Referencias - Bioventus Exogen Manual Del Usuario

Tabla 1 Resultado de estudio clínico sobre casos de fracturas no consolidadas
revisados por la FDA. Estratificación por variables de categorías
Variable categórica antes del inicio del Probabilidad exacta de Fisher de casos
tratamiento SAFHS completados†
Total Consoli- Falli- %Conso-
dados dos lidados
Sexo: Mujer 30 28 2 93%
Hombre 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 35 31 4 89%
kg 27 22 5 81%
>80 kg
Antigüedad 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%
N.º total de procedimientos
quirúrgicos combinando
la intervención inicial y las 0 20 15 5 75%
posteriores: 1 15 12 3 80%
2 24 23 1 96%
>3 15 14 1 93%
Días previos sin cirugía (días
transcurridos desde la última
intervención quirúrgica hasta el <82 9 9 0 100%
inicio del tratamiento SAFHS): 83-365 39 34 5 87%
366-730 12 12 0 100%
>731 14 9 5 64%
Hueso:
Tibia/Tibia-Peroné/Peroné 28 26 2 93%
Fémur 13 12 1 92%
Radio/Radio-Cúbito/Cúbito 7 6 1 86%
Húmero 6 5 1 83%
Metatarsianos 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 (metacarpianos) 1 1 0 100%
Otros (4-clavícula, 1-pelvis, 1-costilla) 6 6 0 100%
††Artrodesis tibio-astragalina
Huesos grandes frente a otros huesos
Huesos grandes 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
Labeling LBL-000319 [D] RELEASED
25
Desplazado al inicio de la terapia SAFHS
Falta (5) (2) (3)
No 56 50 6
Valor-p
Sí 13 12 1
Tipo de hueso grande. Solo en casos de
huesos grandes (5) (3) (2)
0,19
Falta 8 6 2
Metafisareo 46 45 1
Diafisario
0,52
Tipo de fractura inicial
Falta (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 SAFHS y durante el
mismo:
0,001
Varilla intramedular; solo para
hueso grande 43 38 5
No
Casos (N=59) 16 16 0
Sí
Reducción abierta 50 43 7
0,16
No
Fijación interna (RAFI) 24 21 3
Sí
Fijación externa; solo para 50 46 4
No
Casos de huesos grandes (N=59) 9 8 1
Sí
0,03
Conservador 58 51 7
No
(Escayola, férula, dispositivo
ortopédico)
Sí 16 13 3
Varilla intramedular o RAFI
o externa 10 7 3
No
Fijación o conservador 64 57 7
0,03 Sí
Terapia previa de litotricia fallida
No 72 62 10
Sí 2 2 0
¿Fumador?
Falta (2) (2) (0)
Nunca ha fumado 34 31 3
Dejó de fumar antes de SAFHS 10 8 2
Fumador durante SAFHS 28 23 5
Tipo de fractura no consolidada:
Falta (22) (17) (5)
Atrófica 41 36 5
0,02 Hipertrófica 11 11 0

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