Moseley J Bruce, O'Malley Kimberly, Petersen Nancy J, Menke Terri J, Brody Baruch A, Kuykendall David H, Hollingsworth John C, Ashton Carol M, Wray Nelda P
Houston Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX 77030, USA.
N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee.
A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial.
At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference.
In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
许多患者报告称，接受膝关节骨关节炎关节镜检查后症状得到缓解，但尚不清楚该手术是如何达到这一效果的。我们进行了一项随机、安慰剂对照试验，以评估关节镜检查治疗膝关节骨关节炎的疗效。
总共180例膝关节骨关节炎患者被随机分配接受关节镜清理术、关节镜冲洗术或安慰剂手术。安慰剂组患者接受皮肤切口，并在不插入关节镜的情况下进行模拟清理术。患者和结果评估者对治疗组分配情况不知情。在24个月期间的多个时间点，使用五项自我报告评分（三项疼痛评分和两项功能评分）以及一项步行和爬楼梯客观测试对结果进行评估。共有165例患者完成了试验。
在任何时间点，两个干预组报告的疼痛减轻程度或功能改善情况均不比安慰剂组更好。例如，在膝关节特异性疼痛量表（范围为0至100，分数越高表明疼痛越严重）上，安慰剂组、冲洗组和清理组的平均（±标准差）得分在一年时相似，分别为48.9±21.9、54.8±19.8和51.7±22.4（安慰剂组与冲洗组比较，P = 0.14；安慰剂组与清理组比较，P = 0.51），在两年时分别为51.6±23.7、53.7±23.7和51.4±23.2（P分别为0.64和0.96）。此外，安慰剂组与干预组之间差异的95%置信区间排除了任何具有临床意义的差异。
在这项涉及膝关节骨关节炎患者的对照试验中，关节镜冲洗术或关节镜清理术的结果并不比安慰剂手术更好。
