title: Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial.
abstract: BACKGROUND
  Moderate to severe osteoarthrosis is the most common indication for Total Hip Arthroplasty (THA). Minimally Invasive Total Hip Surgery (MIS) and computer-navigated surgery were introduced several years ago. However, the literature lacks well-designed studies that provide evidence of superiority of computer-navigated MIS over a conventional THA technique. Hence, the purpose of this study is to compare (cost)effectiveness of computer-navigated MIS with a conventional technique for THA. It is our hypothesis that computer-navigated MIS will lead to a quicker recovery during the early postoperative period (3 months), and to an outcome at least as good 6 months postoperatively. We also hypothesize that computer-navigated MIS leads to fewer perioperative complications and better prosthesis positioning. Furthermore, cost advantages of computer-navigated MIS over conventional THA technique are expected.
  
  
  METHODS
  A cluster randomized controlled trial will be executed. Patients between the ages of 18 and 75 admitted for primary cementless unilateral THA will be included. Patients will be stratified using the Charnley classification. They will be randomly allocated to have computer-navigated MIS or conventional THA technique. Measurements take place preoperatively, perioperatively, and 6 weeks and 3 and 6 months postoperatively. Degree of limping (gait analysis), self-reported functional status and health-related quality of life (questionnaires) will be assessed preoperatively as well as postoperatively. Perioperative complications will be registered. Radiographic evaluation of prosthesis positioning will take place 6 weeks postoperatively. An evaluation of costs within and outside the healthcare sector will focus on differences in costs between computer-navigated MIS and conventional THA technique.
  
  
  CONCLUSIONS
  Based on studies performed so far, few objective data quantifying the risks and benefits of computer-navigated MIS are available. Therefore, this study has been designed to compare (cost) effectiveness of computer-navigated MIS with a conventional technique for THA. The results of this trial will be presented as soon as they become available.
authors.affiliation: Department of Orthopedics, University Medical Center Groningen, University of Groningen, PO Box 30001, 9700 RB Groningen, The Netherlands. i.reininga@orth.umcg.nl
authors.forename: Inge H F
authors.initials: IH
authors.lastname: Reininga
authors.forename: Robert
authors.initials: R
authors.lastname: Wagenmakers
authors.forename: Inge
authors.initials: I
authors.lastname: van den Akker-Scheek
authors.forename: A Dennis
authors.initials: AD
authors.lastname: Stant
authors.forename: Johan W
authors.initials: JW
authors.lastname: Groothoff
authors.forename: Sjoerd K
authors.initials: SK
authors.lastname: Bulstra
authors.forename: Wiebren
authors.initials: W
authors.lastname: Zijlstra
authors.forename: Martin
authors.initials: M
authors.lastname: Stevens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D002985:Clinical Protocols; D003289:Convalescence; D003362:Cost-Benefit Analysis; D005260:Female; D006621:Hip Joint / Q000601:surgery*; D006622:Hip Prosthesis / Q000191:economics / Q000592:standards; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D009426:Netherlands; D015207:Osteoarthritis, Hip / Q000601:surgery*; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011788:Quality of Life; D020127:Recovery of Function; D025321:Surgery, Computer-Assisted / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome