Treatments for paediatric femoral fractures: a randomised trial

Treatments for femoral fractures in children vary widely and have been investigated only in case series. We did a multicentre randomised trial to compare malunion rates after external fixation and after early application of a hip spica cast for paediatric femoral shaft fractures. All children aged 4–10 years with femoral fractures, admitted to four paediatric hospitals, were randomly assigned early application of hip spica or external fixation. The primary outcome was malunion at 2 years after the fracture. Secondary outcomes were scores on the RAND physical function child health questionnaire and the post-hospitalisation behavioural questionnaire, and parents' and children's ratings of overall satisfaction with treatment. Analysis was by intention to treat based on children who reached the 2 year evaluation. Of 60 children assigned to the hip-spica group, 56 reached the 2-year assessment; of them, six (11%) required other forms of treatment because of unacceptable loss of reduction. Of 48 children assigned external fixation, 45 reached the 2-year assessment; two (4%) had refractures and five (11%) required operative adjustment of the fixator. The rate of malunion was significantly higher in the hip-spica group than in the external-fixator group (25/56 [45%] vs 7/45 [16%]; 95% CI for difference 12–46%; p=0·002). The two groups had similar mean scores for the RAND physical function health questionnaire (0·34 vs 0·45; 95% CI for difference, −0·57 to 0·34; p=0·61), for the post-hospitalisation questionnaire (106·8 vs 106·3; −4·9 to 5·9; p=0·86), and for parents' satisfaction (4·3 vs 4·2; −0·3 to 0·6; p=0·5) and children's ratings of happiness with treatment (6·9 vs 7·7; −2·2 to 0·5; p=0·21). Early application of hip spica has a small role in the treatment of paediatric femoral fractures. Future trials need to compare external fixation with flexible intramedullary nails.