3
Device
Description
Chapter 2
Design Description
The SIDEKICK® EZ FRAME™ was designed to address the need for a simplified
approach to external fixation. The system allows for the management of diabetic
Charcot reconstruction, triple arthrodesis, fusion of the midfoot and rearfoot,
challenging comminuted trauma, and most foot pathology not requiring fixation
above the ankle. It is a viable tool for offloading and/or immobilizing wounds
associated with diabetic Charcot disease.
The system features transosseous thin wire fixation, taking advantage of the
proven benefits of minimally invasive external fixator concepts. Bone segments
are easily and effectively manipulated for the purposes of midfoot and rearfoot
joint arthrodesis and for fusion of midfoot and rearfoot osteotomies. As with
other external fixators, the frame may be applied with or without adjunct internal
fixation.
By utilizing a unique combination of total contact casting concepts for the tibia
and thin wire fixation in the foot, tibial wires or pins are not needed. By requiring
no pins or wires in the tibia, the SIDEKICK® EZ FRAME™ eliminates complications
associated with tibial fixation elements and the time it takes to place these pins
and wires. The tibial boot portion of the frame helps facilitate positioning and
centering of the leg and foot, and the rocker plate helps to align the foot in a
neutral position. This simplifies frame application compared to traditional circular
frames.
A rocker-bottom sole and rocker plate is attached to the foot ring. This rocker
plate features a cushioned surface insole upon which the foot can rest during
the healing process after the surgery. This insole (foot pad) may be modified
to accommodate compromised soft tissue as needed, by cutting it to relieve
pressure on compromised soft tissue. The position of the rocker plate can be
adjusted using optional spacers so that the foot is suspended, with no contact or
weight on the plantar surface of the foot. This can be particularly useful following
a flap or skin grafting procedure associated with diabetic Charcot reconstruction.
Spacers are available in two (2) thicknesses (5mm and 10mm).
The sterile boot liner allows for a custom tibial fit and is designed to enhance
patient comfort.
The SIDEKICK® EZ FRAME™ is available in Standard and Large size kits.
The SIDEKICK® FREEDOM™ Circular Instrument Kit (RNRCKIT1) should be used
with the SIDEKICK® EZ FRAME™ System.
Replacement Boot Liners (Standard and Large), rocker-bottom soles, and foot
pads are available. The SIDEKICK® EZ FRAME™, and all frame components
(excluding instruments) are intended for single-use only.
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