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: 7932451
• 负责人: Jeffrey Neil Katz
• 金额: $ 17万
• 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: 2009-09-23 至 2011-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7932451
• 关键词: 1 year old; Address; Affect; Aftercare; Arthroscopic Surgical Procedures; Arthroscopy; Clinical; Clinical Management; Clinical Trials; Debridement; Degenerative polyarthritis; Disease; Elderly; Employee Strikes; Epidemiologist; Goals; Health; Injury; Irrigation; Knee; Knee Osteoarthritis; Lesion; Mechanics; Medical; Observational Study; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Patients; Persons; Population; Procedures; Prognostic Factor; Publishing; Randomized; Randomized Controlled Trials; Reporting; Research; Resources; Role; Source; Suggestion; Surgeon; Symptoms; cohort; comparative efficacy; cost; cost effectiveness; disability; effectiveness clinical trial; evidence base; experience; follow-up; functional improvement; functional loss; functional status; improved; middle age; multidisciplinary; programs; rheumatologist; sham surgery

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.

描述（由申请人提供）： 半月板眼泪是经常出现的残疾来源，尤其是在伴有膝关节骨关节炎（OA）的患者中。 观察性研究表明，虽然关节镜部分半月板切除术（APM）始终缓解症状并改善有症状的半月板撕裂患者的功能状态，但在共存OA的患者中，APM的结果肯定会更糟。从未有过关于APM在膝关节OA患者和伴随症状的半月板撕裂患者中的有效性的临床试验。此外，在这种情况下非手术管理的功效几乎没有证据。因此，临床医生不确定有症状的半月板撕裂的OA患者的短期和长期益处，缺点和适应症。我们提出了一项APM的多中心，随机对照试验与有症状的半月板撕裂和伴随膝关节OA患者的标准非手术计划。该审判将在五个出色的中心进行。这项研究具有三个具体的目的：目标1：进行随机对照试验，以比较APM的功效与有症状的半月板撕裂和膝盖OA患者中的标准化非手术管理计划。 AIM 2：遵循试验队列两年，以确定APM和非手术治疗之间的差异是否在疼痛缓解和功能改善方面是否持续了两年。 AIM 3：评估APM在膝关节骨关节炎的情况下患有症状的半月板撕裂患者的管理成本效益。 该试验将提供一个基于证据的框架，用于在膝盖OA的环境中对半月板泪水进行有效且具有成本效益的临床管理，这是美国最常见的临床困境之一，影响了美国的大量中年和老年人。公共健康摘要：每年超过700,000个手术，对同样患有骑士症状的患者进行了700,000个手术。目前，临床医生不知道该手术是否比非手术治疗更好。我们建议一项多中心随机对照试验，以严格比较这两种方法。