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: 8322052
• 负责人: Bruce Sangeorzan
• 金额: $ 47.61万
• 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 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8322052
• 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; Pain intensity; Pain interference; 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.

描述（由申请人提供）：本研究的目的是通过随机对照试验（RCT）比较关节固定术与关节置换术治疗终末期踝关节炎（ESAA）的效果。这种比较结果信息的缺乏正在削弱临床指南的发展。由于缺乏证据，美国矫形外科学会（AAOS）今年放弃了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局数据的情况下，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，尚未发表RCT。现在，一个值得尊敬的治疗替代关节融合术是可用的，随机对照试验是合乎逻辑的下一步。为了响应RCT的需求，本研究的实验重点是两个方面：1）在相似患者人群中比较关节固定术与关节成形术治疗结局; 2）确定具有成功和不成功结局的关节成形术患者的内在和外在预后因素，以确定关节成形术的临床适应症和禁忌症。这将通过在多中心RCT中基于术后3、6、12和24个月的步数测量疼痛、踝关节功能、一般健康状况、患者满意度和体力活动来实现。已经确定，一些潜在受试者（我们根据初步研究数据估计为50%）不希望接受随机分配，因为不可能设盲，一种治疗代表相对较新的技术;在这些情况下，随机化和道德败坏后的交叉可能会严重扭曲结果。本研究仅基于随机化受试者有把握回答主要特定目的，但我们将允许不愿意随机化的受试者入组其首选治疗选择，并将其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额外受试者将使我们能够确定动机是否影响结局，并将提供额外的研究把握度来确定哪些基线因素与阳性和阴性结局相关，以更好地确定每种治疗的适应症和禁忌症。为了满足仅随机化受试者的把握度所需的增加数量，我们将参与研究中心的数量从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次踝关节置换术的外科医生。为了满足增加更多临床试验机构所带来的预算限制，这些临床试验机构的外科医生同意自愿提供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，但我们希望在此后续行动中回答我们的既定目标。