Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA.
N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18.
BACKGROUND: Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain. METHODS: We conducted a multicenter, randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and evidence of mild-to-moderate osteoarthritis on imaging. We randomly assigned 351 patients to surgery and postoperative physical therapy or to a standardized physical-therapy regimen (with the option to cross over to surgery at the discretion of the patient and surgeon). The patients were evaluated at 6 and 12 months. The primary outcome was the difference between the groups with respect to the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) 6 months after randomization. RESULTS: In the intention-to-treat analysis, the mean improvement in the WOMAC score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5). At 6 months, 51 active participants in the study who were assigned to physical therapy alone (30%) had undergone surgery, and 9 patients assigned to surgery (6%) had not undergone surgery. The results at 12 months were similar to those at 6 months. The frequency of adverse events did not differ significantly between the groups. CONCLUSIONS: In the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; METEOR ClinicalTrials.gov number, NCT00597012.).
背景:对于有半月板撕裂和膝关节骨关节炎症状的患者,关节镜下半月板部分切除术是否比非手术治疗能带来更好的功能结果尚不确定。
方法:我们开展了一项多中心、随机、对照试验,纳入了有半月板撕裂和影像学显示轻度至中度骨关节炎证据的 45 岁及以上有症状的患者。我们将 351 名患者随机分配到手术和术后物理治疗组或标准化的物理治疗方案组(患者和外科医生可自行决定选择交叉手术)。患者在 6 个月和 12 个月时接受评估。主要结局是两组之间在随机分组后 6 个月时 Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)身体功能评分(范围 0 至 100 分,分数越高表明症状越严重)的变化差异。
结果:在意向治疗分析中,手术组在 6 个月时 WOMAC 评分的平均改善为 20.9 分(95%置信区间 [CI],17.9 至 23.9),物理治疗组为 18.5 分(95% CI,15.6 至 21.5)(平均差异,2.4 分;95% CI,-1.8 至 6.5)。在 6 个月时,单独接受物理治疗的 51 名积极研究参与者(30%)已接受手术,而 9 名接受手术的患者(6%)未接受手术。12 个月时的结果与 6 个月时相似。两组间不良事件的发生频率无显著差异。
结论:在意向治疗分析中,我们未发现随机分组后 6 个月时两组间功能改善存在显著差异;然而,单独接受物理治疗的患者中有 30%在 6 个月内接受了手术。(由美国国立关节炎、肌肉骨骼和皮肤病研究所资助;METEOR ClinicalTrials.gov 编号,NCT00597012。)
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