Helping patients and physicians choose the appropriate surgery for end stage hallux rigidus

项目摘要/摘要 该项目的主要目标是获得设计未来临床试验所需的观察数据。 拇指强直患者关节融合术与保留活动度手术的比较。HR是一个退化词 第一跖趾关节病(MTPJ1)。这是足部最常见的关节炎， 影响50岁以上人口的比例为1/40，男女比例为2：1。MTPJ1扮演着关键的角色 行走中的功能作用，因为它每走一步大约承担一个人体重的119%； 因此，关节疼痛和运动丧失会显著降低老年人的活动量和生活质量。 病人。HR通常通过对鞋或鞋内的修改与活动的修改相结合来治疗 和非甾体抗炎药。当这些治疗方法无效时，可能会进行手术。关节融合术是一种 有效的疼痛控制措施，但消除了关节处的运动，导致鞋类选择有限， 会对女性产生重大影响，特别是那些穿着不同鞋跟高度的鞋子的女性。这些 限制促使患者寻找避免MTPJ1运动的替代方案。早期有希望的结果已经 关于融合术和关节保留术的争论愈演愈烈，但它们的相对安全性和有效性并没有 已经成立了。多关节保留手术包括(1)各种关节成形术，(2)带或不带唇切除 截骨术，以及(3)人工软骨植入物。这些更现代的技术是无与伦比的 关节融合术，除了一项比较人工软骨植入物和关节融合术的非劣质试验 两年后，报告了类似的疼痛和功能以及种植失败的结果。没有可比性 评价阴唇切除术的试验。包括合成植入物在内的关节成形术增加了治疗成本，但保留了 动议。因此，有强烈的需求来确定运动备用是同等有效还是更有效 与关节融合术相比，结果对患者很重要。建议的观察性研究(及 后续的U01试验)旨在克服文献中的具体空白和设计 未来的试验包括：(1)使用来自几个采用多运动备用的中心的观测数据 手术和关节融合术，以确定是否存在明显的差异，需要单臂或 多个运动保留治疗组与融合组在未来试验中的比较：(2)确定HR的相关因素 使用带有观察性数据的探索性数据分析的专家小组开始 开发和验证新的人力资源分类系统的重要过程，(3)进行定性 对现有先导研究患者在随访过程中的不同时间点进行访谈，以确定 结果对他们来说是最重要的，这样我们才能确保我们在未来的试赛中包括的结果 这些偏好(如果男性和女性不同的话)，以及(4)设计和规划一个随机的 对照试验或未来的U01授权。

Project Summary/Abstract The primary objective of this project is to obtain observational data necessary to design a future clinical trial comparing arthrodesis to motion sparing surgery in patients with hallux rigidus (HR). HR is a degenerative disease of the first metatarsophalangeal joint (MTPJ1). It is the most common form of arthritis in the foot, affecting 1 in 40 people over the age of 50 with a 2:1 ratio of females to males. The MTPJ1 plays a critical functional role in walking as it carries approximately 119% of an individual's body weight with each step; therefore, the joint pain and loss of motion lead to a significant reduction in activity and quality of life for patients. HR is typically treated by modifications to or within the shoe combined with modifications of activity and NSAIDs. When these treatments are not effective, surgery may be performed. Arthrodesis (fusion) is an effective measure for pain control but eliminates motion at the joint leading to limited footwear options which can have a major impact on women, in particular, who wear shoes of varying levels of heel elevation. These limitations have driven patients to seek alternatives that spare MTPJ1 motion. Early promising results have intensified the debate over fusion versus joint sparing, but their comparative safety and efficacy is not established. Multiple joint sparing procedures include (1) various arthroplasties, (2) cheilectomy with or without osteotomy, and (3) a synthetic cartilage implant. These more modern techniques have not been compared with arthrodesis with the exception of one non-inferiority trial comparing a synthetic cartilage implant to arthrodesis which reported similar results for pain and function and implant failures after 2 years. There are no comparative trials evaluating cheilectomy. Arthroplasties including synthetic implants increase treatment costs but preserve motion. Therefore, there is a strong demand to determine if motion sparing is equally or more effective compared to arthrodesis in outcomes important to patients. The proposed observational study (and subsequent U01 trial) is intended to overcome the specific gaps in the literature and obstacles to designing a future trial including: (1) using observational data from several centers that employ multiple motion sparing procedures and arthrodesis to determine if there are appreciable differences that will require a single arm or multiple motion sparing treatment arms compared to fusion in a future trial, (2) identifying correlates of HR disease severity using an expert panel with exploratory data analysis of the observational data to begin the important process of developing and validating a novel HR classification system, (3) performing qualitative interviews of existing pilot study patients at various time points in the follow-up process to ascertain what outcomes are most important to them so that we can ensure the outcomes we include in the future trial match these preferences (for male and female should they differ), and (4) designing and planning a randomized controlled trial or a future U01 grant.