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% C1 for difference 12-46%; p=O center dot 002). The two groups had similar mean scores for the RAND physical function health questionnaire (0 center dot 34 vs 0 center dot 45; 95% Cl for difference, -0 center dot 57 to 0 center dot 34; p=O center dot 61), for the post-hospitalisation questionnaire (106 center dot 8 vs 106 center dot 3; -4 center dot 9 to 5 center dot 9; p=O center dot 86), and for parents' satisfaction (4 center dot 3 vs 4 center dot 2; -0 center dot 3 to 0 center dot 6; p=O center dot 5) and children's ratings of happiness with treatment (6 center dot 9 vs 7 center dot 7; -2 center dot 2 to 0 center dot 5; p=O center dot 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.