Bioventus EXOGEN Guia Del Usuario página 51

Tabla 1 Resultados de estudios clínicos para los casos de no unión
revisados por la FDA: estratificación por variables de categorías
Variable de categoría antes de iniciar Probabilidad exacta de Fisher de casos
el tratamiento de SAFHS completados†
Total Conso- Fallido % de
lidado consoli-
dación
Sexo: Femenino 30 28 2 93%
Masculino 44 36 8 82%
Edad: <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%
Peso (kg): <65 kg 12 11 1 92%
65-80 kg 35 31 4 89%
>80 kg 27 22 5 81%
Edad de la fractura: 256-365 días 20 19 1 95%
366-730 días 27 24 3 89%
731-1826 días 17 16 1 94%
>1827 días 10 5 5 50%
Cantidad total de
procedimientos quirúrgicos
que combinan las
intervenciones iniciales
y posteriores:
0
20
15
5
75%
1 15 12 3 80%
2 24 23 1 96%
>3 15 14 1 93%
Días anteriores sin cirugía
(días desde el último
procedimiento quirúrgico
hasta el inicio de SAFHS): <82 9 9 0 100%
83-365 39 34 5 87%
366-730 12 12 0 100%
>731 14 9 5 64%
Hueso:
Tibia/tibia-fíbula/fíbula 28 26 2 93%
Fémur 13 12 1 92%
Radio/radio-ulna/ulna 7 6 1 86%
Húmero 6 5 1 83%
Metatarso 4 4 0 100%
Otros huesos del pie (calcáneo) 1 1 0 100%
Tobillo†† 2 1 1 50%
Escafoides 6 2 4 33%
Otros huesos de la mano (metacarpiano) 1 1 0 100%
Otro (4 clavículas, 1 pelvis, 1 costilla) 6 6 0 100%
††Artrodesis tibiotalar
Huesos largos frente a otros huesos
Huesos largos 59 54 5 92%
28 tibias
13 fémures
7 radios
6 húmeros
4 metatarsianos
1 metacarpiano
Otros huesos
1 calcáneo 15 10 5 67%
4 clavículas
1 pelvis
1 costilla
6 escafoides
2 tobillos
25
Desplazado al comienzo de la terapia
de SAFHS
Faltante (5) (2) (3)
Valor p
No 56 50 6
Sí 13 12 1
Tipo de hueso largo: solo para casos
de huesos largos
0,19
Faltante (5) (3) (2)
Metafisial 8 6 2
Diafisial 46 45 1
0,52
Tipo de fractura inicial
Faltante (4) (2) (2)
Cerrada 40 34 6
Abierta 22 21 1
Artrodesis 2 1 1
0,65
Osteotomía 6 6 0
Fijación presente al inicio
del tratamiento de SAFHS
0,001
y durante este:
Clavo intramedular; solo
para huesos largos
No 43 38 5
Casos (N=59)
Sí 16 16 0
Reducción abierta
0,16
No
50
43
7
Fijación interna (ORIF)
Sí 24 21 3
Fijación externa; solo para
No 50 46 4
Casos de huesos largos (N=59)
Sí 9 8 1
Conservador
0,03
No 58 51 7
(Yeso, tablilla, soporte)
Sí 16 13 3
Clavo intramedular, ORIF
o externo
No 10 7 3
Fijación o conservador
Sí 64 57 7
Terapia previa de litotripsia fallida
No 72 62 10
0,03
Sí 2 2 0
Estado de tabaquismo:
Faltante (2) (2) (0)
Nunca fumó 34 31 3
Dejó de fumar antes de iniciar el
tratamiento de SAFHS 10 8 2
Fuma durante el tratamiento de SAFHS 28 23 5
Tipo de fractura no consolidada:
Faltante (22) (17) (5)
Atrópico 41 36 5
Hipertrópico 11 11 0
0,02
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