A customized modular reference array clamp for navigated spine surgery.

Introduction: The current authors have developed a modular system of reference array fixation which is tailored specifically to the spinal level being operated upon. They believe that this system may further increase the precision and accuracy of pedicle screw placement.

Materials And Methods: Two formalin-fixed whole body cadavers were used for this study. For cervical spine evaluation of the reference clamp, four odontoid screws (two per cadaver) for C1/C2-fusion and four lateral mass screws (two per cadaver) were implanted. Following navigated screw placement with 2D and 3D fluoroscopic verification, insertion of two lateral mass screws was performed. In the same way, lumbar and thoracic pedicle screws were implanted. Two pedicle screws were placed at two levels of the lumbar and two levels of the thoracic areas giving an overall of 16 screws implanted (8 cervical, 4 thoracic, and 4 lumbar). Postoperative evaluation involved comparison of postoperative 3D scans and preoperative planning images. A simple classification system was used for evaluation of any deviation from the planned trajectory.

Results: All pedicle screw placements were performed as planned without any technical problems. The reference array clamps remained in position at all the spinal levels at which they were employed with no loosening or displacement and no secondary damage to any of the spinous processes. Manual manipulation was performed but no displacement or slippage was observed. Image artefacts caused by the reference clamp were not significant as to obscure the area of interest. Both imaging modalities (Iso-C 3D and Vario 3D) generated sufficiently precise 3D images. There was no substantial difference in quality when those two systems were compared.

Discussion: Insufficient fixation of the reference clamp can lead to failure and complications. To date, no reference clamp systems have been developed specifically for navigated spine surgery.

Conclusions: Stable reference array fixation is a critical step in navigated surgery. To date, the same reference clamps have been applied to the spinal anatomy as have been developed originally for the appendicular skeleton. The current investigators have developed a novel modular clamp and have demonstrated its efficacy in a cadaveric model.