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

Background: Antibiotic 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. Purpose: To 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 methods: In 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). Results: Forty patients with a Grade 2 and ten with grade 3A open tibial fracture, according to the GustiloAnderson 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 nonunion. Conclusion: Although 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.