title: Effects of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III open tibia fractures treated with unreamed nails-A clinical and health-economic analysis.
abstract: 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.
authors.affiliation: Department of Trauma, Hand and Reconstructive Surgery Giessen University Hospital Giessen-Marburg, Campus Giessen, Rudolf-Buchheim-Str. 7, 35385, Giessen, Germany. Electronic address: volker.alt@chiru.med.uni-giessen.de.
authors.forename: Volker
authors.initials: V
authors.lastname: Alt
authors.affiliation: Medtronic Sàrl, Tolochenaz, Switzerland.
authors.forename: Benny
authors.initials: B
authors.lastname: Borgman
authors.affiliation: Department of Trauma, Hand and Reconstructive Surgery Giessen University Hospital Giessen-Marburg, Campus Giessen, Rudolf-Buchheim-Str. 7, 35385, Giessen, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Eicher
authors.affiliation: Department of Trauma, Hand and Reconstructive Surgery Giessen University Hospital Giessen-Marburg, Campus Giessen, Rudolf-Buchheim-Str. 7, 35385, Giessen, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Heiss
authors.affiliation: Leeds Teaching Hospitals NHS Trust Academic Department of Trauma and Orthopaedics School of Medicine, University of Leeds, UK.
authors.forename: Nikolaos K
authors.initials: NK
authors.lastname: Kanakaris
authors.affiliation: Leeds Teaching Hospitals NHS Trust Academic Department of Trauma and Orthopaedics School of Medicine, University of Leeds, UK.
authors.forename: Peter V
authors.initials: PV
authors.lastname: Giannoudis
authors.affiliation: Research Synthesis and Health Service Research, Faculty of Health, University of East Anglia, Norwich NR4 7SY, UK.
authors.forename: Fujian
authors.initials: F
authors.lastname: Song
mesh_terms: D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000191:economics / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D005594:Fracture Fixation, Intramedullary / Q000191:economics*; D017102:Fracture Healing; D005597:Fractures, Open / Q000191:economics / Q000628:therapy*; D005858:Germany / Q000453:epidemiology; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D012086:Reoperation / Q000191:economics; D013978:Tibial Fractures / Q000191:economics / Q000628:therapy*; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins
keywords: BMP-2; Fracture; Health economics; Tibia