Abstract
Objectives:
The treatment of displaced clavicle shaft fractures has evolved due to complications experienced by conservatively treated patients. Numerous operative modalities are available with various positive and negative aspects associated with each technique. This prospective randomized controlled trial compares the outcome of patients treated operatively with a novel locked intramedullary device and patients treated by traditional anatomically contoured locked plating.
Methods:
Patients with displaced and shortened clavicle shaft fractures were randomized according to presentation into 2 groups - intramedullary fixation and anatomically contoured locked plating. All patients were operated by the same surgeon with similar post-operative regimes for both groups. Outcomes accessed were DASH and Constant Shoulder scores at 6 weeks, 3 months and 6 months, scar size and quality, operative time, union rate and incidence of supraclavicular nerve injury at the time of surgery. Patients were assessed by the operative surgeon, a physiotherapist and an occupational therapist. Progression to union was assessed by a radiologist.
Results:
40 patients with 6 months follow-up were available for review - 20 in each group. No statistically significant difference in average DASH and Constant Shoulder scores at 6 weeks, 3 months and 6 months for the two groups were found. The surgical scars were smaller and the cosmetic result better in the intramedullary group. Operative time was significantly shorter in the intramedullary group. Both groups achieved a 100% union rate at 6 months post-op. The rate of supraclavicular nerve injury in the plating group was higher and most patients complained of prominent hardware.
Conclusion:
Locked intramedullary fixation of clavicle shaft fractures using the Sonoma CrX system was found to be a reliable method of achieving fracture reduction and fracture union. Shoulder function was restored and union achieved with a good cosmetic result. Supraclavicular nerve injury is rare and a second operation to remove prominent hardware is not necessary. Patient outcomes were found to be similar to that achieved by anatomically contoured locked plating - the current accepted gold standard method of treatment.