Background: The use of antibiotic-coated implants may reduce the rate of infection and facilitate fracture healing after surgical treatment of tibial shaft fractures. A new biodegradable gentamicin-loaded coating of an implant (UTN PROtect) was CE-certified in August 2005. In this prospective, non-randomized case series, we investigated the clinical, laboratory and radiological outcomes of 21 patients who underwent surgical treatment in closed or open tibial fractures, as well as revisions with the UTN PROtect gentamicin-coated intramedullary nail.
Methods: Of 21 patients (13 men, 8 women), 19 completed the 6-month follow-up. The study population included patients with complex tibial fractures and late revision cases. Clinical outcomes comprised adverse events, including infections and the SF-36 physical score. Laboratory outcomes, including C-reactive protein and leukocyte count as inflammatory markers, haemoglobin and serum gentamicin, were measured at baseline and up to 6 months post operatively. Radiographic assessments of fracture healing and weight-bearing capacity were determined at 5 weeks, 3 and 6 months after surgery.
Results: No implant-related infections occurred; one patient had superficial wound healing problems. Mean C-reactive protein levels remained below 5 mg/L throughout the study, with a peak at 4-7 days after surgery (4.4 mg/L; range 0.5-16.1 mg/L). Leukocyte counts and haemoglobin levels did not vary over time during the study. The mean SF-36 physical score at 6 months was 42.6 (range 19.4-56.7). Radiographic union defined as three or four bridged cortices was achieved in 11 patients (58%) after 6 months. The remaining eight patients showed partial fracture healing with one or two bridged cortices. Additionally, 13 patients (68%) demonstrated full weight-bearing capacity after 6 months.
Conclusions: The use of the UTN PROtect intramedullary nail was associated with good clinical, laboratory and radiological outcomes after 6 months. These preliminary results support the use of gentamicin-coated implants as a new potential treatment option for the prevention of infection in trauma patients and in revision cases.
Level of evidence: Level II.