Diagnostic Radiology, Great Ormond Street Hospital for Children, London, United Kingdom.
Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.
We conducted a blinded, randomized, controlled trial to examine whether mildly dysplastic but stable or instable hips would benefit from early treatment, as compared with watchful waiting.
A total of 128 newborns with mild hip dysplasia (sonographic inclination angle [alpha angle] of 43 degrees -49 degrees ) and stable or instable but not dislocatable hips were randomly assigned to receive either 6 weeks of abduction treatment (immediate-treatment group) or follow-up alone (active-sonographic-surveillance group). The main outcome measurement was the acetabular inclination angle, measured by radiograph, at 1 year of age.
Both groups included 64 newborns, and there was no loss to follow-up. With the exception of a small but statistically significant excess of girls in the active-sonographic-surveillance group, there were no statistically significant differences in baseline characteristics between the 2 groups. The mean inclination angle at 12 months was 24.2 degrees for both groups (difference: 0.1 [95% confidence interval (CI): -0.8 to 0.9]), and all children had improved and were without treatment. The mean alpha angle was 59.7 degrees in the treatment group and 57.1 degrees in the active-surveillance group for a difference of 2.6 degrees evaluated after 1.5 and 3 months (95% CI: 1.8 to 3.4; P < .001). At 1.5 months of age, the hips had improved in all treated children but not in 5 children under active surveillance (P = .06). Among the sonographic-surveillance group, 47% received treatment after the initial surveillance period of 1.5 months.
Active-sonographic-surveillance halved the number of children requiring treatment, did not increase the duration of treatment, and yielded similar results at 1-year follow-up. Given a reported prevalence of 1.3% for mildly dysplastic but stable hips, a strategy of active surveillance would reduce the overall treatment rate by 0.6%. Our results may have important implications for families as well as for health care costs.
我们进行了一项盲法、随机、对照试验,以检验对于轻度发育不良但稳定或不稳定的髋关节,早期治疗是否优于密切观察。
共有 128 例新生儿存在轻度髋关节发育不良(超声倾斜角 [α 角] 43°-49°),且髋关节稳定或不稳定但无脱位,将其随机分为接受 6 周外展治疗(即刻治疗组)或单独接受随访(主动超声监测组)。主要观察指标为 1 岁时的髋臼倾斜角(X 线片测量)。
两组各纳入 64 例新生儿,无失访。除主动超声监测组中女孩稍多(但统计学上无显著差异)外,两组间基线特征无统计学显著差异。两组 12 个月时平均倾斜角分别为 24.2°(差异:0.1 [95%置信区间(CI):-0.8 至 0.9]),所有患儿均改善且无需治疗。治疗组的平均 α 角为 59.7°,主动监测组为 57.1°,差异为 2.6°(1.5 个月和 3 个月时的 95%CI:1.8 至 3.4;P<0.001)。1.5 个月时,所有接受治疗的患儿髋关节均改善,但主动监测组 5 例患儿未改善(P=0.06)。在超声监测组中,47%的患儿在最初的 1.5 个月监测期后接受了治疗。
主动超声监测使需要治疗的患儿数量减少了一半,并未增加治疗时间,且 1 年随访时结果相似。对于轻度发育不良但稳定的髋关节,据报道其患病率为 1.3%,主动监测策略可将总体治疗率降低 0.6%。我们的结果可能对家庭以及医疗保健成本具有重要意义。