Treatment of severely open tibial fractures, non-unions, and fracture-related infections with a gentamicin-coated tibial nail-clinical outcomes including quality of life analysis and psychological ICD-10-based symptom rating.

Abstract

Implant-associated infections depict a major challenge in orthopedics and trauma surgery putting a high burden on the patients and health care systems, strongly requiring improvement of infection prevention and of clinical outcomes. One strategy includes the usage of antimicrobial-coated implants. We evaluated outcomes after surgical treatment using a gentamicin-coated nail on (i) treatment success in terms of bone consolidation, (ii) absence of infection, and (iii) patient-reported quality of life in a patient cohort with high risk of infection/reinfection and treatment failure. Thirteen patients with open tibia fractures (n = 4), non-unions (n = 2), and fracture-related infection (n = 7) treated with a gentamicin-coated intramedullary nail (ETN Protect^TM) were retrospectively reviewed. Quality of life was evaluated with the EQ-5D, SF-36, and with an ICD-10-based symptom rating (ISR). At a mean follow-up of 2.8 years, 11 of the 13 patients (84.6%) achieved bone consolidation without any additional surgical intervention, whereas two patients required a revision surgery due to infection and removal of the implant. No specific implant-related side effects were noted. Quality of life scores were significantly lower compared to a German age-matched reference population. The mean ISR scores revealed mild psychological symptom burden on the scale depression. The use of a gentamicin-coated intramedullary nail seems to be reasonable in open fractures and revision surgery for aseptic non-union or established fracture-related infection to avoid infection complications and to achieve bony union. Despite successful treatment of challenging cases with the gentamicin-treated implant, significantly reduced quality of life after treatment underlines the need of further efforts to improve surgical treatment strategies and psychological support.