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