22
Appendix 1
Clinical Study Results for the Nonunion Supplement
Completed Cases—Stratification by Categorical
Variables
†
Two-sided exact p-value, Fisher’s exact test, testing homogeneity of strata.
Categorical Variable Prior to
Start of SAFHS Treatment
6
7
8
9
39
12
14
28
13
7
6
4
1
2
6
1
6
59
Total Healed Failed % Healed p-value
ROW
9
34
12
9
26
12
6
5
4
1
1
2
1
6
54
0
5
0
5
2
1
1
1
0
0
1
4
0
0
5
100%
87%
100%
64%
93%
92%
86%
83%
100%
100%
50%
33%
100%
100%
92%
0.03
0.03
0.02
Prior days without surgery (days
from last surgical procedure
to SAFHS start):
<_82
83-365
366-730
>_ 731
Bone:
Tibia/Tibia-Fibula/Fibula
Femur
Radius/Radius-Ulna/Ulna
Humerus
Metatarsal
Other Foot Bones (calcaneus)
Ankle
††
Scaphoid
Other Hand Bones (metacarpal)
Other (4-clavicle, 1-pelvis, 1-rib)
Tibio-talar arthrodesis
††
Long Bone vs. Other Bones:
Long Bones
28 tibia
13 femur
7 radius
6 humerus
4 metatarsal
1 metacarpal
Completed Cases Fisher’s Exact Probability
†
Categorical Variable Prior
to Start of SAFHS™
Treatment
1
2
3
4
5
Gender:
Female
Male
Age:
<_17
18–29
30–49
50–64
>_ 65
Weight (kg):
<65 kg.
65–80 kg.
>80 kg.
Fracture age:
256–365 days
366–730 days
731–1826 days
>_ 1827 days
Total no. surgical procedures
combining initial and all
subsequent
0
interventions:
1
2
>_ 3
Completed Cases Fisher’s
Exact Probability
†
30
44
1
12
32
21
8
12
35
27
20
27
17
10
20
15
24
15
Total Healed Failed % Healed p-value
ROW
28
36
1
9
27
19
8
11
31
22
19
24
16
5
15
12
23
14
2
8
0
3
5
2
0
1
4
5
1
3
1
5
5
3
1
1
93%
82%
100%
75%
84%
91%
100%
92%
89%
81%
95%
89%
94%
50%
75%
80%
96%
93%
0.19
0.52
0.65
0.001
0.16
