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）： 半月板撕裂是残疾的常见原因，特别是在伴有膝关节骨关节炎（OA）的患者中。 观察性研究表明，虽然关节镜下部分膝关节切除术（APM）可持续缓解症状并改善症状性膝关节撕裂患者的功能状态，但APM的结局在合并OA的患者中明显更差。尚未有APM在膝关节OA和伴随症状性膝关节撕裂患者中有效性的临床试验。此外，很少有证据表明非手术治疗在这种情况下的疗效。因此，临床医生不确定APM在有症状性膝关节撕裂的OA患者中的短期和长期受益、缺点和适应症。我们提出了一个多中心，随机对照试验APM与标准化的非手术方案在症状性半月板撕裂和并发膝关节OA的患者。试验将在五个优秀的中心进行。该研究有三个具体目标：目标1：进行一项随机对照试验，比较APM与标准化非手术治疗方案在症状性膝关节撕裂和膝关节OA患者中的疗效。 目标二：随访试验队列2年，以确定APM和非手术治疗在疼痛缓解和功能改善方面的差异是否持续2年。目的3：评价APM在治疗膝关节骨关节炎伴症状性关节撕裂患者中的成本-效果。 该试验将提供一个以证据为基础的框架，为有效和具有成本效益的临床管理的踝关节撕裂的设置膝关节OA，其中一个最常见的临床困境，影响了很大一部分的中年和老年人在US.Public Health摘要：超过700，000手术，每年进行的患者谁有症状的踝关节撕裂，谁也有膝关节骨关节炎。目前，临床医生不知道这种手术是否优于非手术治疗。我们提出了一个多中心随机对照试验，严格比较这两种方法。