1 Department of Business and Economics, Faculty of Business and Social Sciences, SDU2 Research Programme on Health and Morbidity in Denmark, National Institute of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU3 unknown4 Health Promotion and Prevention, National Institute of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU5 Department of Business and Economics, Faculty of Business and Social Sciences, SDU6 Health Promotion and Prevention, National Institute of Public Health, Det Sundhedsvidenskabelige Fakultet, SDU
similar treatment time for tension-band plating and for stapling: a randomized clinical trial on guided growth for idiopathic genu valgum
BACKGROUND: In children with angulating deformities of the lower limbs, hemiepiphysiodesis can be used to guide growth to achieve better alignment at skeletal maturity. Traditionally, this has been performed with staples. The tension-band plating technique is new and it has been advocated because it is believed to reduce the risk of premature closure of the growth plate compared to stapling. The benefit of the tension-band plating technique has not yet been proven in experimental or randomized clinical studies. METHODS: We performed a randomized clinical trial in which 26 children with idiopathic genu valgum were allocated to stapling or tension-band plating hemiepiphysiodesis. Time to correction of the deformity was recorded and changes in angles on long standing radiographs were measured. Pain score using visual analog scale (VAS) was recorded for the first 72 h postoperatively. Analgesics taken were recorded by the parents. RESULTS: Mean treatment times for stapling hemiepiphysiodesis (n = 10) and for tension-band plating hemiepiphysiodesis (n = 10) were similar. Postoperative VAS scores and consumption of analgesics were also similar in both groups. No hardware failure or wound-related infection was observed. INTERPRETATION: Treatment time for the 2 treatment modalities was not significantly different in this randomized clinical trial. Tension-band plating and stapling appeared to have a similar effect regarding correction of genu valgum. We cannot rule out type-II error and the possibility that our study was underpowered. ClinicalTrials.gov Identifier: NCT01641354.