Evaluation of the clinical use of the ETN PROtect® in non-union therapy

Introduction: Non-union of a long bone fracture remains a challenge in orthopaedic and trauma surgery. In the current study, we sought to determine the clinical effectiveness of tibial non-union treatment utilizing an antibiotic-coated intramedullary nail (Expert Tibia Nail (ETN) PROtect (R)) regarding prevention and treatment of infection and the clinical outcome. Patients and methods: 36 patients suffering from tibial non-unions that were treated with the ETN PROtect (R) in the course of non-union treatment between February 2010 and March 2015 were included in this clinical observational study. Clinical and radiological examinations were performed preoperatively as well as 4, 6 and 12 weeks and 6 and 12 months postoperatively as part of a standardized follow-up program. Data regarding perioperative complications, weight-bearing capacity, radiological signs of consolidation and subjective health status were assessed at each time point. Laboratory parameters such as C-reactive protein (CRP) and leukocyte count were collected preoperatively in order to assess the patients' risk profile for infection. Results: Patients had an average of 6.2 previous surgeries and 22 patients (61.1%) had a positive bacterial culture from intraoperatively removed tissue during the first operative treatment. 29 patients (80.6%) achieved full weight-bearing after an average of 7.7 months, furthermore 80.6% of patients achieved osseous consolidation. 3 deep infections occurred, including one amputation. Subjective health status increase based on the SF-12 questionnaire during our follow-up program. Conclusion: The results from the current study indicate that the use of the ETN PROtect (R) in the applied non-union therapy has a high clinical effectiveness regarding osseous consolidation and time to weight bearing. In addition, the use of gentamicin-coated nails in the treatment of tibial non-unions might contribute to both successful treatment of the underlying infection and prevention of perioperative infection. The gentamicin-coated nail may serve as a beneficial adjunct treatment in the applied nonunion therapy in addition to all established techniques in the treatment of infected non-unions. (C) 2019 Published by Elsevier Ltd.