Updated Meta-Analysis of Randomized Controlled Trials Comparing External Fixation to Intramedullary Nailing in the Treatment of Open Tibial Fractures

Abstract

Background: The purpose of this study was to collect all available randomized controlled trials (RCT) on the treatment of open tibial fractures with an external fixator (EF) and intramedullary nailing (IMN) for meta-analysis to provide reliable evidence-based data for clinical decision-making. Material and methods: The systematic review was undertaken in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and AMSTAR (Assessing the Methodological Quality of Systematic Review). An electronic search of PubMed, Cochrane Library, and Web of Science was performed until 1 March 2023 to identify RCTs which compared either IMN or EF to fix the open tibial fracture. Outcome measures were: postoperative superficial and deep infection, time to union, delayed union, malunion, nonunion and hardware failure. In addition, pain and health-related quality of life were evaluated after 3 and 12 months of follow-up. Results: Sixteen publications comprising 1011 patients were included in the meta-analysis. The pooled results suggested that the IMN technique had a lower postoperative superficial infection and malunion rate (RR = 3.56, 95%CI = 2.56–4.95 and RR = 1.96, 95%CI = 1.12–3.44, respectively), but higher hardware failure occurrence in contrast to EF (RR = 0.30; 95%CI = 0.13–0.69). No significant differences were found in the union time, delayed union or nonunion rate, and postoperative deep infection rate between the treatments. Lower levels of pain were found in the EF group (RR = 0.05, 95%CI = 0.02–0.17, p < 0.001). A difference in quality of life favoring IMN after 3 months was found (RR = −0.04, 95%CI = −0.05–0.03, p < 0.001), however, no statistical difference was found after 12 months (RR = 0.03, 95%CI = −0.05–0.11, p = 0.44). Conclusions: Meta-analysis presented reduced incidence rates of superficial infection, malunion, and health-related quality of life 3 months after treatment in IMN. However, EF led to a significant reduction in pain and incidence rate of hardware failure. Postoperative deep infection, delayed union, nonunion and health-related quality of life 12 months following therapy were similar between groups. More high-quality RCTs should be conducted to provide reliable evidence-based data for clinical decision-making.

Comparative Analysis of Complication Rates in Tibial Shaft Fractures: Intramedullary Nail vs. Ilizarov External Fixation Method

“…A recent updated meta-analysis pooling 16 randomized controlled trials found that IMN resulted in a lower rate of postoperative superficial infection and malunion rate but a higher hardware failure occurrence than EF. Additionally, the meta-analysis found no difference in union time, delayed union or nonunion rate, and postoperative deep infection rate between treatments [21]. Our study's findings agree with this meta-analysis regarding complication rate comparisons.…”

“…We continue to have low and uncertain data on functional outcomes and reoperations [16,19,21,25,30]. Our study observed that the IMN procedure predicted lower pain scores at the fracture site.…”

“…Our study observed that the IMN procedure predicted lower pain scores at the fracture site. The recent updated meta-analysis found that the composite pain score (from four RCTs) favored EF instead [10,21,28,29,31]. This apparent contrast appears to be only due to anterior knee pain, which had unexpectedly high rates after IMN procedures among patients in a subset of studies [23,29].…”

“…Another study observed that after one and a half years, there were no differences in knee motion, ankle motion, fracture site pain, or ankle pain [29]. It is still the case that functional outcomes, such as joint mobility, weight-bearing, rate of chronic pain, patient satisfaction, and quality of life, should be studied more rigorously [21].…”