The use of a gentamicin-coated titanium nail, combined with RIA system, in the management of non-unions of open tibial fractures: A single centre prospective study

Abstract

Background: Nonunion is a quite common complication of open tibial shaft fractures. This prospective case series investigates the use of the gentamicin-coated titanium intramedullary tibial nail, in association with the RIA system, in patients with tibial exposed nonunions.

Methods: Between January 2015 and January 2018, patients meeting the inclusion and exclusion criteria were recruited.

Inclusion criteria: patients aged 18 or more; non-union after an open tibial shaft fracture; previous treatment with a circular external fixator.

Exclusion criteria: a known allergy to aminoglycosides; pin tract infections; persistent soft-tissues damage; patients pregnant, breastfeeding or planning to become pregnant during the study; history of malignant disease; a life expectancy of fewer than three months; medical illness or cognitive disorders precluding participation in the follow-up examination. All the patients underwent a clinical and radiological follow-up at one-, three-, six- and twelve-months post-operatively. Clinical evaluation was performed using the following validated scores: Euro-Quality 5 D (EQ-5D); American Orthopedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale and the Visual Analogue Scale (VAS) for pain.

Results: Seventeen patients met the inclusion and exclusion criteria (male: 11; female: 6; mean age: 41.12 ± 11.4). Fracture healing was observed in all the patients; the mean time needed to obtain the fracture healing was 7.18 months. A significant improvement of the quality of life, evaluated with the EQ-5D, and of the mean VAS for pain was observed from the three-months follow-up. The mean AOFAS score showed a significant increase at six-months follow-up.

Conclusions: The use of gentamicin-coated nails in association with the RIA system demonstrated a safe and effective treatment of tibial non-unions.

Keywords: Antibiotic coating; Antibiotic-coated nail; Bone infection; Circular external fixation; Coating; Delayed-union; Gentamicin; Intramedullary nail; Intramedullary nailing; Open fractures; Open tibial non-union; Osteomyelitis; RIA system; Reaming Irrigation Aspiration; Tibia.