ArticleJSES reviews, reports, and techniques2025
Randomized controlled trials investigating proximal humerus fractures lack consensus in inclusion criteria.
Article in JSES reviews, reports, and techniques, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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0 citing papers in PubMed.
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.