Trial Outcomes & Findings for Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease (NCT NCT00589797)
NCT ID: NCT00589797
Last Updated: 2018-12-07
Results Overview
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
376 participants
Primary outcome timeframe
24 months
Results posted on
2018-12-07
Participant Flow
Subjects were screened and enrolled at 19 US health care center sites
Participant milestones
| Measure |
Investigational
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Overall Study
STARTED
|
264
|
112
|
|
Overall Study
Baseline
|
218
|
106
|
|
Overall Study
24 Months
|
191
|
89
|
|
Overall Study
COMPLETED
|
191
|
89
|
|
Overall Study
NOT COMPLETED
|
73
|
23
|
Reasons for withdrawal
| Measure |
Investigational
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
Physician Decision
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Non-Randomized Training Subjects
|
46
|
6
|
Baseline Characteristics
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
Baseline characteristics by cohort
| Measure |
Investigational
n=264 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=112 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
264 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
235 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Oswestry Disability Index (ODI) Scores for Low Back Pain
|
57.1 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
|
58.6 units on a scale
STANDARD_DEVIATION 14.1 • n=7 Participants
|
57.9 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Visual Analog Scale (VAS) Ratings for Back and Leg Pain
VAS Back Pain
|
79.0 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 14.8 • n=7 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Visual Analog Scale (VAS) Ratings for Back and Leg Pain
VAS Right Leg Pain
|
28.7 units on a scale
STANDARD_DEVIATION 29.8 • n=5 Participants
|
32.9 units on a scale
STANDARD_DEVIATION 29.6 • n=7 Participants
|
30.6 units on a scale
STANDARD_DEVIATION 30.0 • n=5 Participants
|
|
Visual Analog Scale (VAS) Ratings for Back and Leg Pain
VAS Left Leg Pain
|
29.6 units on a scale
STANDARD_DEVIATION 29.4 • n=5 Participants
|
30.7 units on a scale
STANDARD_DEVIATION 29.5 • n=7 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 29.6 • n=5 Participants
|
|
Short-Form (36) Health Questionnaire (SF-36) Scores
SF-36 MCS
|
39.1 units on a scale
STANDARD_DEVIATION 13.9 • n=5 Participants
|
39.6 units on a scale
STANDARD_DEVIATION 14.9 • n=7 Participants
|
39.4 units on a scale
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Short-Form (36) Health Questionnaire (SF-36) Scores
SF-36 PCS
|
29.9 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
29.2 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Rotational Range of Motion
Flexion/Extension
|
6.6 degrees
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.6 degrees
STANDARD_DEVIATION 4.6 • n=7 Participants
|
6.6 degrees
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Rotational Range of Motion
Lateral Bending AP
|
1.0 degrees
STANDARD_DEVIATION 2.0 • n=5 Participants
|
1.0 degrees
STANDARD_DEVIATION 1.8 • n=7 Participants
|
1.0 degrees
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Translational Range of Motion
|
0.5 millimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
0.6 millimeters
STANDARD_DEVIATION 0.6 • n=7 Participants
|
0.6 millimeters
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Normal Neurological Status
Motor
|
97 participants
n=5 Participants
|
40 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Normal Neurological Status
Sensory
|
78 participants
n=5 Participants
|
33 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Normal Neurological Status
Reflexes
|
91 participants
n=5 Participants
|
42 participants
n=7 Participants
|
133 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Measured by absence of treatment failure; absence or serious device related AE; maintenance or improvement of ROM at index level; maintenance or improvement of neurological status; improvement in ODI score.
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Overall Success at 24 Months Relative to Baseline
Including ROM success component
|
42.2 percentage of participants
Interval 35.6 to 49.1
|
28.3 percentage of participants
Interval 20.0 to 37.9
|
|
Overall Success at 24 Months Relative to Baseline
Without ROM success component
|
61.9 percentage of participants
Interval 55.1 to 68.4
|
52.8 percentage of participants
Interval 42.9 to 62.6
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Percent of subjects demonstrating no Subsequent Surgical Interventions (SSI's) at the index level (L4-L5 or L5-S1) at 24 months.
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Device Success
|
84.4 percentage of participants
Interval 78.9 to 89.0
|
84.9 percentage of participants
Interval 76.6 to 91.1
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Percent of subjects demonstrating no device related SAE's at 24 months as per the Clinical Events Committee (CEC)
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Absence of Serious Device Related Adverse Events
|
76.6 percentage of participants
Interval 70.4 to 82.1
|
70.8 percentage of participants
Interval 61.1 to 79.2
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Percent of subjects demonstrating maintenance or improvement in ROM at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Range of Motion (ROM) Success
|
58.7 percentage of participants
Interval 51.9 to 65.3
|
42.5 percentage of participants
Interval 32.9 to 52.4
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Percent of patients demonstrating maintenance or improvement in combined motor and sensory evaluations at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Neurological Success
|
80.3 percentage of participants
Interval 74.4 to 85.3
|
76.4 percentage of participants
Interval 67.2 to 84.1
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; missing data imputed as failures
Percent of subjects demonstrating an improvement of greater than or equal to 15 points at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=218 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
ODI Success
|
75.2 percentage of participants
Interval 68.9 to 80.8
|
66.0 percentage of participants
Interval 56.2 to 75.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; observed data (i.e. missing data not imputed as failures)
Number of patients demonstrating improvement in back and leg pain at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=180 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=84 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
VAS Success for Back and Leg Pain at Rest
VAS Rating for Back Pain
|
162 participants
|
72 participants
|
|
VAS Success for Back and Leg Pain at Rest
VAS Rating for Left Leg Pain
|
72 participants
|
35 participants
|
|
VAS Success for Back and Leg Pain at Rest
VAS Rating for Right Leg Pain
|
73 participants
|
36 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; observational data (i.e. missing data not imputed as failures)
Number of subjects demonstrating improvement in two measures of ODI success at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=187 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=87 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
ODI Success Using Two Measures of Success
Greater than or equal to 15 points of improvement
|
164 participants
|
70 participants
|
|
ODI Success Using Two Measures of Success
Greater than or equal to 15% improvement
|
170 participants
|
77 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intent to treat population; observational data (i.e. missing data not imputed as failures)
Number of subjects demonstrating a greater than or equal to 15% improvement in mental (MCS) and physical (PCS) component summary scores at 24 months compared to baseline
Outcome measures
| Measure |
Investigational
n=180 Participants
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=86 Participants
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Improvement in SF-36 Scores
SF-36 MCS
|
101 participants
|
48 participants
|
|
Improvement in SF-36 Scores
SF-36 PCS
|
156 participants
|
69 participants
|
Adverse Events
Investigational
Serious events: 86 serious events
Other events: 197 other events
Deaths: 0 deaths
Control
Serious events: 57 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational
n=218 participants at risk
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 participants at risk
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Blood and lymphatic system disorders
High Cholesterol
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Cardiac disorders
Cardiac Issues
|
2.3%
5/218 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Ear and labyrinth disorders
Eyes, Ears, Nose or Throat Issues
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Endocrine disorders
Diabetes Mellitus
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Endocrine disorders
Goiter
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Esophageal Issues
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Gastric Issues
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Intestinal Issues
|
2.3%
5/218 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
4.7%
5/106 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Other GI Issues
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Hepatobiliary disorders
Gall Bladder Issues
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Hepatobiliary disorders
Liver Fibrosis
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Immune system disorders
Fever
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Immune system disorders
Sjogren's Syndrome
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Immune system disorders
Systemic Allergic Reaction
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Infections and infestations
Systemic Infection
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Injury, poisoning and procedural complications
Trauma
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture - Lumbar
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture - Non-Lumbar
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Degenerative Joint Disease - Lumbar
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Degenerative Joint Disease - Non-Lumbar
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Joint or Muscle Issues
|
4.6%
10/218 • Number of events 11 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Non-Lumbar Radiographic Observation
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
5.7%
6/106 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Pain in Non-Lumbar or Leg
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
3.8%
4/106 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
5.0%
11/218 • Number of events 14 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
4.7%
5/106 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lower Extremity Pain
|
3.2%
7/218 • Number of events 7 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
3.8%
4/106 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar Only Pain
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
5.7%
6/106 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar and Lower Extremeties Sensory Deficit
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar and Lower Extremities Motor Deficit
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar and Lower Extremity Pain
|
4.1%
9/218 • Number of events 9 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
7.5%
8/106 • Number of events 8 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Non-Lumbar and Lower Extremities Deficit
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
3.8%
4/106 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Related Issues
|
3.2%
7/218 • Number of events 8 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Psychosocial Disorders
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Substance Related Disorders
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Suicide
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Renal and urinary disorders
Benign Prostatic Hypertrophy
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Renal and urinary disorders
Kidney Issues
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Female Reproductive System Issues
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Male Reproductive System Issues
|
2.3%
5/218 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
3.8%
4/106 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Reproductive System Related Surgeries
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Disorders
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infections
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Surgical and medical procedures
Device Deficiency
|
3.2%
7/218 • Number of events 7 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Surgical and medical procedures
Index Procedure Related Wounds
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Surgical and medical procedures
Subsequent Surgical Intervention Procedure Related Wounds
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Blood Loss
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Blood Pressure
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Embolism
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Thrombosis
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Vascular Issues
|
0.46%
1/218 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
Other adverse events
| Measure |
Investigational
n=218 participants at risk
Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1
|
Control
n=106 participants at risk
Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1.
|
|---|---|---|
|
Vascular disorders
Blood Pressure
|
4.1%
9/218 • Number of events 9 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
6.6%
7/106 • Number of events 7 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Vascular disorders
Vascular Issues
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Cardiac disorders
Cardiac Issues
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Endocrine disorders
Diabetes Mellitus
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Ear and labyrinth disorders
Eyes, Ears, Nose or Throat
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
5.7%
6/106 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Gastric Issues
|
12.4%
27/218 • Number of events 27 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
8.5%
9/106 • Number of events 10 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Gastrointestinal disorders
Intestinal Issues
|
7.3%
16/218 • Number of events 17 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
10.4%
11/106 • Number of events 13 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Related Issues
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Male Reproductive System Issues
|
3.2%
7/218 • Number of events 8 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Female Reproductive System Issues
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Reproductive system and breast disorders
Reproductive System Related Surgeries
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.00%
0/106 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Renal and urinary disorders
Urinary Issues
|
10.6%
23/218 • Number of events 24 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
6.6%
7/106 • Number of events 8 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Immune system disorders
Non-Procedure Allergic Reactions
|
1.4%
3/218 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
4.7%
5/106 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Infections and infestations
Infections
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/218 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
2.8%
3/106 • Number of events 3 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Blood and lymphatic system disorders
High Cholesterol
|
2.3%
5/218 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Degenerative Joint Disease - Lumbar
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
0.92%
2/218 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Joint or Muscle Issues
|
8.7%
19/218 • Number of events 22 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
10.4%
11/106 • Number of events 13 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Pain in Non-Lumbar or Leg
|
20.6%
45/218 • Number of events 54 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
13.2%
14/106 • Number of events 15 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Surgical and medical procedures
Non-Lumbar Radiographic Observation
|
8.7%
19/218 • Number of events 19 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
8.5%
9/106 • Number of events 9 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Lumbar and Lower Extremity Motor Deficit
|
2.8%
6/218 • Number of events 7 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
4.7%
5/106 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Lumbar and Lower Extremity Sensory Deficit
|
11.0%
24/218 • Number of events 25 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
15.1%
16/106 • Number of events 18 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Musculoskeletal and connective tissue disorders
Reflex Change or Abnormality
|
2.3%
5/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Non-Lumbar and Lower Extremity Deficit
|
8.3%
18/218 • Number of events 19 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
6.6%
7/106 • Number of events 8 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lower Extremity Pain
|
18.3%
40/218 • Number of events 45 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
10.4%
11/106 • Number of events 15 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar Only Pain
|
20.2%
44/218 • Number of events 48 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
28.3%
30/106 • Number of events 31 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Nervous system disorders
Lumbar and Lower Extremity Pain
|
19.3%
42/218 • Number of events 42 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
21.7%
23/106 • Number of events 23 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Psychosocial Disorders
|
5.5%
12/218 • Number of events 15 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
4.7%
5/106 • Number of events 5 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Substance Related Disorders
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
0.94%
1/106 • Number of events 1 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Psychiatric disorders
Sleep Disorders
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Disorders
|
2.8%
6/218 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
1.9%
2/106 • Number of events 2 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infections
|
4.6%
10/218 • Number of events 10 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
5.7%
6/106 • Number of events 6 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory Disorders
|
1.8%
4/218 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
3.8%
4/106 • Number of events 4 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Injury, poisoning and procedural complications
Trauma
|
17.4%
38/218 • Number of events 50 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
19.8%
21/106 • Number of events 27 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
|
Surgical and medical procedures
Index Procedure Related Wounds
|
7.8%
17/218 • Number of events 18 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
11.3%
12/106 • Number of events 12 • Serious and Non-Serious Adverse Events Adjudicated as of 9 October 2015
All anticipated and unanticipated serious and non-serious adverse events in the intent to treat population
|
Additional Information
Associate Director of Medical and Scientific Affairs
Aesculap Inc.
Phone: 800-258-1946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60