title: Development and validation of a quantitative method to assess pedicle screw loosening in posterior spine instrumentation on plain radiographs.
abstract: OBJECTIVE
  Currently, the diagnosis of pedicle screw (PS) loosening is based on a subjectively assessed halo sign, that is, a radiolucent line around the implant wider than 1 mm in plain radiographs. We aimed at development and validation of a quantitative method to diagnose PS loosening on radiographs.
  
  
  METHODS
  Between 11/2004 and 1/2010 36 consecutive patients treated with thoraco-lumbar spine fusion with PS instrumentation without PS loosening were compared with 37 other patients who developed a clinically manifesting PS loosening. Three different angles were measured and compared regarding their capability to discriminate the loosened PS over the postoperative course. The inter-observer invariance was tested and a receiver operating characteristics curve analysis was performed.
  
  
  RESULTS
  The angle measured between the PS axis and the cranial endplate was significantly different between the early and all later postoperative images. The Spearman correlation coefficient for the measurements of two observers at each postoperative time point ranged between 0.89 at 2 weeks to 0.94 at 2 months and 1 year postoperative. The angle change of 1.9° between immediate postoperative and 6-month postoperative was 75% sensitive and 89% specific for the identification of loosened screws (AUC = 0.82).
  
  
  CONCLUSIONS
  The angle between the PS axis and the cranial endplate showed good ability to change in PS loosening. A change of this angle of at least 2° had a relatively high sensitivity and specificity to diagnose screw loosening.
authors.affiliation: Institute for Evaluative Research in Orthopaedic Surgery, University of Bern, Stauffacherstrasse 78, 3014, Bern, Switzerland, emin.aghayev@memcenter.unibe.ch.
authors.forename: Emin
authors.initials: E
authors.lastname: Aghayev
authors.forename: Nicolas
authors.initials: N
authors.lastname: Zullig
authors.forename: Peter
authors.initials: P
authors.lastname: Diel
authors.forename: Daniel
authors.initials: D
authors.lastname: Dietrich
authors.forename: Lorin M
authors.initials: LM
authors.lastname: Benneker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001863:Bone Screws; D005260:Female; D005593:Fracture Fixation, Internal / Q000379:methods*; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000379:methods*; D011183:Postoperative Complications / Q000000981:diagnostic imaging; D011859:Radiography; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013123:Spinal Fusion / Q000379:methods*; D013904:Thoracic Vertebrae / Q000601:surgery; D013997:Time Factors