Bioventus EXOGEN Manual Del Usuario página 28

Table 1 Clinical Study results for the FDA reviewed non-union
cases – stratification by category variables
Categorical Variable Prior to Start
of SAFHS Treatment
Gender:
Age:
Weight (kg):
65-80 kg
Fracture Age: 256-365 Days
366-730 Days
731-1826 Days
>1827 Days
Total no. surgical procedures
combining initial and
subsequent interventions:
Prior days without surgery
(days from last surgical
procedure to SAFHS start):
Bone:
Tibia/Tibia-Fibula/Fibula
Radius/Radius-Ulna/Ulna
Humerus
Metatarsal
Other Foot Bones (calcaneus)
Scaphoid
Other Hand Bones (metacarpal)
Other (4-clavicle, 1-pelvis, 1-rib)
††Tibio-talar arthrodesis
Long Bones vs Other Bones
Long Bones
13 femur
6 humerus
4 metatarsal
1 metacarpal
Other Bones
1 calcaneus
4 clavicle
6 scaphoid
Labeling LBL-000319 [D] RELEASED
25
Completed Cases Fisher's Exact Probability†
Total Healed Failed
Female 30 28 2
Male 44 36 8
<17 1 1 0
18-29 12 9 3
30-49 32 27 5
50-64 21 19 2
>65 8 8 0
<65 kg 12 11 1
35 31 4
> 80 kg 27 22 5
20 19 1
27 24 3
17 16 1
10 5 5
0 20 15 5
1 15 12 3
2 24 23 1
>3 15 14 1
<82 9 9 0
83-365 39 34 5
366-730 12 12 0
>731 14 9 5
28 26 2
Femur 13 12 1
7 6 1
6 5 1
4 4 0
1 1 0
Ankle†† 2 1 1
6 2 4
1 1 0
6 6 0
59 54 5
28 tibia
7 radius
15 10 5
1 pelvis
1 rib
2 ankle
Displaced at the start of SAFHS Therapy
%Healed p-value
93%
0.19
82%
Long bone type - Only for long bone
cases
100%
75%
84% 0.52
91%
100%
Initial Fracture Type
92%
89% 0.65
81%
95%
89%
0.001
Fixation present at start of
94%
and during SAFHS treatment:
50%
IM rod; only for long bone
No
Cases
Yes
75%
0.16
80% Open reduction
96% No
93% Internal fixation (ORIF)
Yes
External fixation; only for
No
100%
Long bone cases
0.03
87%
Yes
100%
Conservative
64%
No
(Cast, splint, brace)
Yes
93%
IM rod, or ORIF, or External
92%
No
86%
Fixation, or conservative
83%
Yes
100%
0.03
100%
Prior failed Lithotripsy Therapy
50%
33%
100%
100% Smoking Status:
Stopped smoking prior to SAFHS start
92%
Non-union type:
0.02
67%
Missing (5) (2)
No 56 50
Yes 13 12
(5) (3)
Missing 8 6
Metaphyseal 46 45
Diaphyseal
Missing (4) (2)
Closed 40 34
Open 22 21
Arthrodesis 2 1
Osteotomy 6 6
43 38
(N=59)
16 16
50 43
24 21
50 46
(N=59)
9 8
58 51
16 13
10 7
64` 57
No 72 62
Yes 2 2
Missing (2) (2)
Never smoked 34 31
10 8
Smoker at SAFHS 28 23
Missing (22) (17)
Atrophic 41 36
Hypertrophic 11 11
(3)
1.00
6 89%
1 92%
(2)
2 75% 0.05
1 98%
(2)
6 85%
0.16
1 95%
1 50%
0 100%
5 88%
0 100% 0.31
7 86%
3 88% 1.00
4 92%
1 89% 0.58
7 88%
3 81% 0.44
3 70%
7 89% 0.16
10 86% 1.00
0 100%
(0)
3 91% 0.47
2 80%
5 82%
(5)
0.57
5 88%
0 100%