Temporal Analysis of Patients Eligible for Randomized Controlled Trials in Total Hip Arthroplasty

IF 2.1 Q3 ORTHOPEDICS

Arthroplasty Today Pub Date : 2026-06-01 Epub Date: 2026-05-25 DOI:10.1016/j.artd.2026.101995

Brynn P. Charron MD, MSc , Ethan Pieterman , Brent Charron , Elia Arbana MD , Brent A. Lanting MD, MSc

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引用次数: 0

Abstract

Background

There has been a shift in the demographics of patients undergoing elective lower extremity joint arthroplasties in recent years. This study aimed to assess whether research has kept pace with changing demographics through analyzing inclusion and exclusion criteria of randomized controlled trials (RCTs) relevant to total hip arthroplasties (THAs).

Methods

Cross-sectional analysis of RCTs studying primary THAs indexed on ClinicalTrials.gov was performed. Trial characteristics regarding inclusion and exclusion criteria of 706 studies initiated between 1994-2023 were analyzed. Sample size, type of intervention, year of study initiation, length of study, and inclusion/exclusion criteria were evaluated.

Results

An increasing number of THA-based RCTs were initiated over the study period (1994-2004: 5.18 studies/y, 2021-2023: 36.7 studies/y). The majority of included RCTs had an upper age exclusion criterion (1994-2004: 65.9%, 2021-2023: 53.6%). Body mass index (BMI) restrictions have become more common than previously (1994-2004: 5.3%, 2021-2023: 29.1%); however, the range has expanded to include higher BMI limits. The most common exclusion criteria based upon health comorbidities included psychiatric health and cognitive impairment (36.4%), neurologic and neuromuscular dysfunction (32.6%), and systemic infections (31.4%).

Conclusions

Regarding elective primary THA, it is recognized that the age and BMI of patients have shifted substantially over recent decades. This study revealed that restrictions on participant age continue to be prevalent. Although the average BMI of patients undergoing elective THA is rising, BMI is increasingly being implemented as an exclusion criterion. Critical assessment of inclusion and exclusion criteria for all studies, especially RCTs, given their associated cost and potential impact, requires further attention in orthopaedics.

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全髋关节置换术中符合随机对照试验的患者时间分析。

背景：近年来，选择性下肢关节置换术患者的人口统计数据发生了变化。本研究旨在通过分析与全髋关节置换术（THAs）相关的随机对照试验（rct）的纳入和排除标准，评估研究是否跟上了人口统计学变化的步伐。方法：对ClinicalTrials.gov检索的原发性tha的随机对照试验进行横断面分析。分析1994-2023年间706项研究的纳入和排除标准的试验特征。评估样本量、干预类型、研究开始年份、研究时长和纳入/排除标准。结果：在研究期间，越来越多的基于tha的随机对照试验被启动（1994-2004年：5.18项研究/年，2021-2023年：36.7项研究/年）。大多数纳入的rct具有较高的年龄排除标准（1994-2004:65.9%,2021-2023:53.6%）。身体质量指数（BMI）限制比以前更普遍（1994-2004年：5.3%，2021-2023年：29.1%）；然而，这个范围已经扩大到包括更高的BMI限制。基于健康合并症的最常见的排除标准包括精神健康和认知障碍（36.4%）、神经和神经肌肉功能障碍（32.6%）和全身感染（31.4%）。结论：关于选择性原发性THA，人们认识到，近几十年来患者的年龄和BMI发生了重大变化。这项研究表明，对参与者年龄的限制仍然很普遍。尽管选择性THA患者的平均BMI正在上升，但BMI正越来越多地被用作排除标准。考虑到相关成本和潜在影响，对所有研究，特别是随机对照试验的纳入和排除标准进行关键评估，需要在骨科领域得到进一步关注。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Arthroplasty Today Medicine-Surgery

CiteScore

2.90

自引率

0.00%

发文量

258

审稿时长

40 weeks

期刊介绍： Arthroplasty Today is a companion journal to the Journal of Arthroplasty. The journal Arthroplasty Today brings together the clinical and scientific foundations for joint replacement of the hip and knee in an open-access, online format. Arthroplasty Today solicits manuscripts of the highest quality from all areas of scientific endeavor that relate to joint replacement or the treatment of its complications, including those dealing with patient outcomes, economic and policy issues, prosthetic design, biomechanics, biomaterials, and biologic response to arthroplasty. The journal focuses on case reports. It is the purpose of Arthroplasty Today to present material to practicing orthopaedic surgeons that will keep them abreast of developments in the field, prove useful in the care of patients, and aid in understanding the scientific foundation of this subspecialty area of joint replacement. The international members of the Editorial Board provide a worldwide perspective for the journal''s area of interest. Their participation ensures that each issue of Arthroplasty Today provides the reader with timely, peer-reviewed articles of the highest quality.