Five-Year follow-up results of a rondomized controlled study comparing intramedullary nailing With plate fixation of completely displaced midshaft fractures of the clavicle in adults

Background: Surgical management of completely displaced midshaft fractures of the clavicle is becoming more frequent, although long-term follow-up with Level-I evidence is scarce. Plate fixation (PF) of comminuted fractures provides faster functional recovery than elastic stable intramedullary nailing (ESIN). The 12-month follow-up of this randomized controlled trial, published previously, found no clinical differences at that time on the group level, but subtle differences on the subgroup level indicated that the results after closed ESIN were better than those after open ESIN. The primary aim of the study reported here was to compare the long-term clinical outcomes and sequelae after open reduction with those after closed reduction and to help surgeons develop a treatment strategy of either PF or ESIN for selected patients. Methods: At a median follow-up of 66 months (range, 49 to 89 months), the 123 patients in the original study were invited to an online secure survey. We used the survey results to compare the PF and ESIN treatment arms and to perform predetermined subgroup analyses of closed compared with open ESIN in relation to Disabilities of the Arm, Shoulder and Hand (DASH) score, pain assessment, and implant removal. Results: The questionnaire was completed by 114 (93%) of the 123 patients. There were no differences between the 2 treatment arms with regard to the DASH score (ESIN, 3.1 +/- 7.0 and PF, 3.7 +/- 7.5; p = 0.9). The 27 patients who had been treated with closed ESIN had a significantly superior DASH score compared with the 27 patients who had been treated with open ESIN (closed, 0.7 +/- 1.4 and open, 5.2 +/- 8.9; p = 0.015) and compared with the patients who had been treated with PF (closed ESIN, 0.7 +/- 1.4 and PF, 3.9 +/- 7.5; p = 0.002). Patients who had been treated with closed ESIN also reported fewer sequelae than patients who had been treated with open ESIN or PF. Conclusions: The results of this study, combined with those of our prior 1-year follow-up of the same patients, indicate that it seems to be advantageous to perform closed ESIN. The long-term results after PF were similar to those after open ESIN, but PF resulted in faster functional recovery and fewer patients needing to have the implant removed. Therefore, if open reduction is necessary for a comminuted fracture, it seems that the advantages of the minimally invasive ESIN procedure are lost, and the surgeon should consider conversion to PF. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence