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Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) is licensed in Europe for open tibia fractures treated with unreamed nails. However, there is limited data available on the specific use of rhBMP-2 in combination with unreamed nails for open tibia fractures. The intention of the current study was to evaluate the medical and health-economic effects of rhBMP-2 in Gustilo-Anderson grade III open tibia fractures treated with unreamed nails based on individual patient data from two previously published studies. Linear regression analysis was performed on raw data of 90 patients that were either treated by standard of care with soft tissue management and unreamed nailing (SOC group) (n=50) or with rhBMP-2 in addition to soft tissue management and unreamed nailing (rhBMP-2 group) (n=40). For all types of revision, a significant lower percentage of patients (27.5%) of the rhBMP-2 group had to be revised compared to 48% of the patients of the SOC group (p=0.04). When only invasive secondary interventions such as bone grafting and nail exchange were considered, there was also a statistically significant reduction in the rhBMP-2 group with a revision rate of 10.0% (4 of 40 patients) compared to the SOC group with a revision rate of 28.0% (14 of 50 patients) (p=0.01). Mean fracture healing time of 228 days in the rhBMP-2 compared to 266 days in the SOC group was not statistically significant (p=0.24). Health-economic analysis based on a societal perspective with calculation of overall treatment costs after initial surgery and including productivity losses revealed savings of €6,239 per patient for Germany and €4,752 for the UK in favour of rhBMP-2 which was mainly driven by reduction of productivity losses. In conclusion, rhBMP-2 reduces secondary interventions in patients with grade III open tibia fractures treated with an unreamed nail and its use leads to financial savings for Germany and the UK from a societal perspective. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: Early definitive stabilisation is usually the treatment of choice for major fractures in polytrauma patients. Modifications may be made when patients are in critical condition, or when associated injuries dictate the timing of surgery. The current study investigates whether the timing of fracture treatment is different in different trauma systems. Materials and methods: Consecutive patients treated a Level I trauma centre were documented (Group US) and a matched-pair group was gathered from the German Trauma Registry (Group GTR). Inclusion criteria: New Injury Severity Score (NISS)>16, >2 major fractures and >1 organ/soft tissue injury. The timing and type of surgery for major fractures was recorded, as were major complications. Results: 114 patients were included, n =57 Group US (35.1% F, 64.9% M, mean age: 44.1 yrs±16.49, mean NISS: 27.4±8.65, mean ICU stay: 10±7.49) and n =57 Group GTR (36.8% F, 63.1% M, mean age: 41.2 yrs±15.35, mean NISS: 29.4±6.88, mean ICU stay: 15.6±18.25). 44 (57.1%) out of 77 fractures in Group US received primary definitive fracture fixation compared to 61 (65.5%) out of 93 fractures in Group GTR (n.s.). The average duration until definitive treatment was comparable in all major extremity fractures (pelvis: 5 days±2.8 Group US, 7.1 days±9.6 Group GTR (n.s.), femur: 7.9 days±8.3 Group US, 5.5 days±7.9 (n.s.), tibia: 6.2 days±5.6 Group US, 6.2 days±9.1 Group GTR (n.s.), humerus: 5 days±3.7 Group US, 6.6 days±6.1 Group GTR (n.s.), radius: 6 days±4.7 Group US, 6.1 days±8.7 Group GTR (n.s.). Conclusion: The current matched-pair analysis demonstrates that the timing of initial definitive fixation of major fractures is comparable between the US and Europe. Certain fractures are stabilised internally in a staged fashion regardless the trauma system, thus discounting previous apparent contradictions. [Copyright &y& Elsevier]