Trial Outcomes & Findings for LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE (NCT NCT00389597)
NCT ID: NCT00389597
Last Updated: 2017-12-11
Results Overview
An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: * Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of \>= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of \<30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. * No study failures due to secondary surgical interventions at the index level * Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
599 participants
Primary outcome timeframe
2 Years
Results posted on
2017-12-11
Participant Flow
One Level TDR Arm: 169 subjects randomized (5 not operated) One Level ACDF Arm: 87 subjects randomized (6 not operated) Two level TDR arm: 232 subjects randomized (7 not operated). Two Level ACDF Arm: 115 subjects randomized (10 not operated)
1 level TDR enrolled 184 incl15 training cases (2 withdrew consent, 1 AE, 2 other). 1 level ACDF enrolled 87 with no training cases (4 withdrew consent, 2 other) for 245 randomized subjects. 2 level TDR enrolled 241 incl. 9 training cases (1 withdrew consent, 6 other); 2 Level ACDF enrolled 115 with no training cases (4 withdrew consent, 6 other)
Participant milestones
| Measure |
1 Level TDR
Cervical artificial disc (investigational device) at 1 level
|
1 Level ACDF
1 level control procedure (ACDF)
|
2 Level TDR
Cervical artificial disc (investigational device) at 2 levels
|
2 Level ACDF
2 level control procedure (ACDF)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
81
|
225
|
105
|
|
Overall Study
24 mo
|
156
|
75
|
221
|
99
|
|
Overall Study
COMPLETED
|
156
|
75
|
221
|
99
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
4
|
6
|
Reasons for withdrawal
| Measure |
1 Level TDR
Cervical artificial disc (investigational device) at 1 level
|
1 Level ACDF
1 level control procedure (ACDF)
|
2 Level TDR
Cervical artificial disc (investigational device) at 2 levels
|
2 Level ACDF
2 level control procedure (ACDF)
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
4
|
6
|
Baseline Characteristics
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Baseline characteristics by cohort
| Measure |
1 Level TDR
n=164 Participants
Cervical artificial disc (investigational device) at 1 level
|
1 Level ACDF
n=81 Participants
1 level control procedure (ACDF)
|
2 Level TDR
n=225 Participants
Cervical artificial disc (investigational device) at 2 levels
|
2 Level ACDF
n=105 Participants
2 level control procedure (ACDF)
|
Total
n=575 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
161 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
564 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
288 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
81 participants
n=7 Participants
|
225 participants
n=5 Participants
|
105 participants
n=4 Participants
|
575 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: includes study failures, per protocol, that are carried forward for overall success
An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: * Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of \>= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of \<30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. * No study failures due to secondary surgical interventions at the index level * Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC
Outcome measures
| Measure |
1 Level ACDF
n=75 Participants
control procedure (ACDF) at one level
|
1 Level TDR
n=156 Participants
Cervical artificial disc (investigational device) at 1 level
|
2 Level ACDF
n=99 Participants
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
|
2 Level TDR
n=221 Participants
control procedure (ACDF) at two levels
|
|---|---|---|---|---|
|
Composite Definition of Study Success
|
65.3 percentage of subjects analyzed
|
73.7 percentage of subjects analyzed
|
37.4 percentage of subjects analyzed
|
69.7 percentage of subjects analyzed
|
Adverse Events
1 Level TDR Arm
Serious events: 32 serious events
Other events: 170 other events
Deaths: 0 deaths
1 Level ACDF Arm
Serious events: 21 serious events
Other events: 75 other events
Deaths: 0 deaths
2 Level TDR Arm
Serious events: 56 serious events
Other events: 209 other events
Deaths: 0 deaths
2 Level ACDF Arm
Serious events: 34 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Level TDR Arm
n=179 participants at risk
Cervical artificial disc (investigational device) at 1 level
|
1 Level ACDF Arm
n=81 participants at risk
|
2 Level TDR Arm
n=234 participants at risk
Cervical artificial disc (investigational device) at 2 levels
|
2 Level ACDF Arm
n=105 participants at risk
|
|---|---|---|---|---|
|
Nervous system disorders
Upper Extremity Nerve Entrapment
|
1.7%
3/179 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.7%
4/234 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Skin and subcutaneous tissue disorders
Wound Issue - Non-infection
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.5%
2/81 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.85%
2/234 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.9%
3/105 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.56%
1/179 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Surgical and medical procedures
Anatomy/Technical Difficulty
|
0.56%
1/179 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Cardiac disorders
Cardiovascular
|
2.2%
4/179 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
3.0%
7/234 • Number of events 9 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
General disorders
Death
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia/Dysphonia
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.85%
2/234 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.9%
2/105 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.8%
5/179 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.3%
3/234 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.9%
2/105 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
0.56%
1/179 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/234 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Infections and infestations
Infection
|
1.7%
3/179 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.9%
4/81 • Number of events 6 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.6%
6/234 • Number of events 9 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.9%
3/105 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Surgical and medical procedures
Malpositioned implant
|
0.56%
1/179 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Neck and/or Arm Pain
|
1.7%
3/179 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.5%
2/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.3%
10/234 • Number of events 15 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
5.7%
6/105 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Nervous system disorders
Neurological
|
2.8%
5/179 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
3.7%
3/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.1%
5/234 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.8%
5/105 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Non-union
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
6.2%
5/81 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
10.5%
11/105 • Number of events 14 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
General disorders
Other
|
3.4%
6/179 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
5.1%
12/234 • Number of events 14 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
8.6%
9/105 • Number of events 13 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Other pain
|
3.4%
6/179 • Number of events 7 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.9%
4/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.3%
10/234 • Number of events 15 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.9%
3/105 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
1.1%
2/179 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.3%
3/234 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
1.7%
3/179 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
8.6%
7/81 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.7%
4/234 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
6.7%
7/105 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Social circumstances
Trauma
|
2.2%
4/179 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
6.2%
5/81 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
3.0%
7/234 • Number of events 10 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.9%
2/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Renal and urinary disorders
Urogenital
|
1.1%
2/179 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
Other adverse events
| Measure |
1 Level TDR Arm
n=179 participants at risk
Cervical artificial disc (investigational device) at 1 level
|
1 Level ACDF Arm
n=81 participants at risk
|
2 Level TDR Arm
n=234 participants at risk
Cervical artificial disc (investigational device) at 2 levels
|
2 Level ACDF Arm
n=105 participants at risk
|
|---|---|---|---|---|
|
Surgical and medical procedures
Anatomy/Techical Difficulty
|
6.1%
11/179 • Number of events 12 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.5%
2/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
3.8%
9/234 • Number of events 9 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.8%
5/105 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.2%
4/179 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.3%
3/234 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Cardiac disorders
Cardiovascular
|
11.2%
20/179 • Number of events 26 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
12.3%
10/81 • Number of events 10 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
9.0%
21/234 • Number of events 29 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
9.5%
10/105 • Number of events 12 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
General disorders
Death
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia/Dysphonia
|
11.2%
20/179 • Number of events 26 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
21.0%
17/81 • Number of events 20 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
16.7%
39/234 • Number of events 43 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
22.9%
24/105 • Number of events 27 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Gastrointestinal disorders
Gastrointestinal
|
21.8%
39/179 • Number of events 60 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
18.5%
15/81 • Number of events 37 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
20.1%
47/234 • Number of events 97 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
30.5%
32/105 • Number of events 52 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
5.0%
9/179 • Number of events 10 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.9%
4/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.6%
6/234 • Number of events 6 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Infections and infestations
Infection
|
18.4%
33/179 • Number of events 51 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
24.7%
20/81 • Number of events 28 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
23.9%
56/234 • Number of events 98 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
28.6%
30/105 • Number of events 50 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Surgical and medical procedures
Malpositioned Implant
|
1.1%
2/179 • Number of events 2 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.2%
1/81 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.7%
4/234 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/105 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Neck and/or Arm Pain
|
56.4%
101/179 • Number of events 212 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
58.0%
47/81 • Number of events 98 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
43.6%
102/234 • Number of events 167 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
60.0%
63/105 • Number of events 111 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Nervous system disorders
Neurological
|
67.6%
121/179 • Number of events 401 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
64.2%
52/81 • Number of events 215 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
53.0%
124/234 • Number of events 426 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
74.3%
78/105 • Number of events 278 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Non-Union
|
0.00%
0/179 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.9%
4/81 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.43%
1/234 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
12.4%
13/105 • Number of events 18 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
General disorders
Other
|
43.0%
77/179 • Number of events 114 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
40.7%
33/81 • Number of events 66 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
42.3%
99/234 • Number of events 189 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
55.2%
58/105 • Number of events 104 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Other Pain
|
57.0%
102/179 • Number of events 226 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
58.0%
47/81 • Number of events 144 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
56.0%
131/234 • Number of events 267 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
61.0%
64/105 • Number of events 132 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
3.4%
6/179 • Number of events 6 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
7.4%
6/81 • Number of events 8 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
8.1%
19/234 • Number of events 29 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
10.5%
11/105 • Number of events 12 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
3.4%
6/179 • Number of events 7 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
12.3%
10/81 • Number of events 12 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
5.6%
13/234 • Number of events 18 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
12.4%
13/105 • Number of events 20 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Social circumstances
Trauma
|
26.3%
47/179 • Number of events 70 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
24.7%
20/81 • Number of events 38 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
22.2%
52/234 • Number of events 89 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
19.0%
20/105 • Number of events 36 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Nervous system disorders
Upper Extremity Nerve Entrapment
|
4.5%
8/179 • Number of events 9 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
4.9%
4/81 • Number of events 5 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
5.6%
13/234 • Number of events 16 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
5.7%
6/105 • Number of events 7 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Renal and urinary disorders
Urogenital
|
5.0%
9/179 • Number of events 11 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
11.1%
9/81 • Number of events 12 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
6.4%
15/234 • Number of events 23 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
9.5%
10/105 • Number of events 14 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Vascular disorders
Vascular Intraoperative
|
0.56%
1/179 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/81 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.00%
0/234 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
0.95%
1/105 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
|
Skin and subcutaneous tissue disorders
Wound Issue -- Non-Infection
|
0.56%
1/179 • Number of events 1 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
3.7%
3/81 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
1.7%
4/234 • Number of events 4 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
2.9%
3/105 • Number of events 3 • 24 months
Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
|
Additional Information
Noah Bartsch, VP, Clinical,Regulatory,Quality
LDR Spine
Phone: 512-344-3319
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical site must submit to the Company, for review, any manuscripts, papers, summaries, abstracts, outlines or other media for publication at least 60 days before disclosure for the Company to review. The company has 30 days to review the proposed publication for any patentable subject matter or designated confidential information or confidential health information and by written notice to the site/PI identify such text so that the Company has time to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER