No clinical benefits using a new design of pins for external fixation: a randomized study in 50 patients operated on by the hemicallotasis technique

Abstract

Pin-site infection and pin loosening are complications that can cause discomfort to the patients. The purpose of present study was to evaluate pin-site infection, pain, and the use of medications using the XCaliber pin (Orthofix) with optimized thread and tip design, and the commonly used standard pin (Orthofix) during the procedure of hemicallotasis osteotomy (HCO). Fifty patients of mean age 51 (35-66) years treated with HCO were randomized to standard pins (Orthofix) or XCaliber pins (Orthofix). Hydroxyapatite-coated pins were used in the metaphyseal bone and non-coated pins in the diaphyseal bone in both groups. Pin sites, pain, and the use of medications were evaluated weekly during the HCO. At week 7 the patients in the XCaliber group had more pain at rest [19 (22) vs. 5 (5) mm, P = 0.01] and during activity [32 (32) vs. 12 (13) mm, P = 0.02] and used more paracetamol (2,100 vs. 925 mg, P = 0.04) than those in the standard group, with similar differences, until the extraction of the pins. There was no difference in the use of antibiotics [10.5 (14.5) days (XCaliber) vs. 7 (7.5) days (standard) (P = 0.16)]. The commonly used standard pin has important clinical- and patient-related benefits.