title: Patient-specific positioning guides for total knee arthroplasty: no significant difference between final component alignment and pre-operative digital plan except for tibial rotation.
abstract: OBJECTIVE
  To assess whether there is a significant difference between the alignment of the individual femoral and tibial components (in the frontal, sagittal and horizontal planes) as calculated pre-operatively (digital plan) and the actually achieved alignment in vivo obtained with the use of patient-specific positioning guides (PSPGs) for TKA. It was hypothesised that there would be no difference between post-op implant position and pre-op digital plan.
  
  
  METHODS
  Twenty-six patients were included in this non-inferiority trial. Software permitted matching of the pre-operative MRI scan (and therefore calculated prosthesis position) to a pre-operative CT scan and then to a post-operative full-leg CT scan to determine deviations from pre-op planning in all three anatomical planes.
  
  
  RESULTS
  For the femoral component, mean absolute deviations from planning were 1.8° (SD 1.3), 2.5° (SD 1.6) and 1.6° (SD 1.4) in the frontal, sagittal and transverse planes, respectively. For the tibial component, mean absolute deviations from planning were 1.7° (SD 1.2), 1.7° (SD 1.5) and 3.2° (SD 3.6) in the frontal, sagittal and transverse planes, respectively. Absolute mean deviation from planned mechanical axis was 1.9°. The a priori specified null hypothesis for equivalence testing: the difference from planning is >3 or <-3 was rejected for all comparisons except for the tibial transverse plane.
  
  
  CONCLUSIONS
  PSPG was able to adequately reproduce the pre-op plan in all planes, except for the tibial rotation in the transverse plane. Possible explanations for outliers are discussed and highlight the importance for adequate training surgeons before they start using PSPG in their day-by-day practise.
  
  
  METHODS
  Prospective cohort study, Level II.
authors.affiliation: Department of Orthopaedics, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands. boonenbert@gmail.com.
authors.forename: Bert
authors.initials: B
authors.lastname: Boonen
authors.affiliation: Department of Orthopaedics, Orbis Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
authors.forename: Martijn G M
authors.initials: MGM
authors.lastname: Schotanus
authors.affiliation: Department of Orthopaedics, AZ Sint-Maarten, Leopoldstraat 2, 2800, Mechelen, Belgium.
authors.forename: Bart
authors.initials: B
authors.lastname: Kerens
authors.affiliation: Department of Radiology, Orbis Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
authors.forename: Frans-Jan
authors.initials: FJ
authors.lastname: Hulsmans
authors.affiliation: Department of Surgery-Traumatology, Erasmus MC, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
authors.forename: Wim E
authors.initials: WE
authors.lastname: Tuinebreijer
authors.affiliation: Department of Orthopaedics, Orbis Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
authors.forename: Nanne P
authors.initials: NP
authors.lastname: Kort
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016118:Anterior Cruciate Ligament / Q000502:physiology*; D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D015331:Cohort Studies; D005260:Female; D005269:Femur / Q000601:surgery; D006801:Humans; D007720:Knee Prosthesis; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D056888:Patient Positioning; D011184:Postoperative Period; D012399:Rotation; D025321:Surgery, Computer-Assisted; D013977:Tibia / Q000502:physiology* / Q000601:surgery*; D014057:Tomography, X-Ray Computed
keywords: 3D CT scan; Accuracy; Alignment; Patient-specific positioning guides; Total knee arthroplasty