title: Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study.
abstract: METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Children's Orthopedics of Atlanta, Atlanta, GA, USA.
authors.forename: Dennis P
authors.initials: DP
authors.lastname: Devito
authors.forename: Leon
authors.initials: L
authors.lastname: Kaplan
authors.forename: Rupert
authors.initials: R
authors.lastname: Dietl
authors.forename: Michael
authors.initials: M
authors.lastname: Pfeiffer
authors.forename: Dale
authors.initials: D
authors.lastname: Horne
authors.forename: Boris
authors.initials: B
authors.lastname: Silberstein
authors.forename: Mitchell
authors.initials: M
authors.lastname: Hardenbrook
authors.forename: George
authors.initials: G
authors.lastname: Kiriyanthan
authors.forename: Yair
authors.initials: Y
authors.lastname: Barzilay
authors.forename: Alexander
authors.initials: A
authors.lastname: Bruskin
authors.forename: Dieter
authors.initials: D
authors.lastname: Sackerer
authors.forename: Vitali
authors.initials: V
authors.lastname: Alexandrovsky
authors.forename: Carsten
authors.initials: C
authors.lastname: Stüer
authors.forename: Ralf
authors.initials: R
authors.lastname: Burger
authors.forename: Johannes
authors.initials: J
authors.lastname: Maeurer
authors.forename: Gordon D
authors.initials: GD
authors.lastname: Donald
authors.forename: Donald G
authors.initials: DG
authors.lastname: Gordon
authors.forename: Robert
authors.initials: R
authors.lastname: Schoenmayr
authors.forename: Alon
authors.initials: A
authors.lastname: Friedlander
authors.forename: Nachshon
authors.initials: N
authors.lastname: Knoller
authors.forename: Kirsten
authors.initials: K
authors.lastname: Schmieder
authors.forename: Ioannis
authors.initials: I
authors.lastname: Pechlivanis
authors.forename: In-Se
authors.initials: IS
authors.lastname: Kim
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meyer
authors.forename: Moshe
authors.initials: M
authors.lastname: Shoham
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001863:Bone Screws; D002648:Child; D004867:Equipment Design; D005260:Female; D005471:Fluoroscopy; D005858:Germany; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000009:adverse effects / Q000295:instrumentation*; D015641:Radiography, Interventional; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012371:Robotics; D013131:Spine / Q000000981:diagnostic imaging / Q000601:surgery*; D025321:Surgery, Computer-Assisted / Q000009:adverse effects / Q000295:instrumentation*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult