跳至主要内容
临床试验/NCT01866527
NCT01866527已完成不适用

Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.

University of Bergen1 个研究点 分布在 1 个国家目标入组 81,564 人开始时间: 1991年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81,564
试验地点
1
主要终点
late dislocated or subluxated hips

研究概览

简要总结

Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme.

All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of DDH, were subjected to US screening at age one to three days. Severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. The minimum observation period was 5,5 years.

详细描述

Of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. Of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. Another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. Twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). Another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. Thirty-one children (0,38 per 1000) had surgical treatment before age five years. Avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment.

Interpretation The first 16 years of a standardised selective US screening programme for DDH resulted in acceptable rates of early treatment and US follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • born at Haukeland University hospital January 1991-December 2006

排除标准

  • Children with DDH due to neuromuscular syndromes were excluded.

结局指标

主要结局

late dislocated or subluxated hips

时间窗: first 5 years of life

late detected after 1 month of life, requiring treatment

次要结局

  • Number of participants who receive ultrasound follow-up for 6 weeks or more(first months of life)
  • early treatment(first months of life)
  • first surgical treatment(first five years of life)
  • avascular necrosis of femoral head(first five years of life)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lene Bjerke Laborie

MD

University of Bergen

研究点 (1)

Loading locations...

相似试验

Selective Ultrasound Screening for DDH 1991-2006 | 临床试验