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Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark
Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
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Establishment of orthopaedic registers started in 1975 and many registers have been initiated since. The main purpose of registers is to collect information on patients, implants and procedures in order to monitor and improve the outcome of the specific procedure.
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Data validity reflects the quality of the registered data and consists of four major aspects: coverage of the register, registration completeness of procedures/patients, registration completeness of variables included in the register and accuracy of registered variables.
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Survival analysis is often used in register studies to estimate the incidence of an outcome. The most commonly used survival analysis is the Kaplan–Meier survival curves, which present the proportion of patients who have not experienced the defined event (e.g. death or revision of a prosthesis) in relation to the time. Depending on the research question, competing events can be taken into account by using the cumulative incidence function. Cox regression analysis is used to compare survival data for different groups taking differences between groups into account.
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When interpreting the results from observational register-based studies a number of factors including selection bias, information bias, chance and confounding have to be taken into account. In observational register-based studies selection bias is related to, for example, absence of complete follow-up of the patients, whereas information bias is related to, for example, misclassification of exposure (e.g. risk factor of interest) or/and outcome.
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The REporting of studies Conducted using Observational Routinely-collected Data guidelines should be used for studies based on routinely-collected health data including orthopaedic registers.
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Linkage between orthopaedic registers, other clinical quality databases and administrative health registers may be of value when performing orthopaedic register-based research.
Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180097
Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
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Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark
Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
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Background
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There are several studies on nonunion, but there are no systematic overviews of the current evidence of risk factors for nonunion. The aim of this study was to systematically review risk factors for nonunion following surgically managed, traumatic, diaphyseal fractures.
Methods
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Medline, Embase, Scopus, and Cochrane were searched using a search string developed with aid from a scientific librarian. The studies were screened independently by two authors using Covidence. We solely included studies with at least ten nonunions. Eligible study data were extracted, and the studies were critically appraised. We performed random-effects meta-analyses for those risk factors included in five or more studies. PROSPERO registration number: CRD42021235213.
Results
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Of 11,738 records screened, 30 were eligible, and these included 38,465 patients. Twenty-five studies were eligible for meta-analyses. Nonunion was associated with smoking (odds ratio (OR): 1.7, 95% CI: 1.2–2.4), open fractures (OR: 2.6, 95% CI: 1.8–3.9), diabetes (OR: 1.6, 95% CI: 1.3–2.0), infection (OR: 7.0, 95% CI: 3.2–15.0), obesity (OR: 1.5, 95% CI: 1.1–1.9), increasing Gustilo classification (OR: 2.2, 95% CI: 1.4–3.7), and AO classification (OR: 2.4, 95% CI: 1.5–3.7). The studies were generally assessed to be of poor quality, mainly because of the possible risk of bias due to confounding, unclear outcome measurements, and missing data.
Conclusion
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Establishing compelling evidence is challenging because the current studies are observational and at risk of bias. We conclude that several risk factors are associated with nonunion following surgically managed, traumatic, diaphyseal fractures and should be included as confounders in future studies.
