Beckmann James T, Wylie James D, Potter Michael Q, Maak Travis G, Greene Thomas H, Aoki Stephen K
Department of Orthopaedic Surgery, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
Department of Population Health Sciences and Internal Medicine, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108.
J Bone Joint Surg Am. 2015 Dec 16;97(24):2032-7. doi: 10.2106/JBJS.N.01156.
Heterotopic ossification (HO) is a known complication of hip arthroscopy. Our objective was to determine the effect of postoperative naproxen therapy on the development of HO following arthroscopic surgery for femoroacetabular impingement.
Between August 2011 and April 2013, 108 eligible patients were enrolled and randomized to take naproxen or a placebo for three weeks postoperatively. Radiographs were made at routine follow-up visits for one year following surgery. The primary outcome measure was the development of HO, as classified with the Brooker criteria and two-dimensional measurements on radiographs made at least seventy-five days postoperatively (average, 322 days). The primary analysis, performed with a Fisher exact test, compared the proportion of subjects with HO between the treatment and control groups. A single a priori interim analysis was planned at the midpoint of the study.
Our data safety and monitoring board stopped this study when the interim analysis showed that the stopping criterion had been met for demonstration of efficacy of the naproxen intervention. The prevalence of HO was 46% (twenty-two of the forty-eight in the final analysis) in the placebo group versus 4% (two of forty-eight) in the naproxen group (p < 0.001). Medication compliance was 69% overall, but it did not differ between the naproxen and placebo groups. Minor adverse reactions to the study medications were reported in 42% of the patients taking naproxen versus 35% of those taking the placebo (p = 0.45).
In this trial, prophylaxis with naproxen was effective in reducing the prevalence of HO without medication-related morbidity.
异位骨化（HO）是髋关节镜手术已知的并发症。我们的目的是确定术后萘普生治疗对股骨髋臼撞击症关节镜手术后HO发生的影响。
在2011年8月至2013年4月期间，108例符合条件的患者被纳入研究并随机分为术后服用萘普生或安慰剂3周。术后一年的常规随访时拍摄X光片。主要结局指标是HO的发生情况，根据布鲁克标准分类，并在术后至少75天（平均322天）拍摄的X光片上进行二维测量。主要分析采用Fisher精确检验，比较治疗组和对照组中发生HO的受试者比例。在研究中点计划进行一次先验中期分析。
当期中分析显示萘普生干预疗效的停止标准已满足时，我们的数据安全监测委员会停止了这项研究。安慰剂组HO的患病率为46%（最终分析中48例中有22例），而萘普生组为4%（48例中有2例）（p<0.001）。总体药物依从性为69%，但萘普生组和安慰剂组之间没有差异。服用萘普生的患者中有42%报告了对研究药物的轻微不良反应，而服用安慰剂的患者中这一比例为35%（p = 0.45）。
在本试验中，萘普生预防可有效降低HO的患病率，且无药物相关的发病率。
