Spondylolisthesis Grade II or higher.
Subject requires uni or bilateral facetectomy to treat leg/back pain.
Subject has back or non-radicular leg pain of unknown etiology.
Prior surgery at the index lumbar level.
Subject requiring a spine DEXA (i.e., patients with SCORE of = 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.
Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
Any metabolic disease bone disease that has not been stabilized for at least three months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder, etc.).
Subject has an active infection either systemic or local.
Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.
Subject has severe arterial insufficiency of the legs (Screening on physical examination= patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other peripheral vascular disease).
Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
Subject has insulin-dependent diabetes mellitus.
Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).
Subject has been diagnosed with active hepatitis, AIDS, or HIV.
Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
Subject has a known allergy to titanium, polyethylene or polyester materials.
Subject is pregnant or interested in becoming pregnant in the next two (2) years.
Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
Subject is immunologically suppressed, received steroids >1 month over the past year.
Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
Subject has a life expectancy of less than three (3) years.
Subject is currently involved in another investigational study.
Subject is incarcerated.

NCT03366779_exc_T1
Condition
Spondylolisthesis
NCT03366779_exc_T2
Measurement
Grade
NCT03366779_exc_T3
Value
II or higher
NCT03366779_exc_T4
Qualifier
bilateral
NCT03366779_exc_T5
Procedure
facetectomy
NCT03366779_exc_T6
Qualifier
uni
NCT03366779_exc_T7
Condition
back pain
NCT03366779_exc_T8
Condition
ain. eg/
NCT03366779_exc_T9
Scope
uni or bilateral
NCT03366779_exc_T10
Scope
leg/back pain
NCT03366779_exc_T11
Condition
non-radicular leg pain
NCT03366779_exc_T12
Condition
ck o in o
NCT03366779_exc_T13
Qualifier
unknown etiology
NCT03366779_exc_T14
Scope
back or non-radicular leg pain
NCT03366779_exc_T15
Procedure
surgery
NCT03366779_exc_T16
Qualifier
index lumbar level
NCT03366779_exc_T17
Temporal
Prior
NCT03366779_exc_T18
Procedure
spine DEXA
NCT03366779_exc_T19
Measurement
SCORE
NCT03366779_exc_T20
Value
= 6
NCT03366779_exc_T21
Measurement
T Score
NCT03366779_exc_T22
Value
less than -2.0
NCT03366779_exc_T23
Qualifier
index level
NCT03366779_exc_T24
Mood
requiring
NCT03366779_exc_T25
Condition
herniation
NCT03366779_exc_T26
Qualifier
L5/S1
NCT03366779_exc_T27
Measurement
average T score
NCT03366779_exc_T28
Qualifier
L1-L4
NCT03366779_exc_T30
Scope
herniation at L5/S1
NCT03366779_exc_T31
Condition
clinically compromised vertebral bodies
NCT03366779_exc_T32
Qualifier
index level(s)
NCT03366779_exc_T33
Condition
infectious pathology
NCT03366779_exc_T34
Condition
olic, or logy.
Sub
NCT03366779_exc_T35
Condition
astic, met logy.
Sub
NCT03366779_exc_T36
Condition
atic, neo logy.
Sub
NCT03366779_exc_T37
Scope
traumatic, neoplastic, metabolic, or infectious pathology
NCT03366779_exc_T38
Condition
fractures of the vertebra
NCT03366779_exc_T39
Multiplier
multiple
NCT03366779_exc_T40
Condition
fractures of the vertebra
NCT03366779_exc_T41
Condition
res of the verte ubj
NCT03366779_exc_T42
Scope
fractures of the vertebra or hip
NCT03366779_exc_T43
Qualifier
pathologic
NCT03366779_exc_T44
Condition
scoliosis
NCT03366779_exc_T45
Qualifier
greater than ten (10) degrees
NCT03366779_exc_T46
Qualifier
angular
NCT03366779_exc_T47
Qualifier
rotational
NCT03366779_exc_T48
Scope
angular and rotational
NCT03366779_exc_T49
Condition
metabolic disease
NCT03366779_exc_T50
Observation
been stabilized
NCT03366779_exc_T51
Temporal
for at least three months
NCT03366779_exc_T52
Condition
Paget's disease
NCT03366779_exc_T53
Condition
osteomalacia
NCT03366779_exc_T54
Condition
osteogenesis imperfecta
NCT03366779_exc_T55
Condition
thyroid
NCT03366779_exc_T56
Condition
parathyroid gland disorder
NCT03366779_exc_T57
Scope
Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder
NCT03366779_exc_T58
Negation
not
NCT03366779_exc_T59
Condition
bone disease
NCT03366779_exc_T60
Scope
metabolic disease bone disease
NCT03366779_exc_T61
Condition
infection
NCT03366779_exc_T62
Qualifier
active
NCT03366779_exc_T63
Qualifier
systemic
NCT03366779_exc_T64
Qualifier
local
NCT03366779_exc_T65
Scope
systemic or local
NCT03366779_exc_T66
Condition
cauda equina syndrome
NCT03366779_exc_T67
Condition
 bowel/bladder  n.
Subject
NCT03366779_exc_T68
Condition
 bowel/bl sfunction.
Subject
NCT03366779_exc_T69
Qualifier
severe
NCT03366779_exc_T70
Condition
arterial insufficiency
NCT03366779_exc_T71
Qualifier
legs
NCT03366779_exc_T72
Condition
diminution or absence of dorsalis pedis
NCT03366779_exc_T73
Condition
or absence of dorsalis p ibialis pulses. If dimini
NCT03366779_exc_T74
Procedure
arterial ultrasound
NCT03366779_exc_T75
Procedure
vascular plethysmography
NCT03366779_exc_T76
Measurement
absolute arterial pressure
NCT03366779_exc_T77
Value
below 50mm of Hg
NCT03366779_exc_T78
Qualifier
le l  th
NCT03366779_exc_T79
Qualifier
ankle level
NCT03366779_exc_T80
Scope
calf or ankle level
NCT03366779_exc_T81
Procedure
palpation
NCT03366779_exc_T82
Observation
diminished
NCT03366779_exc_T83
Observation
absent
NCT03366779_exc_T84
Scope
diminished or absent
NCT03366779_exc_T85
Condition
peripheral vascular disease
NCT03366779_exc_T86
Scope
diminished or absent by palpation
NCT03366779_exc_T87
Procedure
Screening on physical examination
NCT03366779_exc_T88
Scope
diminution or absence of dorsalis pedis or posterior tibialis pulses
NCT03366779_exc_T89
Negation
excluded
NCT03366779_exc_T90
Scope
absolute arterial pressure is below 50mm of Hg at the calf or ankle level
NCT03366779_exc_T91
Qualifier
significant
NCT03366779_exc_T92
Condition
peripheral neuropathy
NCT03366779_exc_T93
Qualifier
Type II
NCT03366779_exc_T94
Qualifier
Type I
NCT03366779_exc_T95
Condition
diabetes
NCT03366779_exc_T96
Scope
Type I or Type II
NCT03366779_exc_T97
Condition
systemic metabolic condition
NCT03366779_exc_T98
Qualifier
similar
NCT03366779_exc_T99
Condition
decreased sensation
NCT03366779_exc_T100
Qualifier
e or non-radi  in the low
NCT03366779_exc_T101
Qualifier
r and non-der  in the low
NCT03366779_exc_T102
Qualifier
non-dermatomal distribution
NCT03366779_exc_T103
Qualifier
lower extremities
NCT03366779_exc_T104
Scope
stocking-like or non-radicular and non-dermatomal distribution
NCT03366779_exc_T105
Qualifier
insulin-dependent
NCT03366779_exc_T106
Condition
diabetes mellitus
NCT03366779_exc_T107
Condition
morbidly obese
NCT03366779_exc_T108
Measurement
body mass index
NCT03366779_exc_T109
Value
>40
NCT03366779_exc_T110
Measurement
weighs
NCT03366779_exc_T111
Value
more than 100 lbs over ideal body weight
NCT03366779_exc_T112
Scope
body mass index >40, or weighs more than 100 lbs over ideal body weight
NCT03366779_exc_T113
Condition
hepatitis
NCT03366779_exc_T114
Condition
AIDS
NCT03366779_exc_T115
Condition
HIV
NCT03366779_exc_T116
Scope
hepatitis, AIDS, or HIV
NCT03366779_exc_T117
Qualifier
active
NCT03366779_exc_T118
Condition
rheumatoid arthritis
NCT03366779_exc_T119
Qualifier
other
NCT03366779_exc_T120
Condition
autoimmune disease
NCT03366779_exc_T121
Drug
titanium
NCT03366779_exc_T122
Drug
polyethylene
NCT03366779_exc_T123
Drug
polyester
NCT03366779_exc_T124
Condition
allergy
NCT03366779_exc_T125
Scope
titanium, polyethylene or polyester
NCT03366779_exc_T126
Condition
pregnant
NCT03366779_exc_T127
Mood
interested in becoming
NCT03366779_exc_T128
Condition
pregnant
NCT03366779_exc_T129
Temporal
in the next two (2) years
NCT03366779_exc_T130
Scope
pregnant or interested in becoming pregnant
NCT03366779_exc_T131
Condition
tuberculosis
NCT03366779_exc_T132
Condition
tuberculosis
NCT03366779_exc_T133
Temporal
in the past three (3) years
NCT03366779_exc_T134
Condition
malignancy
NCT03366779_exc_T135
Condition
non-melanoma skin cancer
NCT03366779_exc_T136
Qualifier
invasive
NCT03366779_exc_T137
Condition
treated with curative intent
NCT03366779_exc_T138
Negation
no
NCT03366779_exc_T139
Condition
signs or symptoms of the malignancy
NCT03366779_exc_T140
Temporal
for at least two (2) years
NCT03366779_exc_T141
Scope
treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years
NCT03366779_exc_T142
Negation
except
NCT03366779_exc_T143
Condition
active malignancy
NCT03366779_exc_T144
Observation
history
NCT03366779_exc_T145
Scope
invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years
NCT03366779_exc_T146
Scope
history of active malignancy
NCT03366779_exc_T147
Condition
immunologically suppressed
NCT03366779_exc_T148
Drug
steroids
NCT03366779_exc_T149
Multiplier
>1 month
NCT03366779_exc_T150
Temporal
over the past year
NCT03366779_exc_T151
Drug
anticoagulants
NCT03366779_exc_T152
Drug
aspirin
NCT03366779_exc_T153
Negation
other than
NCT03366779_exc_T155
Condition
alcohol dependency
NCT03366779_exc_T156
Condition
ency or nt psychos
NCT03366779_exc_T157
Condition
psychosocial disturbance
NCT03366779_exc_T158
Qualifier
significant
NCT03366779_exc_T159
Observation
life expectancy
NCT03366779_exc_T160
Value
less than three (3) years
NCT03366779_exc_T163
Observation
incarcerated