Immediate Treatment Compared With Active Sonographic Surveillance in the Management of Mild Hip Dysplasia in Newborn Infants: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- The acetabular index (AI), assessed from anterior-posterior pelvic radiographs obtained according to a standardized protocol at age 12 months
研究概览
简要总结
Developmental dysplasia of the hip is the most common musculoskeletal disorder in infancy, with a reported prevalence of 2% of all newborns. Although newborn screening programs based on clinical examination with Ortolani and Barlow tests were introduced in the 1950's and 1960's with early abduction splinting of the 2% testing positive, the prevalence of late cases warranting surgery has remained stable, around one per 1000. This has led to the introduction of ultrasound as an additional diagnostic tool, resulting in treatment rates of until 5-6%. This three fold increase in abduction splinting treatment is partly due to the initiation of treatment of infants in whom mild hip dysplasia but no hip instability has been identified. The benefit of early treatment of mild dysplasia in a hip that is neither dislocated nor dislocatable is unclear. Further, abduction splinting is not without risk, with avascular necrosis being reported in around 1%. The investigators conducted a masked, randomized, controlled trial to examine whether mildly dysplastic but stable or instable hips would benefit from early treatment, as compared to watchful waiting.
详细描述
140 newborns with stable (not dislocatable or dislocated) but mildly dysplastic hips, born at the Maternity Hospital, Haukeland University Hospital, from 1997 onwards.
The newborns will be randomly assigned to one of two groups (number in sealed envelope, see flow chart). Because the newborns are recruited from a high risk group (60% with a positive family history and 35% breech), these risk factors are considered to be equally distributed in the two study groups. Stratification is therefore considered unnecessary.
For the controls, treatment will be started at age 1.5 months in cases of persistent dysplasia, i.e. a α-angle <50º, while treatment will be continued in the treatment group if the α-angle is ≤53º. At 3 months, treatment will be discontinued if the α-angle is ≥55º or started if α-angle is<55º. Treatment continued beyond 3 months will be discontinued when the AI is within two standard deviations according to the reference values from Tönnis and Brunken.
The study will require randomisation of 128 subjects into two equally sized groups to obtain 80% statistical power to detect a 3º difference of the α-angle. Less than 128 infants will be required to detect a similar difference in AI on radiography. To compensate for an expected rate of ineligibility and loss to follow-up of up to ten per cent, 140 patients will be enrolled.
PRACTICAL ISSUES The clinical hip-examinations will be performed at the maternity ward during day 1-3, by a physician with at least 2 years of pediatric experience. The hip joints will be classified as stable, unstable, dislocatable or dislocated. TM has the responsibility for the clinical re-examination prior to enrollement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight > 2500 g
- •Mild hip dysplasia on ultrasound day 1-2
- •Written informed consent given
排除标准
- •Birth weight less than 2500 g and/or severe congenital malformation(s)
结局指标
主要结局
The acetabular index (AI), assessed from anterior-posterior pelvic radiographs obtained according to a standardized protocol at age 12 months
时间窗: 12 months
次要结局
- We also report the proportion of children requiring treatment in the first year of life and its duration, and the proportion of children in each group with radiological ossification delay or dysplasia at one year of age.(12 months)