From the Department of Orthopedics and Traumatology, Hatanpää City Hospital, Tampere (R.S.), the Department of Orthopedics and Traumatology, Helsinki University Central Hospital and University of Helsinki (M.P., J.K., T.L.N.J.), and the National Institute for Health and Welfare, Center for Health and Social Economics (A.M.), Helsinki, the Department of Orthopedics and Traumatology, University of Turku, Turku (A.I.), the Department of Orthopedics, Traumatology, and Hand Surgery, Kuopio University Hospital, Kuopio (A.J.), and the Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä (H.N.) - all in Finland.
N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
BACKGROUND: Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking. METHODS: We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, -1.6 points; 95% confidence interval [CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively). CONCLUSIONS: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.).
背景:关节镜下半月板部分切除术是最常见的矫形手术之一,但缺乏其疗效的严格证据。
方法:我们在 146 名 35 至 65 岁的膝关节症状符合退行性内侧半月板撕裂且无膝关节骨关节炎的患者中进行了一项多中心、随机、双盲、假手术对照试验。患者被随机分配接受关节镜下半月板部分切除术或假手术。主要结局是 Lysholm 和 Western Ontario 半月板评估工具 (WOMET) 评分(每项评分范围为 0 至 100,得分越低表示症状越严重)以及术后 12 个月运动后膝关节疼痛(评分范围为 0 至 10,0 表示无疼痛)的变化。
结果:在意向治疗分析中,任何主要结局从基线到 12 个月的组间差异均无统计学意义。主要结局测量的平均变化(改善)如下:Lysholm 评分,部分切除术组为 21.7 分,假手术组为 23.3 分(组间差异,-1.6 分;95%置信区间 [CI],-7.2 至 4.0);WOMET 评分分别为 24.6 和 27.1 分(组间差异,-2.5 分;95%CI,-9.2 至 4.1);运动后膝关节疼痛评分分别为 3.1 和 3.3 分(组间差异,-0.1;95%CI,-0.9 至 0.7)。部分切除术组有 2 例和假手术组有 5 例需要后续膝关节手术的患者,以及 1 例和 0 例严重不良事件的患者,组间差异无统计学意义。
结论:在这项涉及无膝关节骨关节炎但有退行性内侧半月板撕裂症状的患者的试验中,关节镜下半月板部分切除术的结果并不优于假手术。(由 Sigrid Juselius 基金会等资助;ClinicalTrials.gov 编号,NCT00549172)。
N Engl J Med. 2013-12-26
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