Short term results with the use of PLA antibiotic coated nail in open tibia fractures: A prospective study

Abstract

BackgroundAntibiotic impregnated cement coated nails have been described in literature with promising success rates. However, they need removal at a later stage. This study focuses on use of a PLA-precoated antibiotic nail that stops eluting antibiotic after a while and can be retained later as it behaves as a standard interlocking nail in the long run. PurposeTo study if PLA (polylactic acid) -antibiotic coated nails reduces infection and non-union rates and improve the functional outcome in open tibial shaft fracture cases. Materials and methodsIn this prospective cohort study, we included 54 patients with open tibia shaft fractures treated with wound debridement and internal fixation using a reamed PLA (polylactic acid)-antibiotic coated nail (CE-certified, OSSIPRO, MatrixTM). ResultsForty patients with a Grade 2 and ten with grade 3A open tibial fracture, according to the Gustilo-Anderson classification, completed a minimum of six months of follow-up and were included in the analysis. At the final follow-up, four patients (all with grade 3A fracture) had an active infection, 10 (four of grade 2 and six of grade 3A) had non-union, the mean physical component score (SF-36 score) was 55.2 ± 20.10 (grade 2; 58.95 ± 9.99, grade 3A; 40.19 ± 16.37, P value 0.002), and the mean mental component score (SF-36 score) was 54.96 ± 23.5 (grade 2; 57.96 ± 16.63, grade 3A; 42.94 ± 23.75, P value 0.04). Furthermore, Multivariate analysis showed age and grade of fracture to be independently related to the development of infection and non-union. ConclusionAlthough the use PLA-antibiotic coated nail looks promising, short-term results have revealed no additional benefit in terms of reduced infection rates, improved union rates or functional outcomes. Large multicentric randomized controlled trials and a long term follow up are advised to further explore the role of PLA coated antibiotic nails in open tibial fractures.