Reininga Inge H F, Wagenmakers Robert, van den Akker-Scheek Inge, Stant A Dennis, Groothoff Johan W, Bulstra Sjoerd K, Zijlstra Wiebren, Stevens Martin
Department of Orthopedics, University Medical Center Groningen, University of Groningen, PO Box 30001, 9700 RB Groningen, The Netherlands.
BMC Musculoskelet Disord. 2007 Jan 11;8:4. doi: 10.1186/1471-2474-8-4.
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/DESIGN: 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.
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.
中重度骨关节炎是全髋关节置换术（THA）最常见的适应症。微创全髋关节手术（MIS）和计算机导航手术在数年前就已引入。然而，文献中缺乏精心设计的研究来证明计算机导航MIS优于传统THA技术。因此，本研究的目的是比较计算机导航MIS与传统THA技术的（成本）效益。我们的假设是，计算机导航MIS将导致术后早期（3个月）恢复更快，且术后6个月的结果至少同样良好。我们还假设计算机导航MIS导致围手术期并发症更少，假体定位更好。此外，预计计算机导航MIS比传统THA技术具有成本优势。
方法/设计：将进行一项整群随机对照试验。纳入年龄在18至75岁之间因初次非骨水泥型单侧THA入院的患者。患者将根据Charnley分类进行分层。他们将被随机分配接受计算机导航MIS或传统THA技术。在术前、围手术期以及术后6周、3个月和6个月进行测量。术前和术后将评估跛行程度（步态分析）、自我报告的功能状态以及与健康相关的生活质量（问卷调查）。记录围手术期并发症。术后6周对假体定位进行影像学评估。对医疗保健部门内外成本的评估将侧重于计算机导航MIS与传统THA技术之间的成本差异。
基于目前已开展的研究，几乎没有量化计算机导航MIS风险和益处的客观数据。因此，本研究旨在比较计算机导航MIS与传统THA技术的（成本）效益。本试验结果一旦可得将立即公布。
