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

描述（由申请人提供）：骨关节炎（OA）影响2700万美国人，其中许多人伴有症状性半月板撕裂。当保守措施不成功时，关节镜半月板部分切除术（APM）是用于治疗这些患者的外科手术。APM在OA患者中的疗效尚未得到严格的研究。先前的研究提出了APM可能与OA加速进展相关的担忧，然而这些研究没有使用适当的对照。因此，对于有症状的半月板撕裂和OA患者，APM的短期疗效和长期效果，临床界都面临着不确定性。目前资助的目的：MeTeOR试验的资助目的是：1)确定与非手术治疗相比，APM是否在6个月内提供更大的疼痛缓解和功能改善；2)对受试者进行为期两年的随访，以确定短期是否持续；3)检验APM治疗症状性半月板撕裂和膝关节OA患者的成本-效果。竞争性修订的目的：拟议的修订解决了与非手术治疗相比APM是否加速OA结构进展的关键问题。它还检查了结构参数进展的临床意义。这些目标导致四个具体目标：1。获得研究对象入组后18个月的x光片和MRI研究以及问卷调查数据。2.使用Kellgren-Lawrence分级x线片、半定量Boston Leeds骨关节炎膝关节评分（BLOKS）评分系统和定量MRI三维软骨形态测量法对x线片和MRI扫描进行标准化读数。3.开发一个集成的MeTeOR数据库，将临床数据与纵向（基线和18个月）x线片和MRI研究的集中存储库相结合，以便为分析两个试验组之间OA进展率的差异做准备。4.建立影像学发现之间和内部的可靠性以及影像学参数变化的临床解释。研究活动将建立证据，告知临床医生和政策制定者APM和非手术治疗OA患者半月板撕裂的短期效益和长期影响。

DESCRIPTION (provided by applicant): Osteoarthritis (OA) affects 27 million Americans, many of whom have concomitant symptomatic meniscal tear. Arthroscopic partial meniscectomy (APM) is the surgical procedure used to treat these patients when conservative measures are not successful. The efficacy of APM in patients with OA has not been studied rigorously. Prior studies have raised the concern that APM may be associated with accelerated progression of OA, however these studies have not used appropriate controls. Thus the clinical community faces uncertainty both about the short term efficacy of APM and its longer term effects in patients with symptomatic meniscal tear and OA. Currently funded aims: The MeTeOR Trial was funded to 1) establish whether APM provides greater pain relief and functional improvement over six months as compared with nonoperative therapy; 2) follow subjects for two years to ascertain whether short-term are sustained; and 3) examine the cost- effectiveness of APM for patients with symptomatic meniscal tear and knee OA. Aims of the Competitive Revision: The proposed revision addresses the crucial question of whether APM accelerates structural progression of OA compared to non-surgical management. It also examines the clinical meaning of progression in structural parameters. These objectives lead to four Specific Aims: 1.To obtain radiographs and MRI studies as well as questionnaire data from subjects at 18 months from study enrollment. 2.To conduct standardized readings of the radiographs and MRI scans using Kellgren-Lawrence grading for radiographs and the semi-quantitative Boston Leeds Osteoarthritis Knee Score (BLOKS) scoring system and quantitative 3-D cartilage morphometry for MRI. 3.To develop an integrated MeTeOR database that couples clinical data with a centralized repository of longitudinal (baseline and 18 month) radiographs and MRI studies in order to prepare for analyses of differences in rates of OA progression between the two trial arms. 4.To establish the inter- and intra-rater reliability of imaging findings and clinical interpretation of changes in imaging parameters. The study activities will build the evidence to inform clinicians and policy makers of short-term benefits and longer term effects of APM and nonoperative management of meniscal tears in patients with OA.