Validation

Checklist

Fix spine specimens of varying lengths and potted ends

The device can fix spine models with different potted end shapes/sizes and spine lengths. Demonstrations of the device holding various lengths (first image, left) were done with models 5.5", 5", and 8.5" long, listed in order from left to right. The potted end shapes were either rectangular or circular (second image, left). From left to right, the sizes of the bases were 3.5" x 3.5", 3" diameter, and 5" x 5".

Compatible with fluoroscopy

We checked the compatibility between our device and fluoroscopy by using the spine holder in tandem with the fluoroscope in the Orthofix cadaver lab (first image, left). We simulated the positioning of an interbody cage along a model spine (second image, left), which proves the user is able to operate the holder in tandem with the fluoroscope. Then we imaged using the fluoroscope and the resulting image (third image, left) reveals that visibility isn’t obstructed by our brackets, which have been designed to be equal to or less than the height of most potted ends.

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Rotate specimens 360º and lock in place

The device is able to rotate in a complete circle in a clockwise and counterclockwise direction. The dowel pins, when inserted into one of the 24 available holes, lock the rotation mechanism in place. There are 12 angles available for surgeons to choose from and the dowel pins must be inserted on both sides to firmly fix the rotation.

A demonstration of the holder can be seen in the video on the left.

Sterilizable

Sufficient sterilization is done with an alcohol wipe down and we tested this by simulating a cleaning process with our device. We were able to reach all crevices that could potentially touch biological material, such as tissue and blood. For more thorough sterilization, we planned for our holder to be compatible with autoclaving. The materials used for our device are aluminum 6061 and stainless steel 318. These materials can withstand autoclave heat, which can get up to 275º Fahrenheit, and are corrosion resistant, making them suited for repeated use.

Portable

Each half of the holder is 17.45 lbs, making the total weight about 35 lbs. Our team set the validation criteria for portability as being under 50 lbs, which our device clears.

For context, each holder half weighs similarly to a heavy grocery bag or a 2 gallon water jug.

Page Leader: Brina Nguyen

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