Uncoated vs. Antibiotic-Coated Tibia Nail in Open Diaphyseal Tibial Fracture (42 according to AO Classification): A Single Center Experience

Abstract

Implant-associated infections remain one of the main problems in the treatment of open tibia fractures. The role of systemic antibiotic prophylaxis is now agreed and accepted; nevertheless, recent literature also seems to emphasize the importance of local antibiotic therapy at the fracture site. Several therapeutic strategies have been proposed to overcome this new need. Antibiotic-coated nails play crucial role in this, allowing both infection prevention and favoring the fracture stabilization. We describe the outcome of patients with open diaphyseal tibia fracture treated either with a standard uncoated nail or a gentamicin-coated nail from January 2016 to December 2018 at our second level emergency-urgency department. Primary outcomes were infection rate and bone union rate. Other outcomes reported are reoperation rate, time between injury and nailing, and safety of antibiotic nail. Numerical variables were tabulated using mean, standard deviation, minimum, maximum, and number of observations. Categorical variables were tabulated using number of observations. 23 patients treated with uncoated nail and 23 patients treated with antibiotic-coated tibia nail were included in the study and were evaluated for a minimum follow-up of 18 months. Among the 46 patients, 9 were Gustilo-Anderson type I, 21 type II, and 16 type III open fracture. Regarding the bone healing rate at 12 months, 16 fractures in the first group and 18 in the second were completely healed. 4 infections were found in the first group (3 superficial surgical site infection and 1 osteomyelitis) and 3 superficial infections in the second one. No adverse events have been recorded with antibiotic-coated nails. In this unicentric retrospective study observed no deep wound infections and good fracture healing in the use of antibiotic-coated nails. Antibiotic nails have been shown to play a role in the treatment of fractures in critically ill patients with severe soft tissue damage.

Antibiotic-Coated Nail in Open Tibial Fracture: A Retrospective Case Series

“…Based on our other case studies [9] and on the recent study by Franz et al [21], it seems that gentamicin-coated nails at a higher cost on the market can reduce hospitalization and the rate of re-operation especially in higher risk open fractures (GAIII).…”

“…In another series, outcomes obtained with treatment with uncoated tibia nail and antibiotic-coated nail were compared: 3 patients in antibiotic-coated nail group had presented superficial surgical site infection and required a second intervention for wound debridement and subsequent targeted antibiotic therapy, 6 reoperation (3 dynamizations and 3 superficial wound debridement); regarding the bone healing rate at 12 months, 18 of 23 fractures were completely healed [9].…”

“…Due to specific anatomical features, such as poor soft tissue coverage, poor vascularization, high-energy traumatic mechanism, bone comminution with frequent open fractures, infections are common in tibial fractures [8]. In this bone segment, open fractures showed the highest infection rate (8.8%) compared to closed fractures, where the rate reaches 2% [9].…”

“…Currently, the prevention and treatment of implant-associated infections in open fractures involves the use of high doses of systemic antibiotics which, while reducing the absolute risk of early wound infections by 60% [11], on the other can cause many systemic side effects. Systemic antibiotics can often be ineffective for two main reasons [9,12]: (a) bacteria can colonize the implant surface forming biofilm (glycocalyx) that protects them from the action of systemic antibiotic (b) vascular damage does not allow systemic antibiotics to reach high local concentrations.…”

“…In recent years, new strategies have been developed for prophylactic local administration of antibiotics, e.g., polymethylmethacrylate (PMMA) bone cement [13], PMMA beads [2,14], antibiotic-impregnated collagen sponges [2], polyglycolic acid or poly-DLlactide (PDLLA)-coated implants [9,15,16] and bone allografts impregnated with antibiotics (especially useful for filling large bone defects) [17][18][19]. These implants have the advantage of ensuring, at the same time, a rapid release of antibiotics locally with high concentration at the fracture site and a lower systemic concentration of antibiotics, reducing systemic toxicity and side effects, and from the other side allow the internal fixation of the fracture [12].…”