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

Abstract

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®) regarding prevention and treatment of infection and the clinical outcome. 36 patients suffering from tibial non-unions that were treated with the ETN PROtect® 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. 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. The results from the current study indicate that the use of the ETN PROtect® 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 non-union therapy in addition to all established techniques in the treatment of infected non-unions.