Partial meniscectomy vs. nonoperative mgmt. in meniscal tear with OA: an RCT

描述（由申请人提供）：半月板是膝关节内的纤维软骨结构，经常随着年龄的增长而撕裂。半月板撕裂发生在三分之一的50岁以上的个体和80%的膝骨关节炎（OA）患者中。这些眼泪绝大多数是无症状的。患者报告的半月板撕裂手术和非手术治疗的结果研究很少。手术（关节镜下半月板部分切除术；APM）似乎与加速骨关节炎有关，但尚不清楚真正的危险因素是手术本身还是潜在的半月板病变。2007年，我们获得了NIAMS的5年资助，开展MeTeOR试验（半月板撕裂在骨关节炎研究中的应用）。MeTeOR的目的是确定在入组后6个月和24个月，与非手术治疗相比，APM是否能改善半月板撕裂和骨关节炎改变患者的功能状态。MeTeOR试验于2011年8月在7个中心随机抽取了351名受试者，完成了入组。超过24个月的持续随访对于确定手术是否导致疼痛和功能的长期改善以及手术是否与加速结构进展独立相关至关重要。更根本的是，还没有对有症状的半月板撕裂和骨关节炎改变的个体进行纵向、全面的研究。需要继续对该队列进行随访，以确定这些患者的症状、功能和结构进展的预测因素。我们提出了以下具体目标：1)在5年随访中，描述手术和非手术治疗的流星患者膝关节疼痛和功能状态的变化，并确定随着时间的推移，每种治疗的早期反应和最大损失的相关因素；2)在5年随访中表征软骨损伤的进展，并确定与更快进展相关的因素；3)对半月板撕裂合并OA患者进行APM与非手术治疗的5年及患者剩余生命的成本-效果分析。我们将通过每6个月对受试者进行问卷调查，直至5年的随访来实现这些目标。在5年的随访后，我们还将获得所有患者受影响膝关节的标准化磁共振成像研究和x线平片。MeTeOR试验队列的延长随访提供了一个理想的机会来评估APM的成功和成本效益，并更广泛地解决数百万症状性半月板撕裂和骨关节炎患者管理中的关键问题。

DESCRIPTION (provided by applicant): The menisci are fibrocartilaginous structures in the knee that frequently tear with age. Meniscal tears occur in one third of individuals over 50 years old and in 80% of patients with knee osteoarthritis (OA). The vast majority of these tears are asymptomatic. The patient-reported outcomes of surgical and nonoperative therapy for meniscal tear are poorly studied. Surgery (arthroscopic partial meniscectomy; APM) appears to be associated with accelerated osteoarthritis, but it is unclear whether the true risk factor is surgey per se or the underlying meniscal lesion. In 2007, we received 5-year funding from NIAMS to conduct the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research). The goal of MeTeOR was to establish whether APM leads to better functional status than nonoperative treatment of patients with meniscal tear and osteoarthritic changes 6 and 24 months following enrollment. The MeTeOR trial completed enrollment in August 2011 by randomizing 351 subjects in seven centers. Continued follow-up beyond 24 months is critical to determine whether surgery results in longer-term improvement in pain and function and whether surgery is independently associated with accelerated structural progression. More fundamentally, there have been no longitudinal, comprehensive studies of individuals with symptomatic meniscal tear and osteoarthritis changes. Continued follow-up of this cohort is needed to identify predictors of symptomatic, functional and structural progression in these patients. We propose the following specific aims: 1) Characterize changes in knee pain and functional status in operatively and nonoperatively treated MeTeOR patients over 5-year follow-up and identify factors associated with early response and with greatest loss of response to each treatment over time; 2) Characterize progression of cartilage damage over 5-year follow-up and identify factors associated with more rapid progression; 3) Conduct a cost-effectiveness analysis of APM compared with nonoperative therapy in patients with meniscal tear and concomitant OA over the 5-year time frame and over the remainder of patients' lives. We will achieve these aims by administering questionnaires to subjects every 6 months through 5 year follow- up. We will also obtain standardized magnetic resonance imaging studies and plain radiographs of the affected knee on all patients after 5 years of follow-up. The extended follow-up of the MeTeOR trial cohort provides an ideal opportunity to assess the success and cost effectiveness of APM and more generally to address key questions in the management of millions of people with symptomatic meniscal tear and osteoarthritis.