Treatments for paediatric femoral fractures: A randomised trial

Background: 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. Methods: 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. Findings: 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). Interpretation: 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.