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After several years of product development, animal trials and human cadaver testing, the SpineAssist--a miniature bone-mounted robotic system--has recently entered clinical use. To the best of the authors' knowledge, this is the only available image-based mechanical guidance system that enables pedicle screw insertion with an overall accuracy in the range of 1 mm in both open and minimally invasive procedures. In this paper, we describe the development and clinical trial process that has brought the SpineAssist to its current state, with an emphasis on the various difficulties encountered along the way and the corresponding solutions. All aspects of product development are discussed, including mechanical design, CT-to-fluoroscopy image registration, and surgical techniques. Finally, we describe a series of preclinical trials with human cadavers, as well as clinical use, which verify the system's accuracy and efficacy.

A series of 109 orthopedic operations was performed under intraosseous regional anesthesia on the upper and lower limbs. Anesthesia was satisfactory in 106 of the cases; in the other three, inadequate anesthesia was caused by faulty technique. The spread of lidocaine into the bone and venous network was demonstrated by radiography, and the blood levels after tourniquet release were below the toxic level. Intraosseous regional anesthesia proved to be a valuable technique to be used whenever intravenous anesthesia fails or is not feasible. Injection into cancellous bone (osteoclysis) is easily and quickly performed under aseptic conditions, and there were no systemic complications.

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