Proximal humeral internal locking plate combined with a custom neutral-position shoulder and elbow sling for proximal humerus fractures: A randomized study

OBJECTIVES: The aim of this study was to investigate the effectiveness of the proximal humeral internal locking system (PHILOS) plate combined with a custom neutral-position shoulder and elbow sling for proximal humerus fractures. METHODS: A total of 112 patients with proximal humerus fractures were assigned randomly into 2 groups. Group A (n = 56) was treated by open reduction and internal fixation (ORIF) with a PHILOS plate; group B (n = 56) was treated by ORIF with a PHILOS plate in combination with the use of a custom neutral-position shoulder and elbow sling for 30 days after surgery. The incidence of internal fixation failure, the Constant–Murley shoulder assessment, and Visual Analogue Scale (VAS) score were recorded and analyzed. RESULTS: Patients included were followed up for an average of 15 months (range, 6–24 months). No significant differences were observed in mean VAS scores and mean Constant–Murley shoulder assessment scores at 1-day preoperative and postoperative day 3 between groups A and B. However, mean VAS scores and mean Constant–Murley shoulder assessment in group B were significantly improved when compared with group A at postoperative day 30 and the final follow-up. No cases of postoperative infection, loss of reduction, PHILOS break, or vascular nerve injury occurred in either group. CONCLUSIONS: Proximal humerus fractures treated with the combination of the PHILOS and custom neutral-position shoulder and elbow sling for 30 days after operation was associated with a lower incidence of internal fixation failure. There was no increase in adverse events compared with open reduction and internal fixation with a PHILOS plate alone.