Leasure JM, Buckley J.
Jul 1, 2014
J Biomech Eng. 2014 Jul;136(7):0710101-8. doi: 10.1115/1.4026363.
A majority of the middle-aged population exhibit cervical spondylosis that may require decompression and fusion of the affected level. Minimally invasive cervical fusion is an attractive option for decreasing operative time, morbidity, and mortality rates. A novel interfacet joint spacer (DTRAX facet screw system, Providence Medical) promises minimally invasive deployment resulting in decompression of the neuroforamen and interfacet fusion. The present study investigates the effectiveness of the device in minimizing intervertebral motion to promote fusion, decompression of the nerve root during bending activity, and performance of the implant to adhere to anatomy during repeated bending loads. We observed flexion, extension, lateral bending, and axial rotation resonant overshoot mode (ROM) in cadaver models of c-spine treated with the interfacet joint spacer (FJ spacer) as stand-alone and supplementing anterior plating. The FJ spacer was deployed bilaterally at single levels. Specimens were placed at the limit of ROM in flexion, extension, axial bending, and lateral bending. 3D images of the foramen were taken and postprocessed to quantify changes in foraminal area. Stand-alone spacer specimens were subjected to 30,000 cycles at 2 Hz of nonsimultaneous flexion-extension and lateral bending under compressive load and X-ray imaged at regular cycle intervals for quantitative measurements of device loosening. The stand-alone FJ spacer increased specimen stiffness in all directions except extension. 86% of all deployments resulted in some level of foraminal distraction. The rate of effective distraction was maintained in flexed, extended, and axially rotated postures. Two specimens demonstrated no detectable implant loosening (<0.25 mm). Three showed unilateral subclinical loosening (0.4 mm maximum), and one had subclinical loosening bilaterally (0.5 mm maximum). Results of our study are comparable to previous investigations into the stiffness of other stand-alone minimally invasive technologies. The FJ spacer system effectively increased stiffness of the affected level comparable to predicate systems. Results of this study indicate the FJ spacer increases foraminal area in the cervical spine, and decompression is maintained during bending activities. Clinical studies will be necessary to determine whether the magnitude of decompression observed in this cadaveric study will effectively treat cervical radiculopathy; however, results of this study, taken in context of successful decompression treatments in the lumbar spine, are promising for the continued development of this product. Results of this biomechanical study are encouraging for the continued investigation of this device in animal and clinical trials, as they suggest the device is well fixated and mechanically competent.