THE MRC HIP TRIAL: A MULTICENTRE RANDOMISED TRIAL OF ULTRASOUND IMAGING IN INFANTS WITH CLINICAL HIP INSTABILITY DETECTED BY SCREENING.

Abstract

Clinical screening aims to identify and treat infants with neonatal hip instability in order to reduce the risk of subsequent hip displacement but risks failures of diagnosis and treatment (abduction splinting) and potential iatrogenic effects. The Hip Trial aims to assess the clinical effectiveness of ultrasound (US) imaging compared to clinical assessment alone to guide the further management of infants with clinical hip instability.

Infants with clinical hip instability confirmed by a second senior doctor were recruited from 33 UK centres and randomised to standardised US hip examination at age 2–8 weeks [US group: n=314] or clinical assessment alone [no ultrasound (NU) group: n=315. ] Primary outcomes by two years were hip X-ray appearances, operative treatment, abduction, splinting and walking. Analysis was ‘intention to treat’.

Key prognostic factors were similar between the randomised groups. Protocol compliance was high (90% US; 92% NU). X-ray information was available for 91% by 12–14 months and 85% by two years. Fewer children in the US group had abduction splinting in the first two years (RR 0. 78; 95% CI 0. 65–0. 94; p=0. 01). Operative treatment was required by 21 US (6. 7%) and 25 NU (7. 9%) infants (RR 0. 84; 95% CI 0. 48–1. 47. ) By two years, subluxation, dislocation, acetabular dysplasia or avascular necrosis were identified on X-ray on one or both hips of 21 US and 21 NU children (RR 1. 00; 95% CI 0. 56 – 1. 80. ) One US and 4 NU children were not walking by two years (RR 0. 25; exact 95% CI 0. 03–2. 53; p=0. 37)

The use of US imaging in infants with screen-detected clinical hip instability allows abduction splinting rates to be reduced, and is not associated with an increase in abnormal hip development or higher rates of operative treatment by two years of age.