Trial Outcomes & Findings for Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery (NCT NCT00295009)
NCT ID: NCT00295009
Last Updated: 2014-08-06
Results Overview
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: 1. Same as above 2. Same as above 3. Same as above 4. No re-operations to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
852 participants
Primary outcome timeframe
24 Months
Results posted on
2014-08-06
Participant Flow
Participant milestones
| Measure |
1-Level Fusion
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-Randomized)
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
93
|
183
|
51
|
82
|
174
|
269
|
|
Overall Study
Treated
|
80
|
162
|
50
|
72
|
165
|
259
|
|
Overall Study
Completed 24 Month Analysis
|
71
|
148
|
45
|
60
|
133
|
198
|
|
Overall Study
COMPLETED
|
52
|
134
|
39
|
57
|
116
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
49
|
12
|
25
|
58
|
269
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
Baseline characteristics by cohort
| Measure |
1-Level Fusion
n=80 Participants
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
n=162 Participants
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-randomized)
n=50 Participants
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
n=72 Participants
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
n=165 Participants
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
n=259 Participants
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
Total
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
40.5 years
STANDARD_DEVIATION 7.4 • n=8 Participants
|
40.3 years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
358 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
156 Participants
n=8 Participants
|
430 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
162 participants
n=7 Participants
|
50 participants
n=5 Participants
|
72 participants
n=4 Participants
|
165 participants
n=21 Participants
|
259 participants
n=8 Participants
|
788 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 24 MonthsPopulation: Patients who completed all 24 month visit analyses
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: 1. Same as above 2. Same as above 3. Same as above 4. No re-operations to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Outcome measures
| Measure |
1-Level Fusion
n=71 Participants
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
n=148 Participants
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-randomized)
n=45 Participants
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
n=60 Participants
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
n=133 Participants
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
n=198 Participants
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
|---|---|---|---|---|---|---|
|
Overall Success
|
45.1 percentage of overall successes
|
63.5 percentage of overall successes
|
66.7 percentage of overall successes
|
53.3 percentage of overall successes
|
59.4 percentage of overall successes
|
58.6 percentage of overall successes
|
PRIMARY outcome
Timeframe: 60 MonthsPopulation: Patients who completed all 60 month visit analyses
Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met: 1. ODI score improved by at least 15% from baseline; 2. SF-36 score improved from baseline; 3. Neurologic parameters maintained or improved from baseline; 4. No re-operations required to modify or remove the implant; and 5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion. A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met: Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
Outcome measures
| Measure |
1-Level Fusion
n=52 Participants
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
n=134 Participants
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-randomized)
n=39 Participants
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
n=57 Participants
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
n=116 Participants
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
|---|---|---|---|---|---|---|
|
Overall Success
|
50.0 percentage of overall successes
|
53.7 percentage of overall successes
|
56.4 percentage of overall successes
|
50.9 percentage of overall successes
|
55.2 percentage of overall successes
|
—
|
Adverse Events
1-Level Fusion
Serious events: 27 serious events
Other events: 73 other events
Deaths: 0 deaths
1-Level ProDisc
Serious events: 43 serious events
Other events: 153 other events
Deaths: 0 deaths
1-Level ProDisc (Non-Randomized)
Serious events: 16 serious events
Other events: 46 other events
Deaths: 0 deaths
2-Level Fusion
Serious events: 23 serious events
Other events: 69 other events
Deaths: 0 deaths
2-Level ProDisc
Serious events: 39 serious events
Other events: 153 other events
Deaths: 0 deaths
2-Level ProDisc (Continued Access)
Serious events: 38 serious events
Other events: 219 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1-Level Fusion
n=80 participants at risk
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
n=162 participants at risk
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-Randomized)
n=50 participants at risk
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
n=72 participants at risk
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
n=165 participants at risk
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
n=259 participants at risk
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Additional Surgery Index Level
|
10.0%
8/80 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
7.4%
12/162 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.9%
5/72 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
2/165 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.5%
4/259 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Blood and lymphatic system disorders
Blood Loss
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.0%
5/165 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.5%
4/259 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Cardiac disorders
Cardiovascular
|
2.5%
2/80 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
2/162 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
2/165 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Death
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.9%
3/162 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
2/165 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/162 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.61%
1/165 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
3/259 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Infections and infestations
Infection
|
8.8%
7/80 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.7%
6/162 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.9%
5/72 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.8%
3/165 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Nervous system disorders
Neurological
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.62%
1/162 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.4%
4/165 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.39%
1/259 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain
|
2.5%
2/80 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.9%
3/162 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.61%
1/165 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.39%
1/259 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Surgical and medical procedures
Surgery - Adjacent Level
|
2.5%
2/80 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.61%
1/165 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.39%
1/259 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Surgical and medical procedures
Surgery - Other
|
15.0%
12/80 • Number of events 16 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.3%
20/162 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
14.0%
7/50 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.9%
10/72 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.5%
19/165 • Number of events 26 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.9%
18/259 • Number of events 23 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
Other adverse events
| Measure |
1-Level Fusion
n=80 participants at risk
Circumferential fusion at a single lumbar level.
|
1-Level ProDisc
n=162 participants at risk
Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
1-Level ProDisc (Non-Randomized)
n=50 participants at risk
Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
|
2-Level Fusion
n=72 participants at risk
Circumferential fusion at two adjacent lumbar levels.
|
2-Level ProDisc
n=165 participants at risk
Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
|
2-Level ProDisc (Continued Access)
n=259 participants at risk
Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
|
|---|---|---|---|---|---|---|
|
General disorders
Numbness Peripheral Nerve or Non-Index Level Related
|
11.2%
9/80 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
16.7%
27/162 • Number of events 35 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.0%
6/50 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
20.8%
15/72 • Number of events 20 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.2%
30/165 • Number of events 42 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
17.0%
44/259 • Number of events 56 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Other
|
13.8%
11/80 • Number of events 15 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.3%
20/162 • Number of events 25 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.0%
6/50 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.1%
13/72 • Number of events 19 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
16.4%
27/165 • Number of events 36 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.9%
23/259 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Back and Lower Extremities with Numbness at Index Level
|
6.2%
5/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.3%
7/162 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
3/72 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.8%
8/165 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.7%
7/259 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Back and Other
|
8.8%
7/80 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
9/162 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.9%
5/72 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.1%
15/165 • Number of events 15 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.5%
22/259 • Number of events 23 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Incision Site
|
7.5%
6/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.1%
8/72 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.5%
19/165 • Number of events 19 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.1%
21/259 • Number of events 21 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Lower Extremities
|
25.0%
20/80 • Number of events 30 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
31.5%
51/162 • Number of events 75 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
34.0%
17/50 • Number of events 26 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
41.7%
30/72 • Number of events 43 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
37.0%
61/165 • Number of events 83 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
32.8%
85/259 • Number of events 110 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Lower Extremities with Numbness at Index Level
|
2.5%
2/80 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.7%
6/162 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.3%
6/72 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.8%
8/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.8%
15/259 • Number of events 16 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Musculoskeletal and connective tissue disorders
Other Musculoskeletal
|
23.8%
19/80 • Number of events 26 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
16.0%
26/162 • Number of events 40 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
20.0%
10/50 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
15.3%
11/72 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.1%
20/165 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.6%
30/259 • Number of events 32 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Back
|
42.5%
34/80 • Number of events 48 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
52.5%
85/162 • Number of events 129 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
46.0%
23/50 • Number of events 30 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
58.3%
42/72 • Number of events 55 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
40.6%
67/165 • Number of events 97 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
32.4%
84/259 • Number of events 107 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain - Back and Lower Extremities
|
27.5%
22/80 • Number of events 25 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
27.2%
44/162 • Number of events 54 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
34.0%
17/50 • Number of events 23 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
31.9%
23/72 • Number of events 27 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
27.9%
46/165 • Number of events 63 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
16.6%
43/259 • Number of events 51 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Surgical and medical procedures
Additional Surgery Index Level
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.8%
3/165 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.9%
5/259 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
2/80 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.3%
7/162 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.1%
13/72 • Number of events 17 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.1%
10/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.6%
12/259 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Burning or Dysesthetic Pain
|
3.8%
3/80 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.9%
8/162 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.1%
10/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.9%
10/259 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Cardiac disorders
Cardiovascular
|
8.8%
7/80 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.2%
10/162 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.0%
6/50 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.3%
6/72 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.1%
15/165 • Number of events 18 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.4%
14/259 • Number of events 18 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Degenerative Disease Progression
|
6.2%
5/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
10.5%
17/162 • Number of events 20 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
7/165 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
3/259 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Degenerative Disease Progression, Other Lumbar
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.8%
11/162 • Number of events 13 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.7%
7/72 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.6%
6/165 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.7%
7/259 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
3.8%
3/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.9%
8/162 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.3%
6/72 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.0%
5/165 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.5%
9/259 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Skin and subcutaneous tissue disorders
Dermatological or Drug Allergy
|
12.5%
10/80 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.6%
22/162 • Number of events 27 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
3/72 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
2/165 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Dizziness
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
4/72 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
7/165 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.1%
8/259 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Blood and lymphatic system disorders
Edema
|
6.2%
5/80 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
7.4%
12/162 • Number of events 17 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.1%
8/72 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
7.3%
12/165 • Number of events 15 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.9%
23/259 • Number of events 27 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Fever
|
12.5%
10/80 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
7.4%
12/162 • Number of events 13 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.1%
13/72 • Number of events 15 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.8%
31/165 • Number of events 32 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.9%
36/259 • Number of events 36 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Gastrointestinal disorders
Gastrointestinal
|
31.2%
25/80 • Number of events 36 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
23.5%
38/162 • Number of events 54 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
30.0%
15/50 • Number of events 20 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
38.9%
28/72 • Number of events 49 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
40.0%
66/165 • Number of events 97 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
31.3%
81/259 • Number of events 127 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Genitourinary
|
7.5%
6/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.7%
19/162 • Number of events 21 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.0%
4/50 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.5%
9/72 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
15.2%
25/165 • Number of events 28 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.0%
31/259 • Number of events 34 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Headache
|
10.0%
8/80 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
7.4%
12/162 • Number of events 13 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
10.0%
5/50 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.9%
10/72 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.1%
15/165 • Number of events 19 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.3%
24/259 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Skin and subcutaneous tissue disorders
Incision Site Related
|
18.8%
15/80 • Number of events 16 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.2%
10/162 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/259 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Renal and urinary disorders
Incontinence
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.1%
5/162 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.4%
1/72 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.0%
5/165 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Infections and infestations
Infection - Other non-wound related
|
5.0%
4/80 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
9/162 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.0%
4/50 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
3/72 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.7%
11/165 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.0%
13/259 • Number of events 13 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Infections and infestations
Infection - Superficial Wound with Incision Site Pain
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/162 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.6%
6/165 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.9%
5/259 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Infections and infestations
Infection, Not Index Level Related
|
7.5%
6/80 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.8%
11/162 • Number of events 14 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
14.0%
7/50 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/259 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Insomnia
|
6.2%
5/80 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
9/162 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.9%
10/72 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.3%
22/165 • Number of events 23 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.7%
33/259 • Number of events 33 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Injury, poisoning and procedural complications
Migration Not Requiring Surgery
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.61%
1/165 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.39%
1/259 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal Spasms - Back
|
3.8%
3/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.5%
9/72 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.7%
21/165 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
10.4%
27/259 • Number of events 30 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Spasms - Leg
|
1.2%
1/80 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.2%
3/72 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.5%
9/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.7%
7/259 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Spasm
|
7.5%
6/80 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.0%
13/162 • Number of events 17 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.0%
3/50 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/259 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Psychiatric disorders
Neurological
|
13.8%
11/80 • Number of events 12 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
20.4%
33/162 • Number of events 46 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
14.0%
7/50 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.4%
4/165 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.39%
1/259 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Musculoskeletal and connective tissue disorders
Non-Specific Musculoskeletal Spasms
|
2.5%
2/80 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.3%
7/162 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.8%
2/72 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.8%
8/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.8%
15/259 • Number of events 16 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pain Other (Not back, hip, leg)
|
21.2%
17/80 • Number of events 20 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
28.4%
46/162 • Number of events 66 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
14.0%
7/50 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
22.2%
16/72 • Number of events 24 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
19.4%
32/165 • Number of events 38 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
14.3%
37/259 • Number of events 38 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
5/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.2%
10/162 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.0%
2/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
4/72 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
6.1%
10/165 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.4%
14/259 • Number of events 14 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Pseudoarthrosis
|
0.00%
0/80 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/162 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
5.6%
4/72 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/259 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Psychiatric disorders
Psychological
|
11.2%
9/80 • Number of events 11 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
15.4%
25/162 • Number of events 27 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
10.0%
5/50 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
16.7%
12/72 • Number of events 17 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
18.8%
31/165 • Number of events 38 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
12.4%
32/259 • Number of events 33 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
3.8%
3/80 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.9%
8/162 • Number of events 10 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.1%
8/72 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
13.3%
22/165 • Number of events 23 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.1%
21/259 • Number of events 22 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Surgical and medical procedures
Surgery - Index Level (Revision)
|
5.0%
4/80 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/162 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.7%
7/72 • Number of events 8 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.77%
2/259 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Surgical and medical procedures
Surgery - Other
|
6.2%
5/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.9%
8/162 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.0%
4/50 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
11.1%
8/72 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
20.6%
34/165 • Number of events 47 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
10.4%
27/259 • Number of events 28 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Blood and lymphatic system disorders
Vascular Injury
|
6.2%
5/80 • Number of events 6 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
3.1%
5/162 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/165 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/259 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
Blood and lymphatic system disorders
Vessel Damage/Bleeding, Minor
|
6.2%
5/80 • Number of events 5 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.5%
4/162 • Number of events 4 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/50 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.00%
0/72 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
0.61%
1/165 • Number of events 1 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
1.2%
3/259 • Number of events 3 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
|
General disorders
Wound Issues - Other
|
11.2%
9/80 • Number of events 9 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
4.3%
7/162 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
2.0%
1/50 • Number of events 2 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.3%
6/72 • Number of events 7 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
9.1%
15/165 • Number of events 17 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
8.9%
23/259 • Number of events 26 • Adverse Events were collected at each visit through 60 month follow-up
SYNCODE is a company defined medical coding category system for AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60