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一项关于通过仰卧位前外侧入路进行全髋关节置换术的患者特异性股骨导向器的开放标签、单臂研究,与三维手术支持软件相关联:研究方案。

An Open-Label, Single-Arm Study of a Patient-Specific Femoral Guide for Total Hip Arthroplasty via the Anterolateral Supine Approach, Linked with Three-Dimensional Surgical Support Software: Study Protocol.

作者信息

Kida Daihei, Hashimoto Hiroya, Ito Noriko, Kito Yukari, Mori Kouichi, Takahashi Nobunori, Tomita Yasushi

机构信息

Department of Orthopedic Surgery and Rheumatology, National Hospital Organization Nagoya Medical Center.

Clinical Research Center, National Hospital Organization Nagoya Medical Center.

出版信息

Kurume Med J. 2019 May 16;65(2):71-75. doi: 10.2739/kurumemedj.MS652002. Epub 2018 Sep 10.

DOI:10.2739/kurumemedj.MS652002
PMID:30197407
Abstract

In total hip arthroplasty (THA), it is generally accepted that the bones of the acetabular cup and femur of hip joint must be accurately cut and components (artificial joint parts) be implanted in exact positions at exact angles to achieve improvement of daily living (ADL) and quality of life (QOL). However, with the conventional surgical method, it is difficult to grasp and measure the acetabular cup and femoral stem precisely during surgery, making some kind of reliable guide necessary. Although it was reported that an accurate angle was achieved in acetabular cup implantation by support instruments for surgical planning, an effective support instrument is now being developed for stem implantation on the out-of-reach femur side. This is the first clinical study to assess the efficacy and safety of anterolateral approach THA using an extracorporeal patient-specific femoral guide (PSG) for stem implantation with three-dimensional (3D) surgical support software in patients with hip joint disease.

摘要

在全髋关节置换术(THA)中,人们普遍认为,髋关节髋臼杯和股骨的骨头必须精确切割,并且部件(人工关节部件)必须以精确的角度植入精确的位置,以实现日常生活能力(ADL)和生活质量(QOL)的改善。然而,采用传统手术方法时,手术过程中难以精确把握和测量髋臼杯和股骨干,因此需要某种可靠的导向装置。尽管有报道称,通过手术规划的支撑器械在髋臼杯植入时能达到精确角度,但目前正在开发一种有效的支撑器械,用于在难以触及的股骨侧进行柄植入。这是第一项评估使用体外患者特异性股骨导向器(PSG)结合三维(3D)手术支持软件进行柄植入的前外侧入路THA对髋关节疾病患者的疗效和安全性的临床研究。

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