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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291018
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : March 8, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Symptomatic Cervical Disc Disease
Interventions Device: Total Disc Replacement
Device: ACDF
Enrollment 368
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group Anterior Cervical Discectomy and Fusion ACDF Randomized Group 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
Period Title: Overall Study
Started 103 [1] 106 [2] 136 [3]
Evaluated at 24 Months 99 92 105
Completed 78 [4] 64 [4] 93 [4]
Not Completed 25 42 43
Reason Not Completed
Not Consented or Declined PAS             12             15             15
Death             3             3             4
Withdrawal by Subject             2             8             1
Failures             5             12             5
Lost to Follow-up             3             4             18
[1]
Enrolled and Treated. 111 PDC subjects were Enrolled but only 103 were Treated.
[2]
Enrolled and Treated. 117 ACDF subjects were Enrolled but only 106 were Treated.
[3]
Enrolled and Treated. 140 PDC-CA subjects were Enrolled but only 136 were Treated.
[4]
Evaluated at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access Total
Hide Arm/Group Description ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Anterior Cervical Discectomy and Fusion ACDF Randomized 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 of all reporting groups
Overall Number of Baseline Participants 103 106 136 345
Hide Baseline Analysis Population Description
Number of subjects enrolled and treated
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 106 participants 136 participants 345 participants
42.1  (8.42) 43.5  (7.15) 43.4  (7.95) 43.1  (7.86)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 106 participants 136 participants 345 participants
Female
57
  55.3%
57
  53.8%
78
  57.4%
192
  55.7%
Male
46
  44.7%
49
  46.2%
58
  42.6%
153
  44.3%
[1]
Measure Description: number of subjects who are female or male
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 106 participants 136 participants 345 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   4.9%
0
   0.0%
5
   3.7%
10
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   3.9%
1
   0.9%
0
   0.0%
5
   1.4%
White
88
  85.4%
97
  91.5%
125
  91.9%
310
  89.9%
More than one race
3
   2.9%
5
   4.7%
2
   1.5%
10
   2.9%
Unknown or Not Reported
3
   2.9%
3
   2.8%
4
   2.9%
10
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants 106 participants 136 participants 345 participants
103 106 136 345
Smoking Status  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 103 participants 106 participants 136 participants 345 participants
Never 51 49 79 179
Former 18 20 30 68
Current 34 37 27 98
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 103 participants 106 participants 136 participants 345 participants
26.4  (5.32) 27.3  (5.54) 26.6  (5.07) 26.8  (5.29)
Duration of Neck/Arm Pain  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 103 participants 106 participants 136 participants 345 participants
< 6 weeks 3 3 1 7
6 weeks to 1 year 44 44 49 137
> 1 year 56 59 86 201
1.Primary Outcome
Title Overall Success
Hide Description 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
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with data at 84 months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized
Anterior Cervical Discectomy and Fusion ACDF Randomized
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 Number of Participants Analyzed 86 79 102
Measure Type: Number
Unit of Measure: % of Subjects
62.8 53.2 62.7
2.Secondary Outcome
Title Neurologic Success
Hide Description % 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)
Time Frame 84 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were "per protocol" excluding device failures
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 77 64 93
Measure Type: Number
Unit of Measure: % of Subjects
87.0 89.1 93.5
3.Secondary Outcome
Title NDI
Hide Description

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
Time Frame 84 months
Hide Outcome Measure Data
Hide Analysis Population Description
Completed the NDI Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 64 93
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (greater than 20% change) 84.6 84.4 81.7
Improvement (3% to 20% change) 9.0 9.4 9.7
No Change (-3% to 3% change) 1.3 0.0 3.2
Deterioration (less than -3% change) 5.1 6.3 5.4
4.Secondary Outcome
Title SF-36 Physical Composite Score (PCS)
Hide Description

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.

Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the SF-36 questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 62 90
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (>15% change) 78.2 74.2 68.9
Improvement (3% to 15% change) 7.7 16.1 11.1
No Change (-3% to 3% change) 2.6 3.2 2.2
Deterioration (less than -3% change) 11.5 6.5 17.8
5.Secondary Outcome
Title SF-36 Mental Composite Score (MCS)
Hide Description

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.

Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the SF-36 questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 62 90
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (>15% change) 52.6 50.0 54.4
Improvement (3% to 15% change) 19.2 22.6 21.1
No Change (-3% to 3% change) 9.0 3.2 5.6
Deterioration (less than -3% change) 19.2 24.2 18.9
6.Secondary Outcome
Title VAS Satisfaction
Hide Description 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.
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the VAS Satisfaction Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 64 93
Mean (Standard Deviation)
86.16  (23.750) 82.09  (29.331) 86.51  (23.531)
7.Secondary Outcome
Title VAS Neck Pain Intensity
Hide Description 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.
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 62 93
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (more than -20mm change) 76.9 72.6 78.5
Improvement (-3mm to -20mm change) 10.3 14.5 17.2
No Change (-3mm to 3mm change) 5.1 4.8 2.2
Deterioration (more than 3mm) 7.7 8.1 2.2
8.Secondary Outcome
Title VAS Neck Pain Frequency
Hide Description 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.
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 62 93
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (more than -20mm change) 78.2 74.2 73.1
Improvement (-3mm to -20mm change) 10.3 11.3 12.9
No Change (-3mm to 3mm change) 9.0 3.2 3.2
Deterioration (more than 3mm) 2.6 11.3 10.8
9.Secondary Outcome
Title VAS Arm Pain Intensity
Hide Description 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.
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 62 93
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (more than -20mm change) 66.7 74.2 68.8
Improvement (-3mm to -20mm change) 16.7 9.7 15.1
No Change (-3mm to 3mm change) 7.7 4.8 6.5
Deterioration (more than 3mm) 9.0 11.3 9.7
10.Secondary Outcome
Title VAS Arm Pain Frequency
Hide Description 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.
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 61 93
Measure Type: Number
Unit of Measure: % of Subjects
Significant Improvement (more than -20mm change) 61.5 75.4 66.7
Improvement (-3mm to -20mm change) 21.8 8.2 15.1
No Change (-3mm to 3mm change) 10.3 8.2 7.5
Deterioration (more than 3mm) 6.4 8.2 10.8
11.Secondary Outcome
Title Surgery Again
Hide Description % of subjects who would opt to have the surgery again if given the choice at 84 months
Time Frame 84 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed this questionnaire at 84 months
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group
Anterior Cervical Discectomy and Fusion ACDF Randomized Group
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 Number of Participants Analyzed 78 64 92
Measure Type: Number
Unit of Measure: % of Subjects
Yes 92.3 81.3 91.3
Maybe 6.4 14.1 7.6
No 1.3 4.7 1.1
Time Frame 84 Months (i.e. 7 years)
Adverse Event Reporting Description All adverse events were captured from time of consent through the end of study (i.e. 84 Months)
 
Arm/Group Title ProDisc-C Control ProDisc-C Continued Access
Hide Arm/Group Description ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group Anterior Cervical Discectomy and Fusion ACDF Randomized Group 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
All-Cause Mortality
ProDisc-C Control ProDisc-C Continued Access
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
ProDisc-C Control ProDisc-C Continued Access
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/103 (43.69%)      53/106 (50.00%)      58/136 (42.65%)    
Cardiac disorders       
Cardiovascular  1  3/103 (2.91%)  3 3/106 (2.83%)  3 3/136 (2.21%)  4
Gastrointestinal disorders       
Gastrointestinal  1  2/103 (1.94%)  2 5/106 (4.72%)  6 2/136 (1.47%)  2
General disorders       
Death  1  3/103 (2.91%)  3 3/106 (2.83%)  3 4/136 (2.94%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer  1  4/103 (3.88%)  4 0/106 (0.00%)  0 1/136 (0.74%)  1
Nervous system disorders       
Pain - Back and Lower Extremities  1  6/103 (5.83%)  7 2/106 (1.89%)  2 4/136 (2.94%)  6
Pain - Shoulder  1  5/103 (4.85%)  8 4/106 (3.77%)  4 7/136 (5.15%)  9
Pain - Back  1  4/103 (3.88%)  4 3/106 (2.83%)  4 5/136 (3.68%)  7
Pain - Neck and Upper Extremities  1  2/103 (1.94%)  2 5/106 (4.72%)  9 2/136 (1.47%)  2
Pain - Neck  1  1/103 (0.97%)  1 3/106 (2.83%)  3 4/136 (2.94%)  5
Pain - Other  1  3/103 (2.91%)  3 1/106 (0.94%)  1 3/136 (2.21%)  4
Renal and urinary disorders       
Genitourinary  1  1/103 (0.97%)  1 1/106 (0.94%)  1 4/136 (2.94%)  4
Surgical and medical procedures       
Surgery - Index Level  1 [1]  2/103 (1.94%)  2 10/106 (9.43%)  10 1/136 (0.74%)  1
Surgery - Other  1 [2]  21/103 (20.39%)  27 27/106 (25.47%)  37 18/136 (13.24%)  29
Indicates events were collected by systematic assessment
1
Term from vocabulary, Syncode
[1]
Surgery at the original index level of the cervical spine
[2]
Surgery not at the index (cervical level)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ProDisc-C Control ProDisc-C Continued Access
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/103 (95.15%)      100/106 (94.34%)      121/136 (88.97%)    
Cardiac disorders       
Cardiovascular  1  9/103 (8.74%)  11 11/106 (10.38%)  12 12/136 (8.82%)  13
Gastrointestinal disorders       
Gastrointestinal  1  19/103 (18.45%)  25 19/106 (17.92%)  24 14/136 (10.29%)  20
General disorders       
Other  1  19/103 (18.45%)  24 18/106 (16.98%)  24 21/136 (15.44%)  31
Insomnia  1  8/103 (7.77%)  8 3/106 (2.83%)  3 3/136 (2.21%)  3
Infections and infestations       
Infection - Other Non-Wound Related  1  6/103 (5.83%)  7 11/106 (10.38%)  11 6/136 (4.41%)  6
Musculoskeletal and connective tissue disorders       
Musculoskeletal  1  34/103 (33.01%)  45 22/106 (20.75%)  31 39/136 (28.68%)  58
Musculoskeletal Spasms - Neck  1  5/103 (4.85%)  5 6/106 (5.66%)  6 12/136 (8.82%)  12
Nervous system disorders       
Pain - Neck  1  35/103 (33.98%)  43 41/106 (38.68%)  62 59/136 (43.38%)  86
Headaches  1  27/103 (26.21%)  30 21/106 (19.81%)  23 31/136 (22.79%)  36
Pain - Back  1  26/103 (25.24%)  31 22/106 (20.75%)  28 32/136 (23.53%)  57
Pain - Shoulder  1  20/103 (19.42%)  27 22/106 (20.75%)  24 33/136 (24.26%)  46
Pain - Upper Extremities  1  20/103 (19.42%)  27 15/106 (14.15%)  20 34/136 (25.00%)  43
Numbness Non-Index Level Related  1  18/103 (17.48%)  21 15/106 (14.15%)  17 22/136 (16.18%)  25
Pain - Back and Lower Extremities  1  18/103 (17.48%)  33 9/106 (8.49%)  12 14/136 (10.29%)  17
Pain - Other  1  15/103 (14.56%)  26 17/106 (16.04%)  19 20/136 (14.71%)  23
Dysphagia  1  11/103 (10.68%)  11 13/106 (12.26%)  13 15/136 (11.03%)  19
Pain - Neck and Upper Extremities with Numbness  1  10/103 (9.71%)  10 10/106 (9.43%)  17 6/136 (4.41%)  7
Pain - Neck and Shoulder  1  8/103 (7.77%)  9 10/106 (9.43%)  10 8/136 (5.88%)  8
Pain - Neck and Upper Extremities  1  7/103 (6.80%)  7 22/106 (20.75%)  30 20/136 (14.71%)  25
Pain - Upper Extremities with Numbness  1  6/103 (5.83%)  7 11/106 (10.38%)  11 11/136 (8.09%)  17
Psychiatric disorders       
Neurological  1  19/103 (18.45%)  26 15/106 (14.15%)  16 29/136 (21.32%)  39
Psychological  1  5/103 (4.85%)  5 11/106 (10.38%)  12 9/136 (6.62%)  11
Renal and urinary disorders       
Genitourinary  1  8/103 (7.77%)  8 5/106 (4.72%)  6 11/136 (8.09%)  11
Respiratory, thoracic and mediastinal disorders       
Respiratory  1  7/103 (6.80%)  8 6/106 (5.66%)  6 6/136 (4.41%)  7
Surgical and medical procedures       
Surgery - Other  1 [1]  23/103 (22.33%)  30 29/106 (27.36%)  39 24/136 (17.65%)  41
Surgery - Index Level  1 [2]  2/103 (1.94%)  2 10/106 (9.43%)  10 1/136 (0.74%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Syncode
[1]
Surgery not at the index (cervical) level
[2]
Surgery at the index level (cervical)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Erin Prifogle
Organization: DePuy Synthes Spine
Phone: 508-977-6451
EMail: eprifog1@its.jnj.com
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Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00291018    
Other Study ID Numbers: PDC-08122003
First Submitted: February 10, 2006
First Posted: February 13, 2006
Results First Submitted: November 17, 2016
Results First Posted: March 8, 2017
Last Update Posted: November 20, 2017