Comparison of complications of early and delayed open reduction and internal fixation for treating pilon fracture: A protocol of systematic review and meta-analysis

Background: Tibial Pilon fractures are severe fractures accompanied by soft tissue injury. Although open reduction and internal fixation (ORIF) are effective in treating Pilon fractures, there is a controversy over time to surgery due to reported postoperative complications. However, there is no systematic review evaluating the difference of postoperative complications between early and delayed ORIF for treating pilon fractures. Methods: Relevant literature written in English will be searched through PubMed, Cochrane Library, Embase, MEDLINE, and Web of Science. The study aims to compare the effects and complications of early and delayed ORIF for treating fresh pilon fractures in adult patients. The primary outcome will be infection rate, fracture union time, nonunion and malunion rate. And the secondary outcome will be metalwork removal, amputation, and ankle function grade. Two reviewers will independently assess the eligibility of the studies according to the pre-defined inclusion and exclusion criteria. A meta-analysis for the available data will be conducted using Revman 5.3. To measure effect size, odds ratios (ORs) and mean difference will be used for dichotomous and continuous data, respectively. Statistical heterogeneity will be explored. And a random-effects model or a fixed-effects will be used in pooled data on the basis of the existence or absence of heterogeneity. Subgroup analysis will be conducted to identify sources of heterogeneity and sensitivity analysis to test the results’ robustness. We will assess the risk of bias by four different quality assessment tools according to the study design. Publication bias will be evaluated by funnel plot. The study data will be stored in the Open Science Framework website. PROSPERO registration number: CRD42020207465