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

描述(由申请人提供)： 半月板撕裂是残疾的常见来源，特别是在伴有膝骨性关节炎(OA)的人中。观察研究表明，尽管关节镜下半月板部分切除术(APM)持续缓解症状并改善半月板撕裂患者的功能状态，但APM的结果在合并OA的患者中明显更差。对于膝关节骨性关节炎并伴随有症状的半月板撕裂的患者，APM的有效性从未进行过临床试验。此外，在这种情况下，几乎没有证据表明非手术治疗的有效性。因此，临床医生不确定APM在有症状的半月板撕裂的OA患者中的短期和长期的益处、缺点和适应症。我们建议对有症状的半月板撕裂和伴随膝骨性关节炎的患者进行APM的多中心随机对照试验和标准化的非手术治疗。试验将在五个优秀的中心进行。本研究有三个具体目的：目的1：进行一项随机对照试验，比较APM与标准化的非手术治疗方案在有症状的半月板撕裂和膝骨性关节炎患者中的疗效。目的2：跟踪试验队列两年，以确定APM和非手术治疗在缓解疼痛和改善功能方面的差异是否持续两年。目的：评价APM治疗膝关节骨性关节炎症状性半月板撕裂的成本-效果。这项试验将为膝骨性关节炎中半月板撕裂的有效和成本效益高的临床治疗提供一个循证框架。膝骨性关节炎是影响美国大部分中老年人的最常见的临床难题之一。公共卫生摘要：每年有超过70万例半月板撕裂症状和膝骨性关节炎的患者接受手术。目前，临床医生还不知道这种手术是否比非手术治疗更好。我们提出了一项多中心随机对照试验来严格比较这两种方法。

DESCRIPTION (provided by applicant): Meniscal tears are frequent sources of disability, especially in persons with concomitant knee osteoarthritis (OA). Observational studies suggest that while arthroscopic partial meniscectomy (APM) consistently relieves symptoms and improves functional status in patients with symptomatic meniscal tear, the outcome of APM is decidedly worse in patients with coexisting OA. There has never been a clinical trial of the effectiveness of APM in patients with knee OA and concomitant symptomatic meniscal tear. Further, there is little evidence on the efficacy of nonoperative management in this setting. Thus, clinicians are uncertain about the short and long term benefits, drawbacks and indications for APM in OA patients with symptomatic meniscal tears. We propose a multicenter, randomized controlled trial of APM versus a standardized nonoperative program in patients with symptomatic meniscal tear and concomitant knee OA. The trial will be carried out in five outstanding centers. The study has three specific aims: Aim 1: To conduct a randomized controlled trial to compare the efficacy of APM versus a standardized non-operative management program among patients with symptomatic meniscal tear and knee OA. Aim 2: To follow the trial cohort for two years in order to determine whether differences between APM and nonoperative therapy in pain relief and functional improvement persist for two years. Aim 3: To evaluate the cost-effectiveness of APM in the management of patients with symptomatic meniscal tears in the setting of knee osteoarthritis. The trial will provide an evidence-based framework for effective and cost-effective clinical management of meniscal tears in the setting of knee OA, one of the most common clinical dilemmas affecting a large proportion of middle-aged and older persons in the US.Public Health Summary: Over 700,000 surgeries are performed each year for patients who have symptoms of a meniscal tear and who also have knee osteoarthritis. Presently, clinicians do not know whether this operation is better than nonoperative therapy. We propose a multicenter randomized controlled trial to rigorously compare these two approaches.