Karma’s PEEK Posterior Fixation Strap Proved Safe and Reproducible in Recently Published Clinical Article
Karma®, an innovative, metal-free, cortico-pedicular posterior fixation device, is the first spine fixation device to utilize the dense cortico-pedicular corridor, providing an alternative to traditional posterior fixation methods.
The unique design of Karma’s curved drill creates an arcuate tunnel through the pedicle and cortical anchor points- IAP, SAP and Lamina, utilizing the densest cortical bone.
The Karma PEEK device is implanted through the tunnel and then tensioned for fixation.
Karma’s instrument set makes accessing the cortico-pedicular corridor safe and reproducible with the use of a proprietary curved drill. A safety study of the drill was conducted, and the results were recently published in the World Neurosurgery journal entitled Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion by Pierce D. Nunley, MD, et al.
The safety and reproducibility were tested in a cadaver study with four specimens, ranging in age from twenty to eighty-five years old. Nine spine surgeons with no prior experience using Karma performed the procedure on the specimens. The surgeons used Karma’s curved drill to create 35 tunnels at all lumbar levels in the specimens and then, the tunnels were evaluated using 3D fluoro. The outcome of the study reported no breaches of any kind and the drill averages about 7mm of bone stock between the anterior cortex and the spinal canal.
Keywords Karma, Posterior fixation, Lumbar spine, Pedicle screw, Cortical fixation