Department of Orthopaedic Surgery, Regensburg University Medical Center, Germany.
BMC Musculoskelet Disord. 2011 Aug 19;12:192. doi: 10.1186/1471-2474-12-192.
Impingement can be a serious complication after total hip arthroplasty (THA), and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM) as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated.
METHODS/DESIGN: A registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires) will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT) scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements.
In the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this study has been designed to compare minimally invasive computer-navigated "femur first" THA with a conventional technique for minimally invasive THA. The results of this trial will be presented as soon as they become available.
DRKS00000739.
撞击综合征是全髋关节置换术（THA）后的一种严重并发症，也是术后疼痛、脱位、无菌性松动和假体断裂的主要原因之一。微创 THA 和计算机导航手术几年前就已推出。我们根据“股骨优先”/“联合前倾角”的理念，开发了一种新的计算机辅助 THA 手术方法，该方法融合了优化杯位置的各个方面，全面解决了活动范围（ROM）以及杯包容和对准参数的问题。因此，本研究旨在评估这种计算机辅助手术方法是否可以改善人工关节的 ROM。其次，将评估临床和影像学结果。
方法/设计：将进行一项注册的患者和观察者盲法随机对照试验。纳入年龄在 50 至 75 岁之间因初次单侧 THA 而入院的患者。患者将随机分配接受微创计算机导航的“股骨优先”THA 或常规微创 THA 手术。术前和术后将评估自我报告的功能状态和健康相关生活质量（问卷）。将登记围手术期并发症。术后 6 周内进行放射学评估，包括计算机断层扫描（CT）扫描。使用图像处理软件对股骨/骨盆的 3D 重建，由独立的外部机构评估组件位置。术后 ROM 将通过自动确定骨性和假体撞击的算法计算得出。
过去，计算机导航提高了组件定位的准确性。到目前为止，只有很少的客观数据量化了计算机导航 THA 的风险和益处。因此，本研究旨在比较微创计算机导航的“股骨优先”THA 与常规微创 THA 技术。一旦获得结果，将尽快呈现该试验的结果。
DRKS00000739。
