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Treatments for paediatric femoral fractures: a randomised trial
Wright JG, Wang EEL, Owen JL, Stephens D, Graham HK, Hanlon M, Nattrass GR, Reynolds RA, Coyte P
Lancet 2005 Mar 26-Apr 1;365(9465):1153-1158
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 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%) versus 7/45 (16%); 95% CI for difference 12 to 46%; p = 0.002). The two groups had similar mean scores for the RAND physical function health questionnaire (0.34 versus 0.45; 95% CI for difference, -0.57 to 0.34; p = 0.61), for the post-hospitalisation questionnaire (106.8 versus 106.3; -4.9 to 5.9; p = 0.86), and for parents' satisfaction (4.3 versus 4.2; -0.3 to 0.6; p = 0.5) and children's ratings of happiness with treatment (6.9 versus 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.

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