Arash Moghaddam1, Johanna Weis2, Patrick Haubruck2, Tim Friedrich Raven3, Ayoub Addali2, Gerhard Schmidmaier2. 1. ATORG - Aschaffenburg Trauma and Orthopaedic Research Group, Centre for Orthopedics, Trauma Surgery und Sports Medicine, Aschaffenburg-Alzenau, Germany; HTRG - Heidelberg Trauma Research Group, Center for Orthopedics, Trauma and Spinal Cord Injury, Heidelberg University Hospital, Heidelberg, Germany. Electronic address: arashmoghaddam@web.de. 2. HTRG - Heidelberg Trauma Research Group, Center for Orthopedics, Trauma and Spinal Cord Injury, Heidelberg University Hospital, Heidelberg, Germany. 3. ATORG - Aschaffenburg Trauma and Orthopaedic Research Group, Centre for Orthopedics, Trauma Surgery und Sports Medicine, Aschaffenburg-Alzenau, Germany; HTRG - Heidelberg Trauma Research Group, Center for Orthopedics, Trauma and Spinal Cord Injury, Heidelberg University Hospital, Heidelberg, Germany.
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.
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.