Quality assessment of prospective cohort and randomized controlled trials evaluating surgical treatment of proximal humerus fractures: a systematic review

Purpose: This study offers a systematic review and quantitative evaluation of the methodological quality of prospective studies comparing open reduction and internal fixation (ORIF) and reverse total shoulder arthroplasty (RTSA) for the treatment of proximal humerus fractures. Methods: A systematic review was conducted in accordance with PRISMA guidelines identifying prospective cohort studies or randomized controlled trials (RCTs) comparing ORIF and RTSA for the management of traumatic proximal humerus fractures in skeletally mature patients. Two reviewers independently evaluated the methodologic quality and risk of bias of the included studies. Scarcity and heterogeneity of data precluded any pooled analysis from being performed. Results: The search yielded 1064 unique articles, of which five met inclusion criteria. The Methodological Index for Non-randomized Studies (MINORS) score for the comparative prospective cohort studies ranged from 12 to 19, corresponding to low (1), moderate (1), and high (2) quality studies. The mean modified Coleman Methodology score of the lone RCT was 70.5, corresponding to a categorical rating of “good,” while the mean revised Consolidated Standards of Reporting Trials (CONSORT) score was 19, corresponding to a categorical rating of “excellent.” The RCT had a low risk of bias, while the prospective cohort studies exhibited serious risk of bias. Conclusion: There is a paucity of comparative literature evaluating ORIF and RTSA for the treatment of proximal humerus fractures, which is of variable methodological quality. In the absence of consistent, high-quality evidence, surgeons should consider patient-specific factors and technical experience when considering operative treatment options.