Age>18 years
Scheduled 1 or 2-level ACDF spine surgery
The capacity to provide informed consent.
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudoarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis
Patients with current or recent history of malignancy or infectious disease.
The inability to provide informed consent.
Subject has marked local inflammation
Subject has any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
Subject has a bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices.
Subject has bone abnormalities preventing safe screw fixation.
Subject has any open wounds.
Subject has rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis. Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
Subject has a documented or suspected metal sensitivity.
Subject is pregnant.
Subject has anatomical structures or physiological performance that would interfere with implant utilization.
Subject has inadequate tissue coverage over the operative site.
Subject has other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
Note: The Aviator Anterior Cervical Plating System is not approved or intended for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The surgeon must consider the levels of implantation, patient weight, patient activity level, and other patient conditions which may impact on the performance of the system.

NCT03077204_inc_T1
Person
Age
NCT03077204_inc_T2
Value
>18 years
NCT03077204_inc_T3
Qualifier
2-level
NCT03077204_inc_T4
Qualifier
level
NCT03077204_inc_T5
Procedure
ACDF spine surgery
NCT03077204_inc_T6
Scope
1 or 2-level
NCT03077204_inc_T8
Condition
Degenerative Disc Disease
NCT03077204_inc_T9
Condition
neck pain
NCT03077204_inc_T10
Qualifier
discogenic origin
NCT03077204_inc_T11
Condition
degeneration of the disc
NCT03077204_inc_T12
Observation
patient history
NCT03077204_inc_T13
Procedure
radiographic studies
NCT03077204_inc_T14
Condition
Trauma
NCT03077204_inc_T15
Condition
fractures
NCT03077204_inc_T16
Condition
Tumors
NCT03077204_inc_T17
Condition
Deformities
NCT03077204_inc_T18
Condition
curvatures
NCT03077204_inc_T19
Condition
kyphosis
NCT03077204_inc_T20
Condition
lordosis
NCT03077204_inc_T21
Condition
scoliosis
NCT03077204_inc_T22
Scope
kyphosis, lordosis, or scoliosis
NCT03077204_inc_T23
Scope
Deformities or curvatures
NCT03077204_inc_T24
Condition
Pseudoarthrosis
NCT03077204_inc_T25
Procedure
fusion
NCT03077204_inc_T26
Qualifier
Failed
NCT03077204_inc_T27
Temporal
previous
NCT03077204_inc_T28
Procedure
Decompression of the spinal cord
NCT03077204_inc_T29
Procedure
partial cervical vertebrectomy
NCT03077204_inc_T30
Procedure
parti vertebrectomy
Spondylo
NCT03077204_inc_T31
Scope
total or partial cervical vertebrectomy
NCT03077204_inc_T32
Condition
Spondylolisthesis
NCT03077204_inc_T34
Temporal
recent
NCT03077204_inc_T35
Temporal
current
NCT03077204_inc_T36
Observation
history
NCT03077204_inc_T37
Condition
malignancy
NCT03077204_inc_T38
Condition
infectious disease
NCT03077204_inc_T33
Condition
Spinal stenosis
NCT03077204_inc_T40
Condition
local inflammation
NCT03077204_inc_T41
Qualifier
marked
NCT03077204_inc_T42
Condition
muscul would cr
NCT03077204_inc_T43
Condition
neuromuscular disorder
NCT03077204_inc_T44
Condition
fixation failure
NCT03077204_inc_T45
Qualifier
unacceptable
NCT03077204_inc_T46
Condition
complications
NCT03077204_inc_T47
Mood
risk of
NCT03077204_inc_T48
Scope
fixation failure or complications
NCT03077204_inc_T49
Scope
mental or neuromuscular disorder
NCT03077204_inc_T50
Condition
bone stock compromised
NCT03077204_inc_T51
Condition
disease
NCT03077204_inc_T52
Condition
infection
NCT03077204_inc_T53
Procedure
implantation
NCT03077204_inc_T54
Temporal
prior
NCT03077204_inc_T55
Observation
adequate support
NCT03077204_inc_T56
Procedure
fixation to the devices
NCT03077204_inc_T57
Measurement
cannot
NCT03077204_inc_T58
Scope
adequate support and/or fixation to the devices
NCT03077204_inc_T59
Scope
disease, infection or prior implantation which cannot provide adequate support and/or fixation to the devices
NCT03077204_inc_T60
Condition
bone abnormalities
NCT03077204_inc_T61
Procedure
screw fixation
NCT03077204_inc_T62
Negation
preventing
NCT03077204_inc_T63
Qualifier
safe
NCT03077204_inc_T64
Scope
preventing safe screw fixation
NCT03077204_inc_T65
Condition
rapid joint disease
NCT03077204_inc_T66
Condition
bone absorption
NCT03077204_inc_T67
Condition
osteopenia
NCT03077204_inc_T68
Condition
osteomalacia
NCT03077204_inc_T69
Condition
osteoporosis
NCT03077204_inc_T70
Condition
Osteoporosis
NCT03077204_inc_T71
Condition
osteopenia
NCT03077204_inc_T72
Condition
contraindications
NCT03077204_inc_T73
Qualifier
relative
NCT03077204_inc_T74
Condition
sensitivity
NCT03077204_inc_T75
Device
metal
NCT03077204_inc_T76
Mood
documented
NCT03077204_inc_T77
Mood
suspected
NCT03077204_inc_T78
Scope
documented or suspected
NCT03077204_inc_T79
Condition
pregnant
NCT03077204_inc_T80
Observation
anatomical structures
NCT03077204_inc_T81
Observation
physiological performance
NCT03077204_inc_T82
Observation
 utilization as inadequa
NCT03077204_inc_T83
Device
implant
NCT03077204_inc_T84
Scope
anatomical structures or physiological performance
NCT03077204_inc_T85
Condition
inadequate tissue coverage
NCT03077204_inc_T86
Qualifier
operative site
NCT03077204_inc_T87
Condition
surgical conditions
NCT03077204_inc_T88
Condition
itions reclude th
NCT03077204_inc_T89
Negation
preclude
NCT03077204_inc_T90
Procedure
surgery
NCT03077204_inc_T91
Condition
congenital abnormalities
NCT03077204_inc_T92
Condition
immunosuppressive disease
NCT03077204_inc_T93
Value
elevation
NCT03077204_inc_T94
Measurement
sedimentation rate
NCT03077204_inc_T95
Qualifier
unexplained by other diseases
NCT03077204_inc_T96
Value
elevation
NCT03077204_inc_T97
Measurement
white blood count (WBC)
NCT03077204_inc_T98
Value
left shift
NCT03077204_inc_T99
Measurement
WBC differential count
NCT03077204_inc_T101
Condition
open wounds