Comparative study of the efficacy of gentamicin-coated intramedullary interlocking nail versus regular intramedullary interlocking nail in Gustilo type I and II open tibia fractures

Abstract

PurposeOpen tibia fracture is prone to infection, consequently causing significant morbidity and increasing the hospital stay, occupational loss and onset of chronic osteomyelitis. Intramedullary nailing is one choice for treating tibia shaft fractures. To improve the delivery of antibiotics at the tissue-implant interface, many methods have been proposed as a part of prophylaxis against infection. This study was conducted to study the role of gentamicin-impregnated intramedullary interlocking (IMIL) nail in the prevention of infection in Gustilo type I and II open tibia fractures and to compare the results with regular intramedullary nail.MethodsThe study included 28 patients with open tibia fractures (Gustilo type 1 or type 2); of them 14 underwent regular IMIL nailing and the other 14 were treated with gentamicin-coated nailing. Randomization was done by alternate allocation of the patients. Follow-up was done postoperatively (day 1), 1 week, 6 weeks, and 6 months for bone union, erythrocyte sedimentation rate (ESR), hemoglobin and C-reactive protein (CRP). Statistical significance was tested using unpaired t-test. A p value less than 0.05 was considered significant.ResultsThere were 4 cases of infection in controls (regular IMIL nail) and no infection among patients treated with gentamicin-coated nail during the follow up (X2 = 4.66, p = 0.031). At 6 months postoperatively, CRP (p = 0.031), ESR (p = 0.046) and hemoglobin level (p = 0.016) showed significant difference between two groups. The bone healing rate was better with gentamicin-coated nail in comparison to regular IMIL nail at 6 months follow-up (p = 0.016).ConclusionGentamicin-coated IMIL nail has a positive role in preventing infection in Gustilo type I and II open tibia fractures.

Gentamicin-Coated Tibia Nail in Fractures and Nonunion to Reduce Fracture-Related Infections: A Systematic Review

“…The literature search, excluding duplicates, resulted in 32 records ( Figure 1 ). After a full text review, eight studies were included for final analysis ( Table 1 ) [ 16 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ]. According to Oxford’s Level of Evidence, there was one study at level II, one study at level III, and six studies at level IV.…”

“…Among them, two case reports were retrieved and included in the review [ 18 , 19 ]. No studies reported a control population treated with a nail without gentamicin coating, except for Pinto et al, which performed a prospective study with randomization by alternate allocation of the patients [ 24 ]. Out of these studies, 203 patients were retrieved; the median age was 45 ± 13 years.…”

“…One hundred and fourteen patients had a recent fracture treated with coated nail, reported in six studies [ 16 , 18 , 19 , 20 , 21 , 24 ]. Among them were 42 closed fractures (36.84%).…”

“…However, going further into detail, the incidence of FRI in open fractures seems to lower if a coated nail is used. In fact, Pinto et al showed a statistically significant difference ( p = 0.031) in their randomized study in which FRI was higher in the control group [ 24 ]. This is the only trial in the literature that compares coated and non-coated tibia nails.…”

“…In fact, some studies performed a clinical and radiographic follow-up to assess FRI or relapses of previous infections [ 20 , 22 , 23 ]. Some papers have assessed this endpoint by monitoring C reactive protein, erythrocyte sedimentation rate, hemoglobin, and leukocyte count [ 16 , 18 , 19 , 21 , 24 ]. In suspicious cases, further analyses were performed to confirm FRI.…”