Orthofix Cervical-Stim 2505CE, Инструкция по эксплуатации

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1 . P-values of comparison tests between treatment groups using Student’s t-test for numerical
variables and Pearson
x
2 test for categorical variables.
Data Analysis and Results
The primary effectiveness endpoint was the increase in frequency of cervical
fusion success by six months postoperatively as assessed by radiographic
evidence. Secondary endpoints were neurological function, VAS pain assessment
and Neck Disability Index. Safety was assessed by the frequency and severity
of adverse events.
Fusion was assessed by radiographs at each visit:
Radiographic fusion was defined as > 50% bony bridging on both the
superior and inferior graft interfaces between adjacent vertebral bodies
AND < 4° angulation (motion) between adjacent fused vertebrae on
flexion/extension lateral films AND absence of radiolucency.
Radiographic non-fusion was defined as < 50% bony bridging at either the
superior or inferior graft interface OR > 4° angulation (motion) between
adjacent fused vertebrae on flexion/extension lateral films OR presence
of radiolucency.
5
Variables
Age (years)
Mean
Range
SD
Gender
Female
Male
Race
Caucasian
African-American
Hispanic
Asian
Other
Smoking Status
Nonsmoking
Smoking
Number of
Subjects
(N = 323)
46.8
24 – 73
9.3
148 (45.8%)
175 (54.2%)
301 (93.2%)
17 ( 5.3%)
5 ( 1.6%)
0
0
159 (49.2%)
164 (50.8%)
Control
(n = 160)
46.7
26 – 72
9.2
75 (46.9%)
85 (53.1%)
150 (93.8%)
7 ( 4.4%)
3 ( 1.9%)
-
-
79 (49.4%)
81 (50.6%)
Cervical-Stim
(n = 163)
46.9
24-73
9.4
73 (44.8%)
90 (55.2%)
151 (92.6%)
10 ( 6.1%)
2 ( 1.2%)
-
-
80 (49.1%)
83 (50.9%)
P-value
1
0.846
0.706
0.703
0.958
Baseline Demographic Characteristics
Demographic Data
The subjects in this study had a mean age of 46.8 years (range 24 to 73 years).
Of the 323 subjects, 148 (45.8%) were female and 175 (54.2%) were male.
Three hundred one (93.2%) were Caucasian, while 17 (5.3%) were African
American and 5 (1.6%) were Hispanic. One hundred fifty-nine (49.2%) were
nonsmokers and 164 (50.8%) were smokers.