Study Design. Retrospective, multicenter study of robotically-guided spinal implant insertions. Clinical acceptance of the implants was assessed by intraoperative radiograph, and when available, postoperative computed tomography (CT) scans were used to determine placement accuracy.
Objective. To verify the clinical acceptance and accuracy of robotically-guided spinal implants and compare to those of unguided free-hand procedures.
Summary of Background Data. SpineAssist surgical robot has been used to guide implants and guide-wires to predefined locations in the spine. SpineAssist which, to the best of the authors' knowledge, is currently the sole robot providing surgical assistance in positioning tools in the spine, guided over 840 cases in 14 hospitals, between June 2005 and June 2009.
Methods. Clinical acceptance of 3271 pedicle screws and guide-wires inserted in 635 reported cases was assessed by intraoperative fluoroscopy, where placement accuracy of 646 pedicle screws inserted in 139 patients was measured using postoperative CT scans.
Results. Screw placements were found to be clinically acceptable in 98% of the cases when intraoperatively assessed by fluoroscopic images. Measurements derived from postoperative CT scans demonstrated that 98.3% of the screws fell within the safe zone, where 89.3% were completely within the pedicle and 9% breached the pedicle by up to 2 mm. The remaining 1.4% of the screws breached between 2 and 4 mm, while only 2 screws (0.3%) deviated by more than 4 mm from the pedicle wall. Neurologic deficits were observed in 4 cases yet, following revisions, no permanent nerve damage was encountered, in contrast to the 0.6% to 5% of neurologic damage reported in the literature.
Conclusion. SpineAssist offers enhanced performance in spinal surgery when compared to free-hand surgeries, by increasing placement accuracy and reducing neurologic risks. In addition, 49% of the cases reported herein used a percutaneous approach, highlighting the contribution of SpineAssist in procedures without anatomic landmarks.
This work describes a retrospective study of pedicle screws and guide-wires insertion under the guidance of the SpineAssist robotic platform. SpineAssist enhanced clinical acceptance, positioning accuracy, and reduced neurologic risks. Furthermore, its contribution was most appreciated with percutaneous approach, when anatomic landmarks are not visible.
From the *Children's Orthopedics of Atlanta, Atlanta, GA; †Hadassah University Hospital, Jerusalem, Israel; ‡Klinikum München Schwabing, Munich, Germany; §Helios Rosmann Hospital, Breisach, Germany; ¶Bethesda North, Cincinnati, OH; ∥Carmel Medical Center, Haifa, Israel; **Mazor Surgical Technology, Caesarea, Israel; ††Boston Spine Group, Newton, MA; ‡‡City Hospital Germany, Karlsruhe, Germany; §§Technical University of Munich, Munich, Germany; ¶¶Georg-August-University, Göttingen, Germany; ∥∥HSK-Klinikum Der Landeshauptstadt, Wiesbaden, Germany; ***Riverview Medical Center, Red Bank, NJ; †††Sheba Medical Center, Tel-Hashomer, Israel; ‡‡‡Medical Faculty, Mannheim University, Heidelberg, Germany; and §§§Technion-Israel Institute of Technology, Technion City, Haifa.
Acknowledgment date: April 20, 2009. First revision date: July 14, 2009. Second revision date: September 7, 2009. Third revision date: October 6, 2009. Fourth revision date: October 21, 2009. Acceptance date: October 22, 2009.
The device (s)/drug (s) is/are FDA-approved or approved by corresponding national agency for this indication. No funds were received in support of this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.
Boris Silberstein and Alon Friedlander received consultation fee. Moshe Shoham has stocks and decision making position.
Address correspondence and reprint requests to Moshe Shoham, DSc, Robotics Laboratory, Department of Mechanical Engineering, Technion-Israel Institute of Technology, Technion City, Haifa 32000, Israel; E-mail: email@example.com