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

部分半月板切除术与非手术治疗。

• 批准号: 7813697
• 负责人: Jeffrey Neil Katz
• 金额: $ 137.22万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2013-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7813697
• 关键词: 1 year old; 3-Dimensional; Address; Affect; American; Bone Marrow; Boston; Cartilage; Clinical; Clinical Data; Communities; Couples; Data; Databases; Degenerative polyarthritis; Disease; Edema; Enrollment; Excision; Face; Funding; Goals; Image; Incidence; Knee; Knee Osteoarthritis; Lead; Lesion; Life; Long-Term Effects; MRI Scans; Magnetic Resonance Imaging; Measures; Meteor; Observational Study; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Pain management; Patients; Persons; Policy Maker; Procedures; Questionnaires; Randomized; Reading; Research; Resolution; Resources; Risk Factors; Specific qualifier value; Surgeon; Surgical Management; Symptoms; System; Uncertainty; Upper arm; cost effectiveness; design; evidence base; functional improvement; functional status; impression; improved; morphometry; repository

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.

描述（由申请人提供）：骨关节炎（OA）影响了2700万美国人，其中许多人伴有症状性关节撕裂。关节镜下部分椎间盘切除术（APM）是用于治疗这些患者时，保守措施不成功的外科手术。APM在OA患者中的疗效尚未进行严格研究。先前的研究已经提出了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，临床社区面临着APM的短期疗效及其对症状性结膜撕裂和OA患者的长期影响的不确定性。 目前资助的目标：资助MeTeOR试验的目的是：1）确定APM是否在6个月内提供了比非手术治疗更大的疼痛缓解和功能改善; 2）对受试者进行两年随访，以确定短期是否持续; 3）检查APM治疗症状性膝关节撕裂和膝关节OA患者的成本效益。 竞争性修订的目的：申报的修订解决了APM是否加速OA结构进展的关键问题，与非手术治疗相比。它还检查了结构参数进展的临床意义。这些目标导致了四个具体目标：1.从研究入组后18个月获得受试者的X线片和MRI研究以及问卷调查数据。2.对X线片和MRI扫描进行标准化判读，X线片采用Kelling-Lawrence分级，MRI采用半定量Boston利兹膝关节骨性关节炎评分（BLOKS）系统和定量三维软骨形态测量。3.开发一个整合的MeTeOR数据库，将临床数据与纵向（基线和18个月）X线片和MRI研究的集中存储库结合起来，以便为分析两个试验组之间OA进展率的差异做准备。4.建立评价者间和评价者内影像学检查结果的可靠性以及对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患者尿道撕裂的短期受益和长期影响。