Development and calibration of a load sensing cervical distractor capable of withstanding autoclave sterilization

In surgery of the cervical spine, a Caspar pin distractor is often used to apply a tensile load to the spine in order to open up the disc space. This is often done in order to place a graft or other interbody fusion device in the spine. Ideally a tight interference fit is achieved. If the spine is over distracted, allowing for a large graft, there is an increased risk of subsidence into the endplate. If there is too little distraction, there is an increased risk of graft dislodgement or pseudoarthrosis. Generally, graft height is selected from preoperative measurements and observed distraction without knowing the intraoperative compressive load. This device was designed to give the surgeon an assessment of this applied load. Instrumentation of the device involved the application of strain gauges and the selection of materials that would survive standard autoclave sterilization. The device was calibrated, sterilized and once again calibrated to demonstrate its suitability for surgical use. Results demonstrate excellent linearity in the calibration, and no difference was detected in the pre- and post-sterilization calibrations.