Evaluation of the clinical use of the ETN PROtect® in non-union therapy. (August 2019)

• Record Type: Journal Article
• Authors: Moghaddam, Arash; Weis, Johanna; Haubruck, Patrick; Raven, Tim Friedrich; Addali, Ayoub; Schmidmaier, Gerhard
• Is Part Of: Injury. Volume 50(2019)Supplement 3
• Page Start: 32
• Page End: 39
• Publication Date: 2019-08
• Subjects: Non-union -- Intramedullary nailing -- Antibiotic coating -- Tibia -- Gentamicin -- Infection; Wounds and injuries -- Surgery -- Periodicals; Accidents -- Periodicals; Wounds and Injuries -- surgery -- Periodicals; Lésions et blessures -- Chirurgie -- Périodiques; Electronic journals; Electronic journals; 617.1
• DOI: 10.1016/j.injury.2019.07.009
• Languages: English
• ISSNs: 0020-1383

Abstract

Abstract: 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®) 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® 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® 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.