2014, Number S1
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Rev Invest Clin 2014; 66 (S1)
Design and preliminary testing of an active intramedullary nail
Letechipia J, Alessi A, Rodríguez G, Asbun J
Language: English
References: 41
Page: 70-78
PDF size: 218.09 Kb.
ABSTRACT
Purpose. To enhance bone healing through controlled interfragmentary
movements, numerous experiments have been
conducted in animal models employing external fixation devices
to apply mechanical stimulation to the fracture site. However,
the efficacy of these fixators has been questioned. On the
other hand, intramedullary nailing is a widely established
clinical practice for reducing closed tibial fractures.
Material
and methods. In an effort to enhance bone healing, to overcome
the disadvantages of external fixators (i.e., non-uniform
linear movement), and to enhance the advantages of intramedullary
nailing (i.e., reduced risk of infection), an active intramedullary
nail has been designed and fabricated. Active nail
will provide controlled
in-situ stimulation (simultaneously
axial and shear) from a selectable acceleration (0.35 to 8.17g –
axial and 0.44g to 10.46 g - shear), associated to a discreet set
of high-frequency values (29.82 - 172.05 Hz - axial and 29.68
to 172.13 - shear).
Results. Five active intramedullary nails
were fabricated, capable of producing average acceleration
between 0.35 and 10.4 g. Acceleration is applied simultaneously
by all three axes (x, y, and z), resulting in axial and
shear stimulation. For each acceleration level, there are a limited
number of frequencies that can be selected. For each
frequency, there are a limited number of acceleration levels
that can be delivered. Bone morphology produces different levels
of acceleration in each axe. Acceleration levels are controlled
externally only by the variable power source (1.5V
DC to 6V
DC).
Accelerated
in-vitro testing showed that the life of the device
exceeded the required active period. Mechanical test showed
that in case of failure of the active component, the active
intramedullary nail will act as a standard nail, allowing
bone healing to continue its normal course.
Ex vivo experiments
were conducted inserting one active intramedullary nail
in two intact adult sheep tibia. Results indicate that the
strain induced by the active intramedullary nail (from 18.62
με to 38.13 με) has been reported to be osteogenic. Additional
experiments are required in order to statistically validate the
strain that can be induced in vivo by the active intramedullary
nail. Also,
in vivo experiments using simple fractures
of the tibial shaft need to be conducted in order to assess orif
effectively, applying active mechanical stimulation
in situ
enhances bone healing.
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