Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland
Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.
BMJ Open. 2021 Aug 27;11(8):e049298. doi: 10.1136/bmjopen-2021-049298.
Hallux rigidus is a common problem of pain and stiffness of the first metatarsophalangeal joint (MTPJ) caused mainly by degenerative osteoarthritis. Several operative techniques have been introduced for the treatment of this condition without high-quality evidence comparing surgical to non-surgical care. In this trial, the most common surgical procedure, arthrodesis, will be compared with watchful waiting in the management of hallux rigidus.
Ninety patients (40 years or older) with symptomatic first MTPJ osteoarthritis will be randomised to arthrodesis or watchful waiting in a ratio of 1:1. The primary outcome will be pain during walking, assessed using the 0-10 Numerical Rating Scale (NRS) at 1 year after randomisation. The secondary outcomes will be pain at rest (NRS), physical function (Manchester-Oxford Foot Questionnaire), patient satisfaction in terms of the patient-acceptable symptom state, health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and the rate of complications. Our null hypothesis is that there will be no difference equal to or greater than the minimal important difference of the primary outcome measure between arthrodesis and watchful waiting. Our primary analysis follows an intention-to-treat principle.
The study protocol has been approved by the Ethics Committee of Helsinki and Uusimaa Hospital District, Finland. Written informed consent will be obtained from all the participants. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
21 June 2021 V.2.0.
NCT04590313.
拇僵硬是第一跖趾关节（MTPJ）疼痛和僵硬的常见问题，主要由退行性骨关节炎引起。已经引入了几种手术技术来治疗这种疾病，但缺乏比较手术与非手术治疗的高质量证据。在这项试验中，最常见的手术方法，即融合术，将与观察等待治疗拇僵硬进行比较。
90 名（40 岁或以上）有症状的第一跖趾关节骨关节炎患者将按 1:1 的比例随机分配到融合术或观察等待组。主要结局将是随机分组后 1 年行走时的疼痛，使用 0-10 数字评定量表（NRS）评估。次要结局将是休息时的疼痛（NRS）、身体功能（曼彻斯特-牛津足部问卷）、患者对可接受症状状态的满意度、健康相关生活质量（EQ-5D-5L）、活动水平（足部和踝关节能力测量运动子量表）、镇痛药或矫形器的使用以及并发症发生率。我们的零假设是，融合术与观察等待之间在主要结局测量上没有差异等于或大于最小临床重要差异。我们的主要分析遵循意向治疗原则。
该研究方案已获得芬兰赫尔辛基和乌西玛区伦理委员会的批准。所有参与者都将获得书面知情同意。我们将通过同行评议的出版物和会议报告来传播这项研究的结果。
2021 年 6 月 21 日 V.2.0。
NCT04590313。
