0.60%)  1 0/39 (0.00%)  0 0/20 (0.00%)  0 0/89 (0.00%)  0
Type 2 diabetes mellitus  1  2/186 (1.08%)  2 0/166 (0.00%)  0 2/39 (5.13%)  2 0/20 (0.00%)  0 1/89 (1.12%)  1
Vitamin D deficiency  1  0/186 (0.00%)  0 1/166 (0.60%)  1