Comparison of novel intramedullary nailing with mini-invasive plating in surgical fixation of displaced midshaft clavicle fractures

Abstract

Introduction: This prospective randomized pilot study sought to determine whether fixation with Sonoma CRx intramedullary pin is a comparable alternative to minimally invasive plating fixation in patients with displaced clavicle fractures. Materials and methods: A total of 45 consecutive patients (Robinson class B1 or B2) were randomly allocated into two groups; intramedullary pin (IMP) group (n = 24, mean age; 33.17 ± 8.60 years, 14 males 58.3 %) received Sonoma CRx Collarbone pin (Sonoma, USA) whereas locking midshaft superior plating (MIPPO) group (n = 21, 32.38 ± 8.41 years, 12 males) patients received minimally invasive locking midshaft superior plating (Acumed, USA). Patients were followed up with a mean time of 11.82 ± 4.22 and 14.45 ± 6.43 months, respectively. Functional status, as the primary outcome measure, was assessed using quick disability of the arm, shoulder and hand (DASH) scores. Results: Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group (p < 0.001 and p = 0.03, respectively). Time of hospital stay was significantly shorter in IMP group (p < 0.001). Complications were rare in the early postoperative period. Time until bony union was significantly shorter in IMP group. Mean quick DASH scores were not significantly different between two groups. Implant failure occurred in one patient from each group. Cosmetic dissatisfaction was more common in MIPPO group. Conclusion: Given the shorter operative times and better cosmetic appearance, Sonoma CRx intramedullary pin may be an alternative to minimally invasive plating. Further safety studies are warranted.