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

帮助患者和医生选择适合末期拇强直的手术

• 批准号: 10655575
• 负责人: Daniel C Norvell
• 金额: $ 11.99万
• 依托单位: SEATTLE INST FOR BIOMEDICAL/CLINICAL RES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-16 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10655575
• 关键词: Affect; Age; Anatomy; Arthralgia; Arthritis; Arthrodesis; Automobile Driving; Body Weight; Case Series; Characteristics; Classification; Clinical; Clinical Trials; Consultations; Data; Data Analyses; Decision Making; Degenerative Disorder; Development; Devices; Enrollment; Ensure; Excision; Failure; Female; Future; Grant; Hallux Rigidus; Heel; Implant; Individual; Industry; Institution; Institutional Review Boards; Interview; Joint Prosthesis; Joints; Lead; Learning; Literature; Manuals; Marketing; Measures; Metatarsophalangeal joint structure; Modernization; Modification; Motion; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Non-Steroidal Anti-Inflammatory Agents; Observational Study; Operative Surgical Procedures; Osteotomy; Outcome; Outcome Measure; Pain; Pain management; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Persons; Physicians; Pilot Projects; Play; Procedures; Process; Prospective, cohort study; Protocols documentation; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Replacement Arthroplasty; Reporting; Research; Research Personnel; Resources; Role; Severity of illness; Shapes; Shoes; Site; System; Techniques; Time; Toes; Training; Treatment Cost; Treatment Effectiveness; Uncertainty; Universities; Walking; Washington; Woman; arm; bone; cartilage implant; cohort; comparative effectiveness; comparative efficacy; comparative safety; comparative trial; design; disease classification; electronic data capture system; follow-up; foot; improved; innovation; interest; male; novel; operation; pain reduction; power analysis; preference; preservation; radiological imaging; recruit; success; treatment arm; trial comparing

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.

项目总结/摘要 该项目的主要目的是获得设计未来临床试验所需的观察数据 在拇趾僵硬（HR）患者中比较关节融合术与运动保留手术。HR是一个退化的 第一跖趾关节疾病（MTPJ 1）。这是最常见的形式的关节炎的脚， 50岁以上的人每40人中就有1人受到影响，男女比例为2：1。MTPJ 1发挥着关键作用， 在行走中的功能作用，因为它每走一步都承载着大约119%的体重; 因此，关节疼痛和运动丧失导致活动和生活质量显著降低， 患者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NSAIDs。当这些治疗无效时，可以进行手术。关节固定术（融合术）是一种 但是消除了关节处的运动，导致有限的鞋类选择， 可能会对女性产生重大影响，特别是那些穿着鞋跟高度不同的鞋子的女性。这些 这些限制促使患者寻求避免MTPJ 1运动的替代方案。早期有希望的结果 加强了关于融合与关节保留的争论，但它们的相对安全性和有效性并不 确立了习多关节保留手术包括（1）各种关节成形术，（2）唇切除术， 截骨术和（3）合成软骨植入物。这些更现代的技术还没有与 关节融合术，但一项比较合成软骨植入物与关节融合术的非劣效性试验除外 其报告了2年后疼痛和功能以及植入物失效的相似结果。没有比较 评估唇切除术的试验。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 议案因此，有一个强烈的需求，以确定是否运动备用是同样或更有效的 与关节融合术相比，观察性研究（和 随后的U 01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）使用来自多个中心的观察数据，这些中心采用多个运动保留 手术和关节融合术，以确定是否存在需要单组或 在未来的试验中，多个运动保留治疗组与融合相比，（2）识别HR的相关性 疾病严重程度，使用专家小组对观察数据进行探索性数据分析，以开始 开发和验证一个新的人力资源分类系统的重要过程，（3）进行定性 在随访过程中的不同时间点对现有试点研究患者进行访谈，以确定 结果对他们来说是最重要的，这样我们就可以确保我们在未来的试赛中包括的结果 这些偏好（对于男性和女性来说，它们应该不同），以及（4）设计和计划一个随机的 对照试验或未来的U 01补助金。