title: No benefit of patient-specific instrumentation in TKA on functional and gait outcomes: a randomized clinical trial.
abstract: BACKGROUND
  Although some clinical reports suggest patient-specific instrumentation in TKA may improve alignment, reduce surgical time, and lower hospital costs, it is unknown whether it improves pain- and function-related outcomes and gait.
  
  
  OBJECTIVE
  We hypothesized that TKA performed with patient-specific instrumentation would improve patient-reported outcomes measured by validated scoring tools and level gait as ascertained with three-dimensional (3-D) analysis compared with conventional instrumentation 3 months after surgery.
  
  
  METHODS
  We randomized 40 patients into two groups using either patient-specific instrumentation or conventional instrumentation. Patients were evaluated preoperatively and 3 months after surgery. Assessment tools included subjective functional outcome and quality-of-life (QOL) scores using validated questionnaires (New Knee Society Score(©) [KSS], Knee Injury and Osteoarthritis Outcome Score [KOOS], and SF-12). In addition, gait analysis was evaluated with a 3-D system during level walking. The study was powered a priori at 90% to detect a difference in walking speed of 0.1 m/second, which was considered a clinically important difference, and in a post hoc analysis at 80% to detect a difference of 10 points in KSS.
  
  
  RESULTS
  There were improvements from preoperatively to 3 months postoperatively in functional scores, QOL, and knee kinematic and kinetic gait parameters during level walking. However, there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS, KOOS, SF-12, or 3-D gait parameters.
  
  
  CONCLUSIONS
  Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA. It is possible that differences may emerge, and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively. However, the goals of the study were to investigate the recovery period as early pain and functional outcomes are becoming increasingly important to patients and surgeons.
  
  
  METHODS
  Level I, therapeutic study. See the Instructions to Authors for a complete description of levels of evidence.
authors.affiliation: Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Abdel
authors.forename: Sébastien
authors.initials: S
authors.lastname: Parratte
authors.forename: Guillaume
authors.initials: G
authors.lastname: Blanc
authors.forename: Matthieu
authors.initials: M
authors.lastname: Ollivier
authors.forename: Vincent
authors.initials: V
authors.lastname: Pomero
authors.forename: Elke
authors.initials: E
authors.lastname: Viehweger
authors.forename: Jean-Noël A
authors.initials: JN
authors.lastname: Argenson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000295:instrumentation*; D001696:Biomechanical Phenomena; D005260:Female; D005684:Gait; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology / Q000601:surgery*; D007720:Knee Prosthesis; D008297:Male; D008875:Middle Aged; D010808:Physical Examination; D011474:Prosthesis Design; D020127:Recovery of Function; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking