First-in-man application of a cold ablation robot guided laser osteotome in midface osteotomies.

The aim of the study was to assess the clinical applicability of robot guided laser osteotomy for clinical application. This is the initial report on 14 consecutive patients requiring an orthognathic procedure with a midface osteotomy (no restrictions made on the surgical indication itself) who have undergone surgery by means of the Cold Ablation Laser Osteotome CARLO® (AOT Advanced Osteotomy Tools, Basle, Switzerland), which is an integrated system, functionally comprising: an Er:YAG laser source, intended to perform osteotomies using cold laser ablation, a robot arm that controls the position of the laser source, an optical tracking device that provides a continuous and accurate measurement of the position of the laser source and of reference elements attached to instruments or bones, a navigation system (software) that is able to read preoperatively defined planned osteotomies, and - under the control of a surgeon - performs the planned osteotomies. Safety was assessed by unimpaired postoperative healing and the absence of device related injuries; performance was assessed as ability to cut the maxilla along the preoperatively planned cutting path with a rage of accuracy of 2mm. Cold ablation robot-guided laser osteotomy could successfully be performed in 14 consecutive patients. No intraoperative complications or technical failure occurred. All osteotomies were within an average deviation of 0.80 mm (±0.26 mm) of the virtually preplanned location. The registration procedure to set up the robot at the beginning of the operation required a mean time of 4.6 min (±5.3min). In this report we describe the effective and successful routine use of Cold ablation robot-guided laser osteotomy in an actual clinical setting. It is a promising technical innovation that has the potential to set new standards for accuracy and safety in orthognathic surgery.