Kyphosis Clinical Trial
Official title:
Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
The Intellirod LOADPRO™ sensor is an intra-operative titanium and ceramic, single use,
disposable, strain sensing device, which includes hermetically sealed, micro
electromechanical systems (MEMS) and radio-frequency identification (RFID) technology to
enable measurement of intra-operative rod strain values. The transponder attaches to any
commercially available 5.5mm diameter CoCr or Ti Alloy rod commonly used for posterior
pedicle fixation systems. The transponder is used only to acquire rod strain values and a
unique device identification code, which is obtained by a hand-held reader, providing
real-time, objective measurement of the mechanical rod strain.
This non-significant risk case series is intended to assess the effectiveness of the
Intellirod LOADPRO™ sensor methodology and the intra-operative measurement of spinal rod
strain. The LOADPRO™ sensors will be removed from the spinal rods after obtaining load
measurements.
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