Randomized controlled trials investigating proximal humerus fractures lack consensus in inclusion criteria

This study aimed to investigate inclusion and exclusion criteria for subjects of randomized control trials (RCTs) studying operative management of proximal humerus fractures (PHFs) and to define the presence or absence of objectivity and consensus among these inclusion and exclusion criteria of these studies.

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, PubMed, Web of Science, and Scopus were queried from inception to September 1, 2023, for RCTs studying PHFs. Studies were included if they investigated operative management of PHFs, had defined inclusion and exclusion criteria, were published in the English language, and were in peer-reviewed journals. RCTs were excluded if they were investigating only nonoperative management of PHFs. The inclusion and exclusion criteria were extracted from these studies and compared using descriptive statistics following study screening.

A total of 42 RCTs met the inclusion criteria, of which 9 investigated surgical vs. conservative management and 33 compared surgical techniques. The Neer fracture classification system was utilized most frequently in 30 (71.4%) studies in fracture pattern description. Only 8 studies defined the direction of angulation and 3 defined the ratio of displacement of the shaft with relation to the head. Injury chronicity and mechanism were rarely included (21.4% and 19.0%, respectively). Most (73.9%) included age within their inclusion and exclusion criteria. Other patient-specific factors including sex and baseline function/independence were scarce.

In RCTs studying PHFs, most studies rely on fracture pattern classification systems to describe inclusion and exclusion criteria, but these fail to objectively delineate which fractures should be included. Few studies include additional elements to improve objectivity of fracture pattern characterization. Besides age, most RCTs on surgical management of PHFs do not include patient-specific variables within their inclusion and exclusion criteria.