中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (7): 1009-1014.doi: 10.3969/j.issn.2095-4344.2017.07.005

• 人工假体 artificial prosthesis • 上一篇    下一篇

SuperPATH微创入路人工股骨头置换治疗老年股骨颈骨折:前瞻性、开放性、随机对照临床试验

吴良浩,禹宝庆,陈帆成   

  1. 复旦大学附属浦东医院骨科,上海市  201399
  • 修回日期:2017-01-09 出版日期:2017-03-08 发布日期:2017-04-11
  • 通讯作者: 禹宝庆,博士,主任医师,教授,复旦大学附属浦东医院骨科,上海市 201399
  • 作者简介:吴良浩,男,1976年生,上海市人,汉族,2000年上海交通大学医学院毕业,副主任医师,主要从事骨关节疾病的治疗及骨科生物材料应用方面的研究。
  • 基金资助:

    上海市卫生局重点课题(20134039);浦东新区卫生系统重点学科群建设资助(PWZxq2014-03)

Supercapsular percutaneously-assisted total hip approach for the elderly with femoral neck fractures: study protocol for a prospective, open-label, randomized, controlled clinical trial  

Wu Liang-hao, Yu Bao-qing, Chen Fan-cheng   

  1. Department of Orthopedics, Pudong Hospital of Fudan University, Shanghai 201399, China
  • Revised:2017-01-09 Online:2017-03-08 Published:2017-04-11
  • Contact: Yu Bao-qing, M.D., Chief physician, Professor, Department of Orthopedics, Pudong Hospital of Fudan University, Shanghai 201399, China
  • About author:Wu Liang-hao, Associate chief physician, Department of Orthopedics, Pudong Hospital of Fudan University, Shanghai 201399, China
  • Supported by:

    the Major Project of Shanghai Municipal Health Department, China, No. 20134039; and a grant from the Major Discipline Construction in the Health System Pudong New District, Shanghai, China, No. PWZxq2014-03.

摘要:

文章快速阅读:



文题释义:
SuperPATH入路的优点:与传统入路相比,该入路中无神经血管界面,术中不易损伤血管神经,减少术中失血。保留了所有的关节囊和旋后肌群,显著降低了术后髋关节脱位的概率。
关节囊:包在关节的周围,两端附着于与关节面周缘相邻的骨面,可分为外表的纤维层和内面的滑膜层。
 
摘要
背景:传统的髋关节置换治疗老年股骨颈骨折一般采用后外侧入路,切口较大,术中需切断外旋肌群,术后易发生髋关节后脱位。SuperPATH微创入路是在原后外侧入路的基础上改良而来,该入路术中不易损伤血管神经,减少术中失血,保留了所有的关节囊和旋后肌群,显著减少术后髋关节脱位的发生率。
目的:假设与后外侧入路相比,SuperPATH微创入路人工股骨头置换治疗老年股骨颈骨折能取得更好的疗效,能有效促进患者术后髋关节功能恢复。
方法/设计:研究为前瞻性、单中心、开放性、随机对照临床试验,在中国上海市,复旦大学附属浦东医院完成。纳入老年股骨颈骨折患者40例,随机分为2组,试验组采用SuperPATH微创入路人工股骨头置换,对照组采用传统后入路人工股骨头置换,每组20例,随访1周,6个月。试验的主要观察指标为基线期,术后1周,6个月的髋关节Harris评分,观察髋关节功能恢复情况。试验的次要观察指标为术中手术切口长度、术中出血量、手术时间、术后24 h引流量、住院时间,以评价该入路方式的优势。其他观察指标为术后1周,6个月的不良反应发生率。试验经中国上海复旦大学附属浦东医院伦理委员会批准。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对治疗方案和过程均知情同意,并签署知情同意书。
讨论:试验旨在证实SuperPATH入路微创人工关节置换在治疗老年股骨颈骨折时较传统后外侧入路有优势,更有利于患者术后髋关节功能恢复,安全可靠。

中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱骨折;内固定;数字化骨科;组织工程

ORCID: 0000-0002-5258-8374(吴良浩)

关键词: 骨科植入物, 人工关节, 人工股骨头置换, 股骨颈骨折, SuperPATH微创入路, 后外侧入路, 老年, 髋关节Harris评分, 手术切口长度, 术中出血量, 手术时间, 引流量, 住院时间

Abstract:

BACKGROUND: Artificial hip replacement by the posterolateral approach is generally introduced as a treatment for femoral neck fracture in the elderly, but it is limited by the need for a large incision, cutting off the extortor, and postoperative hip dislocation. The supercapsular percutaneously-assisted total hip (SuperPATH) approach was developed based on the original lateral approach. The SuperPATH approach for hip replacement is characterized by the reduced chance of damaging blood vessels and nerves, reducing intraoperative blood loss, retaining all the joint capsules and supinator, and significantly reducing the incidence of postoperative hip dislocation.

OBJECTIVE: We hypothesized that the SuperPATH approach for hip replacement can achieve better efficacy in the elderly with femoral neck fractures and promote the recovery of postoperative hip function compared with the posterolateral approach.
METHODS/DESIGN: This is a prospective, single-center, open-label, randomized controlled clinical trial that will be completed at the Pudong Hospital of Fudan University, Shanghai, China. Forty patients with femoral neck fractures were randomly divided into two groups to undergo femoral head replacement by the SuperPATH approach in the experimental group, and by the conventional posterior approach in the control group. The follow-up period is 1 week and 6 months. The main outcome measures are Harris hip scores at baseline, and at 1 week and 6 months postoperatively to assess functional recovery of the hip. Secondary outcome measures to evaluate the advantages of the SuperPATH approach include the length of surgical incision, intraoperative blood loss, operative time, 24-hour postoperative drainage, and hospital stay. Other outcome measures include the incidence of adverse reactions at 1 week and 6 months after surgery. The study protocol was approved by the Ethics Committee of the Pudong Hospital of Fudan University, China, and performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent was obtained from all participants.
DISCUSSION: The aim of this trial is to test our hypothesis that the SuperPATH approach is safer and more reliable for hip functional recovery compared with the posterolateral approach for the artificial hip replacement in femoral neck fractures of the elderly. 

中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱骨折;内固定;数字化骨科;组织工程

Key words: Tissue Engineering, Femoral Neck Fractures, Hip Joint

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