Network Meta-Analyses: Unreamed nailing best treatment for open tibial shaft fractures

Study Type: Therapy
OE Level of Evidence: 1
Journal Level of Evidence: 1
Dr. C.J. Foote discusses a network meta-analysis assessing treatments for open tibial shaft fractures.
A comprehensive review and network meta-analysis was conducted looking at the complication rates requiring reoperation for all stabilization techniques for open tibial shaft fractures (Gustilo Types I – IIIB). Treatments evaluated were plate fixation, external fixation (by any method), reamed and unreamed intramedullary nailing, and Ender intramedullary nailing. Fourteen trials including Please login to view the rest of this report. Please login to view the rest of this report.
Funding: 0
Why was this study needed now?
Open tibial shaft fractures are complex injuries and associated with devastating complications, including deep infection, wound dehiscence, and hardware failure requiring subsequent unplanned reoperation(s). Through large cohort studies, it is now recognized that these fractures contribute heavily to the growing burden of musculoskeletal trauma worldwide. The largest trial (SPRINT) of tibial shaft fractures demonstrated a nonsignificant trend toward a reduced reoperation rate with unreamed nailing over reamed nailing, but was underpowered to specifically evaluate complications in open fractures. Since the publication of SPRINT, there have been a resurgence of smaller trials evaluating treatments for open fractures, looking at many stabilization techniques that have been inconclusive, mainly due to small sample size. The optimal treatment for these fractures therefore remains unknown. Network meta-analyses are a powerful tool that generate estimates of effect by using direct and indirect (through common comparators) evidence. The improved power may improve the precision of our estimates of effect, thus allowing for more robust comparisons between treatments. A network analyses also allows for the evaluation of the most probable ‘best’ treatment that is useful for surgeons. Lastly, the evaluation of co-interventions in open fractures is of great interest in orthopaedic traumatology; such a comprehensive review could identify areas of practice variation that require further study.
What was the principal research question?
What surgical stabilization technique for Gustilo type I to IIIb fractures is associated with the lowest rate of complications?
Data Source: Cochrane Central Registry for Randomized Controlled Trials (February 2013, Issue 1), EMBASE (1980–2013), and OVID MEDLINE In-Process & Other Non-Indexed Citations (1981–2013), and OVID MEDLINE (1981–2013). In EMBASE and MEDLINE, subject-specific search strategies with The Scottish Intercollegiate Guidelines Network (SIGN) filter for randomized controlled trials was used. Manual search through appropriate journals and conferences were performed. A search for ongoing trials was performed.
Index Terms: Conducted by a registered librarian and included 146 lines of code. Included terms such as 'tibia', 'shin', 'plate', 'nail', 'fixation', 'external', 'trials' (multiple variants of trial such as 'single-blind', 'double-blind' 'quasirandomized' 'randomized'), and all acronyms of fixation including 'ORIF' 'IF' 'IMN' 'exfix' 'AO' etc)
Study Selection: 14 randomized trials were included from 2 independent adjudicators based on the following criteria: published and unpublished, randomized or quasirandomized, adult patients with open fractures of the tibial diaphysis, 80% of the patients were 18 years or older at the time of enrollment, the study compared any two of the following stabilization techniques: plate fixation, external fixation (by any method), reamed and unreamed intramedullary nailing, Ender intramedullary nailing, or conservative treatment (cast, brace, splint); all important unplanned reoperations must have been reported for inclusion.
Data Extraction: Two reviewers extracted important patient and injury characteristics, including patient age, sex, smoking status, comorbidities, American Society of Anesthesiologists grade, location of the fracture in the tibial shaft, Gustilo grade, and description of the fracture orientation (eg, transverse, oblique). The timing of surgery, type of antibiotic used, type of irrigation solution, and irrigation pressure, timing, and type of wound closure and coverage, and adjunctive treatment, such as antibiotic bead pouch use or delayed bone grafting. Outcomes including unplanned reoperation, infection (deep and superficial), malalignment, malunion. Study characteristics such as whether the trial was registered, years of recruitment and publication, location and number of study centers, trial type (quasirandomized; parallel, randomized), and length and completeness of follow up. The quality of the conduct and reporting of the trials (risk of bias) was evaluated by the Cochrane Handbook for Systemic Reviews of Interventions 5.1.0 risk of bias tool. This was independently by 3 authors.
Data Synthesis: A random-effects model to pool effect estimates from included trials and report odds ratios (OR) with 95% CI for direct comparisons using. RevMan Version 5 (The Cochrane Collaboration, 2014; The Nordic Cochrane Centre, Copenhagen, Denmark). This was done for the primary outcome of reoperation, malunion, deep infection, superficial infection, and all infection. For direct estimates, heterogeneity of trials was assessed using the I2 statistic from the Cochran Q statistic. For the network meta-analyses evaluating unplanned clinically-important reoperations, a fixed-effects multiple treatment comparison meta-analysis using a Bayesian Markov chain Monte Carlo method and reported ORs with 95% CIs. A node-splitting procedure was used to generate separate estimates from direct and indirect evidence for all 15 possible comparisons. In addition to indirect estimates being generated, another estimate called the ‘network’ estimate was generated by the model (most robust) that uses data from both direct and indirect evidence. Differences between direct and indirect estimates of effect were statistically evaluated. If there was a significant discrepancy between estimates, the direct estimate was considered best evidence. On the contrary, if there was no significant discrepancy between evidence types, the network estimate was considered best evidence. The probability of each treatment having the lowest reoperation rate, second lowest, third lowest, and so on was calculated. The Surface Under the Cumulative RAnking curve (SUCRA) method was used to assess the cumulative probability of each stabilization strategy being superior compared with alternatives.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.