Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions

Abstract

Background: The most frequently used surgical procedures for treating a proximal humeral fracture (PHF) are plate osteosynthesis, nail osteosynthesis and arthroplasty. Evidence-based recommendations for an appropriate surgical procedure after PHF requires transparent and valid safety data. We performed a systematic review to examine reported terms and definitions of complications after surgically-treated PHFs. Methods: A literature search was conducted on PubMed, Cochrane Library, EMBASE, Scopus and WorldCat to identify clinical articles and book chapters on complications of PHF published from 2010 to 2017. Complication terms and definitions were extracted from each selected article independently by two reviewers and grouped according to a predefined scheme. Results: From 1376 initial references, we selected 470 articles, of which 103 were reviewed in reverse chronological order until no further information was gained. Twelve book chapters were reviewed. We found 667 local event terms associated with complications after surgical treatment of PHFs. The most frequently used event terms were infection (52 references), nonunion (n = 42), malunion (n = 35), avascular necrosis (n = 27) and pain (n = 25). Overall, 345, 177, 257 and 102 local event terms were related to plating, nailing, arthroplasty and other surgical techniques, respectively. Radiological assessment was the basis for the majority of event terms and complication definitions. Thirty-six event definitions were extracted, mostly defining the terms "secondary fracture displacement", "screw perforation/cutout", "malunion", "delayed healing" and "notching". Conclusion: Scientific literature on surgically-managed PHF uses different terms to describe complications and without approved definitions, which highlights a lack of agreement on adverse event terminology for PHFs. Defined event terms are mostly based on radiological observations. Consensus among shoulder surgeons on a core event set is indispensable to support the standardization of safety reporting for surgically-treated PHFs.

Functional results and unfavorable events after treatment of proximal humerus fractures using a new locking plate system

“…In a systematic review, Alispahic et al summarized and sorted all the unfavorable events which were found in studies of proximal humerus fractures. In our study, the unfavorable events are presented in detail and in a differentiated manner, as Alispahic et al have published [ 2 ]. A total of 48 unfavorable events were seen in 27 (27.6%) patients in our study.…”

“…Based on a recently published literature research by Alispahic et al the term “unfavorable events” (synonym: complication, adverse events) was used in our study [ 2 ]. The unfavorable events were divided into several groups as shown in Table 2 .…”

Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process

“…While many terms are used in the literature to describe similar or associated events or conditions [ 6 , 7 ], some choices and decisions were made on what was perceived the most relevant terms that could be understood by the majority of clinicians (however not necessarily all stakeholders like the patients themselves). Some terms were conscientiously avoided.…”

“…We applied a similar methodological process for the development of the PHF CES as that used for ARCR [ 10 ] and SA [ 11 ]. Unfavorable event terms and definitions were identified from a systematic literature review including original articles published between 2010 and 2017, and grouped according to nine previously defined event groups [ 6 , 7 ]. An initial proposal for the PHF CES was drafted during a meeting of the authors, all members of the steering committee for this project.…”

“…Validated clinical outcome instruments are available and widely used for reporting treatment effects [ 4 , 5 ]. However, when it comes to reporting of complications and adverse events (AEs) after management of PHF there is a paucity of standardized and validated terms and definitions [ 6 , 7 ]. Adverse events were included by international consensus in a preliminary Core Outcome Set (COS) for shoulder disorders [ 8 ], further highlighting the need for more standardization [ 9 ].…”