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.

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.