Comparing ankle arthrodesis to ankle arthroplasty

描述（由申请人提供）：本研究的目的是通过随机对照试验（RCT）比较关节融合术和关节置换术治疗终末期踝关节关节炎（ESAA）的疗效。这种比较结果信息的缺乏削弱了临床指南的发展。由于缺乏证据，美国骨科医师学会（AAOS）今年放弃了发表治疗踝关节关节炎临床指南的计划。由于历史上缺乏可接受的手术选择，在缺乏证据或高质量功能结果数据的情况下，关节融合术被认为是主要/金标准治疗。目前，治疗方案的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，并且没有发表随机对照试验。现在有了一种值得尊敬的替代关节融合术的治疗方法，RCT是合乎逻辑的下一步。为了响应随机对照试验的需要，本研究的实验重点有两个方面：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，以确定关节置换术的临床适应症和禁忌症。这将通过在术后3、6、12和24个月的多点随机对照试验中测量疼痛、踝关节功能、一般健康状况、患者满意度和基于步数的身体活动来完成。可以确定的是，一些潜在的受试者（我们根据试点数据估计50%）不希望进行随机分配，因为盲法是不可能的，而且一种治疗方法代表了相对较新的技术；在这种情况下，随机化和士气低落之后的交叉会严重扭曲结果。该研究仅在随机受试者的基础上回答了主要的特定目标，但我们将允许那些不愿意随机分组的患者选择他们喜欢的治疗方案，他们将作为综合队列设计的一部分进行分析。来自综合队列设计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力量来确定哪些基线因素与阳性和阴性结果相关，以更好地确定每种治疗的适应症和禁忌症。为了满足随机受试者单独供电所需的增加数量，我们将参与站点的数量从3个增加到5个。为了确保两种治疗方法的手术技巧相同，我们只雇用至少有5年经验和至少30次踝关节置换的外科医生。为了满足增加更多地点所带来的预算限制，这些地点的外科医生同意自愿完成研究所需的时间。虽然有许多问题只能通过更长的研究来回答，但我们希望在这次后续研究中回答我们的既定目标。

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.