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一项随机对照试验的设计,旨在评估全髋关节置换术中外后侧入路与直接前侧入路的(成本)效益(POLADA试验)。

The design of a randomised controlled trial to evaluate the (cost-) effectiveness of the posterolateral versus the direct anterior approach for THA (POLADA - trial).

作者信息

Rykov K, Reininga I H F, Knobben B A S, Sietsma M S, Ten Have B L E F

机构信息

Department of Orthopaedic surgery, Martini Hospital Groningen, Groningen, The Netherlands.

Department of Trauma surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

BMC Musculoskelet Disord. 2016 Nov 15;17(1):476. doi: 10.1186/s12891-016-1322-2.

Abstract

BACKGROUND

Total hip arthroplasty (THA) is one of the most successful orthopaedic procedures. Because of the increasing number of THAs, a growing demand for faster recovery and a greater emphasis on cost-effectiveness, minimally invasive THAs have been introduced in the last decades. The direct anterior approach is a minimally invasive, tissue-sparing approach in which intermuscular planes are used. Theoretically, this approach should result in a faster recovery of physical functioning and higher health-related quality of life.

METHODS/DESIGN: A randomised controlled trial will be performed. Patients will be randomly allocated to undergo THA by means of the anterior or posterolateral approach. Both the intervention and control group will consist of two subgroups: 1) patients with a good bone stock who will receive an uncemented femoral stem, and 2) patients with a poor bone stock who will receive a cemented femoral stem. Patients between 18 and 90 years with primary or secondary osteoarthritis will be included. Physical functioning and health-related quality of life will be assessed by means of questionnaires. Additionally, performance based tests will be performed to objectively assess the physical functioning. Cost-effectiveness will be assessed by obtaining data on medical costs in and outside the hospital and other nonmedical costs. Measurements will take place preoperatively, two and six weeks, three months and one year postoperatively.

DISCUSSION

There is some evidence that the anterior approach results in reduced tissue damage and faster recovery in the direct postoperative period, compared to the posterolateral approach. However, there is still a lack of well-designed studies that have confirmed the better outcomes and cost-effectiveness of the anterior approach. Therefore, the purpose of this study is to assess the physical functioning, health related quality of life and the cost-effectiveness of the anterior approach, compared to the conventional posterolateral approach.

TRIAL REGISTRATION

Netherlands Trial Registry, number 5343 (registration date April 12, 2015).

摘要

背景

全髋关节置换术(THA)是最成功的骨科手术之一。由于THA手术数量不断增加,对更快康复的需求日益增长,且对成本效益的关注度更高,在过去几十年中引入了微创THA。直接前路手术是一种微创、保留组织的手术方法,利用肌间隙。理论上,这种方法应能使身体功能更快恢复,并提高与健康相关的生活质量。

方法/设计:将进行一项随机对照试验。患者将被随机分配接受前路或后外侧入路的THA手术。干预组和对照组均将分为两个亚组:1)骨量良好的患者,将接受非骨水泥型股骨柄;2)骨量差的患者,将接受骨水泥型股骨柄。纳入年龄在18至90岁之间的原发性或继发性骨关节炎患者。通过问卷调查评估身体功能和与健康相关的生活质量。此外,将进行基于表现的测试以客观评估身体功能。通过获取医院内外医疗费用及其他非医疗费用的数据来评估成本效益。测量将在术前、术后两周和六周、三个月及一年进行。

讨论

有一些证据表明,与后外侧入路相比,前路手术在术后直接阶段可减少组织损伤并加快恢复。然而,仍缺乏精心设计的研究来证实前路手术具有更好的效果和成本效益。因此,本研究的目的是评估与传统后外侧入路相比,前路手术的身体功能、与健康相关的生活质量和成本效益。

试验注册

荷兰试验注册中心,编号5343(注册日期:2015年4月12日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e85/5111237/830faab35448/12891_2016_1322_Fig1_HTML.jpg

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