Characteristics of eligible patients with knee osteoarthritis accepting versus declining participation in a randomised trial investigating the effect of weight loss versus knee arthroplasty to explore generalisability: A cross-sectional study.

IF 3.3 2区医学 Q1 ORTHOPEDICS Knee Surgery, Sports Traumatology, Arthroscopy Pub Date : 2025-01-05 DOI:10.1002/ksa.12546

Saber Muthanna Aljuboori, Robin Christensen, Marius Henriksen, Henning Bliddal, Anders Troelsen, Mikael Boesen, Asbjørn Seenithamby Poulsen, Camilla Toft Nielsen, Kristine Ifigenia Bunyoz, Søren Overgaard

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Abstract

Background: The INtensive diet versus Knee Arthroplasty (INKA) trial is a randomised trial assessing weight loss as an alternative to knee arthroplasty (KA) in obese patients with severe knee osteoarthritis (OA) awaiting KA (NCT05172843). The external validity of the INKA trial may be hampered if the patients who participate differ from those who decline participation.

Objective: To compare baseline characteristics between patients who enrol in the INKA trial and those who decline participation (i.e., non-INKA [nINKA] group).

Methods: We applied a cross-sectional study design, collecting and comparing baseline characteristics among all patients eligible for enrolment in the INKA trial from two clinics in Copenhagen. Imbalance between accepting (INKA) and declining (nINKA) groups was assessed using standardised differences (StdDs). We were prespecified that StdD values < 0.20 would indicate a clinically insignificant imbalance between groups, whereas values > 0.80 indicate incomparability.

Results: Of the 913 patients scheduled for KA, 888 were screened for INKA trial eligibility. Of the 217 eligible patients, 92 (42%) were enroled in the INKA trial, while 37 (17%) participated in the nINKA cross-sectional sample only. Patients enroled in INKA had on average a less severe Oxford knee score (OKS) of 22.0 (standard deviation = 6.7) compared to declining participants in nINKA with 18.6 (7.2), corresponding to an StdD of 0.50, and an absolute difference of 3.45 (95% confidence interval = 0.64-6.26, p = 0.017). A consistent similar pattern was noted across all secondary patient-reported outcomes applied in the INKA trial.

Conclusions: We observed discrepancies in patient-reported outcomes, with those who declined enrolment reporting more severe symptoms. These differences, however, were below the minimally important difference between groups for OKS, which is set to 4.84 points.

Level of evidence: Level II-III cross-sectional study in a randomised control trial.

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在一项调查减肥与膝关节置换术效果的随机试验中，符合条件的膝关节骨性关节炎患者接受与拒绝参与的特征：一项横断面研究。

背景：强化饮食与膝关节置换术（INKA）试验是一项随机试验，评估体重减轻作为等待KA的严重膝关节骨关节炎（OA）肥胖患者膝关节置换术（KA）的替代方案（NCT05172843）。如果参与的患者与拒绝参与的患者不同，INKA试验的外部有效性可能会受到阻碍。目的：比较参加INKA试验的患者和拒绝参加试验的患者（即非INKA [nINKA]组）的基线特征。方法：我们采用了横断面研究设计，收集并比较了来自哥本哈根两个诊所的所有符合INKA试验入组条件的患者的基线特征。采用标准化差异（stdd）评估接受（INKA）组和拒绝（nINKA）组之间的不平衡。我们预先指定StdD值0.80表示不可比性。结果：在913名计划进行KA的患者中，888名患者被筛选为INKA试验资格。在217例符合条件的患者中，92例（42%）参加了INKA试验，而37例（17%）仅参加了nINKA横断面样本。INKA患者的平均牛津膝关节评分（OKS）为22.0（标准差= 6.7），而nINKA患者的平均牛津膝关节评分为18.6(7.2)，对应的StdD为0.50，绝对差异为3.45（95%置信区间= 0.64-6.26,p = 0.017）。在INKA试验中应用的所有继发性患者报告的结果中都注意到一致的类似模式。结论：我们观察到患者报告的结果存在差异，拒绝入组的患者报告的症状更严重。然而，这些差异低于OKS组间最低重要差异（设定为4.84分）。证据水平：一项随机对照试验的II-III级横断面研究。

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

Knee Surgery, Sports Traumatology, Arthroscopy 医学-外科

CiteScore

8.10

自引率

18.40%

发文量

418

审稿时长

2 months

期刊介绍： Few other areas of orthopedic surgery and traumatology have undergone such a dramatic evolution in the last 10 years as knee surgery, arthroscopy and sports traumatology. Ranked among the top 33% of journals in both Orthopedics and Sports Sciences, the goal of this European journal is to publish papers about innovative knee surgery, sports trauma surgery and arthroscopy. Each issue features a series of peer-reviewed articles that deal with diagnosis and management and with basic research. Each issue also contains at least one review article about an important clinical problem. Case presentations or short notes about technical innovations are also accepted for publication. The articles cover all aspects of knee surgery and all types of sports trauma; in addition, epidemiology, diagnosis, treatment and prevention, and all types of arthroscopy (not only the knee but also the shoulder, elbow, wrist, hip, ankle, etc.) are addressed. Articles on new diagnostic techniques such as MRI and ultrasound and high-quality articles about the biomechanics of joints, muscles and tendons are included. Although this is largely a clinical journal, it is also open to basic research with clinical relevance. Because the journal is supported by a distinguished European Editorial Board, assisted by an international Advisory Board, you can be assured that the journal maintains the highest standards. Official Clinical Journal of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).