Comparing ankle arthrodesis to ankle arthroplasty

踝关节固定术与踝关节置换术的比较

• 批准号: 8186038
• 负责人: Bruce Sangeorzan
• 金额: $ 57.13万
• 依托单位: SEATTLE INST FOR BIOMEDICAL/CLINICAL RES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8186038
• 关键词: Academy; Address; Affect; American; Ankle; Arthritis; Arthrodesis; Arthroplasty; Attention; Basic Science; Budgets; Case Series; Client satisfaction; Clinical; Clinical Practice Guideline; Clinical Sciences; Cohort Studies; Comparative Study; Data; Degenerative polyarthritis; Development; Enrollment; Failure; Funding; Generations; Gold; Guidelines; Health; Hip region structure; Individual; Insurance Carriers; Knee; Literature; Measures; Modification; Motivation; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Patient Preferences; Patients; Performance; Physical Function; Physical activity; Physicians; Prevalence; Prognostic Factor; Prosthesis; Publishing; Random Allocation; Randomized; Randomized Controlled Trials; Research; Reservations; Safety; Selection for Treatments; Site; Staging; Surgeon; Surgical complication; Techniques; Technology; Time; Training; Treatment Efficacy; Treatment outcome; Work; alternative treatment; ankle joint; base; clinical decision-making; clinically significant; cohort; common treatment; comparative; design; experience; follow-up; functional outcomes; improved; meetings; new technology; parity; patient population; preference; prospective; randomized trial; response; skills; standard care; treatment planning; trial comparing; volunteer

DESCRIPTION (provided by applicant): The purpose of this research is to compare arthrodesis with arthroplasty in the treatment of end stage ankle arthritis (ESAA) via Randomized Controlled Trial (RCT). The absence of this comparative outcome information is crippling the development of clinical guidelines. The American Academy of Orthopaedic Surgeons (AAOS) abandoned plans this year to publish clinical guidelines for treatment of ankle arthritis because of a lack of evidence. Arthrodesis is considered the primary/gold standard treatment in the absence of evidence or quality functional outcome data due to the historical lack of an acceptable surgical alternative. Currently, the treatment selection is based on the training and preference of the surgeon, and the preference of the patient. Only a few prospective cohort studies have compared the safety and efficacy of these treatment options, and no RCTs have been published. Now that a respectable treatment alternative to arthrodesis is available, an RCT is the logical next step. In response to the need for an RCT, the experimental focus of this research is two-fold: 1) to compare arthrodesis versus arthroplasty treatment outcomes in similar patient populations and 2) to identify intrinsic and extrinsic prognostic factors of arthroplasty patients with successful and unsuccessful outcomes for the purpose of establishing clinical indications and contraindications for arthroplasty. This will be accomplished by measuring pain, ankle function, general health, patient satisfaction, and physical activity based on step counts at 3, 6, 12, and 24 months after surgery in a multi-site RCT. It is established that some potential subjects (we estimate 50% based on pilot data) will not want to undergo random allocation where blinding is not possible and one treatment represents relatively new technology; crossover after randomization and demoralization can substantially skew results under these circumstances. The study is powered to answer the primary Specific Aims based on the randomized subjects only, but we will allow those unwilling to randomize to enroll with their preferred treatment choice, and they will be analyzed as part of a Comprehensive Cohort Design. Additional subjects from the Comprehensive Cohort Design will allow us to determine if motivation affects outcome and will provide additional study power to determine which baseline factors are associated with positive and negative outcomes to better determine indications and contraindications for each treatment. To meet the enhanced numbers required to power for the randomized subjects alone, we have increased the number of participating sites from three to five. To assure parity in surgical skill in both treatments, we employ only surgeons with a minimum 5 years experience and performance of at least 30 ankle replacements. To meet budget limitations imposed by adding more sites, the surgeons at these sites have agreed to volunteer the time needed to complete the study. Though there are many issues that can only be answered by a longer study, we expect to answer our stated aims within this follow up. PUBLIC HEALTH RELEVANCE: A dramatic change is taking place in the treatment of end stage ankle arthritis. The advent of successful (in the short term) second generation prosthetic ankle joints is changing the treatment paradigm. Both physicians and patients are in need of good quality evidence comparing arthroplasty to the "gold standard" of arthrodesis to guide treatment. This study should provide this important information and provide data on which patients are better candidates for one treatment over another.

描述（由申请人提供）：本研究的目的是通过随机对照试验（RCT）比较关节融合术与关节成形术治疗终末期踝关节炎（ESAA）的效果。缺乏这种比较结果信息正在阻碍临床指南的制定。由于缺乏证据，美国骨科医师学会 (AAOS) 放弃了今年发布踝关节炎治疗临床指南的计划。由于历史上缺乏可接受的手术替代方案，在缺乏证据或高质量功能结果数据的情况下，关节固定术被认为是主要/金标准治疗。目前，治疗选择是基于外科医生的培训和偏好以及患者的偏好。只有少数前瞻性队列研究比较了这些治疗方案的安全性和有效性，并且尚未发表随机对照试验。既然关节融合术已经有了一种值得尊敬的治疗替代方案，那么随机对照试验就是下一步的逻辑。为了满足随机对照试验的需要，本研究的实验重点有两个：1）比较相似患者群体中关节融合术与关节置换术的治疗结果；2）确定关节置换术成功和不成功患者的内在和外在预后因素目的是确定关节置换术的临床适应症和禁忌症。这将通过在多部位随机对照试验中根据术后 3、6、12 和 24 个月的步数测量疼痛、踝关节功能、总体健康状况、患者满意度和身体活动来实现。已经确定，一些潜在受试者（我们根据试点数据估计 50%）不会希望接受随机分配，因为随机分配是不可能进行盲法且一种治疗代表相对较新的技术；在这些情况下，随机化和士气低落后的交叉可能会严重扭曲结果。该研究仅根据随机受试者来回答主要的具体目标，但我们将允许那些不愿意随机的受试者以他们首选的治疗选择入组，并且他们将作为综合队列设计的一部分进行分析。综合队列设计中的其他受试者将使我们能够确定动机是否影响结果，并将提供额外的研究能力来确定哪些基线因素与积极和消极结果相关，从而更好地确定每种治疗的适应症和禁忌症。为了满足单独为随机受试者供电所需的增加数量，我们将参与站点的数量从三个增加到五个。为了确保两种治疗方法的手术技巧相同，我们仅聘用具有至少 5 年经验且具有至少 30 次踝关节置换术经验的外科医生。为了满足增加更多研究中心所带来的预算限制，这些研究中心的外科医生同意自愿提供完成研究所需的时间。尽管有许多问题只能通过更长期的研究来回答，但我们希望在这次后续行动中回答我们既定的目标。 公共卫生相关性：末期踝关节炎的治疗正在发生巨大变化。成功的（短期内）第二代假肢踝关节的出现正在改变治疗模式。医生和患者都需要高质量的证据来将关节成形术与关节固定术的“金标准”进行比较，以指导治疗。这项研究应该提供这一重要信息，并提供关于哪些患者更适合接受一种治疗而不是另一种治疗的数据。