Dataset Information

Which Surgical Treatment for Open Tibial Shaft Fractures Results in the Fewest Reoperations? A Network Meta-analysis.

ABSTRACT:

Background

Open tibial shaft fractures are one of the most devastating orthopaedic injuries. Surgical treatment options include reamed or unreamed nailing, plating, Ender nails, Ilizarov fixation, and external fixation. Using a network meta-analysis allows comparison and facilitates pooling of a diverse population of randomized trials across these approaches in ways that a traditional meta-analysis does not.

Questions/purposes

Our aim was to perform a network meta-analysis using evidence from randomized trials on the relative effect of alternative approaches on the risk of unplanned reoperation after open fractures of the tibial diaphysis. Our secondary study endpoints included malunion, deep infection, and superficial infection.

Methods

A network meta-analysis allows for simultaneous consideration of the relative effectiveness of multiple treatment alternatives. To do this on the subject of surgical treatments for open tibial fractures, we began with systematic searches of databases (including EMBASE and MEDLINE) and performed hand searches of orthopaedic journals, bibliographies, abstracts from orthopaedic conferences, and orthopaedic textbooks, for all relevant material published between 1980 and 2013. Two authors independently screened abstracts and manuscripts and extracted the data, three evaluated the risk of bias in individual studies, and two applied Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria to bodies of evidence. We included all randomized and quasirandomized trials comparing two (or more) surgical treatment options for open tibial shaft fractures in predominantly (ie, > 80%) adult patients. We calculated pooled estimates for all direct comparisons and conducted a network meta-analysis combining direct and indirect evidence for all 15 comparisons between six stabilization strategies. Fourteen trials published between 1989 and November 2011 met our inclusion criteria; the trials comprised a total of 1279 patients surgically treated for open tibial shaft fractures.

Results

Moderate confidence evidence showed that unreamed nailing may reduce the likelihood of reoperation compared with external fixation (network odds ratio [OR], 0.38; 95% CI, 0.23-0.62; p < 0.05), although not necessarily compared with reamed nailing (direct OR, 0.74; 95% CI, 0.45-1.24; p = 0.25). Only low- or very low-quality evidence informed the primary outcome for other treatment comparisons, such as those involving internal plate fixation, Ilizarov external fixation, and Ender nailing. Method ranking based on reoperation data showed that unreamed nailing had the highest probability of being the best treatment, followed by reamed nailing, external fixation, and plate fixation. CIs around pooled estimates of malunion and infection risk were very wide, and therefore no conclusive results could be made based on these data.

Conclusion

Current evidence suggests that intramedullary nailing may be superior to other fixation strategies for open tibial shaft fractures. Use of unreamed nails over reamed nails also may be advantageous in the setting of open fractures, but this remains to be confirmed. Unfortunately, these conclusions are based on trials that have had high risk of bias and poor precision. Larger and higher-quality head-to-head randomized controlled trials are required to confirm these conclusions and better inform clinical decision-making.

Level of evidence

Level I, therapeutic study.

SUBMITTER: Foote CJ

PROVIDER: S-EPMC4457757 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Publications

Which Surgical Treatment for Open Tibial Shaft Fractures Results in the Fewest Reoperations? A Network Meta-analysis.

Foote Clary J CJ Guyatt Gordon H GH Vignesh K Nithin KN Mundi Raman R Chaudhry Harman H Heels-Ansdell Diane D Thabane Lehana L Tornetta Paul P Bhandari Mohit M

Clinical orthopaedics and related research 20150228 7

<h4>Background</h4>Open tibial shaft fractures are one of the most devastating orthopaedic injuries. Surgical treatment options include reamed or unreamed nailing, plating, Ender nails, Ilizarov fixation, and external fixation. Using a network meta-analysis allows comparison and facilitates pooling of a diverse population of randomized trials across these approaches in ways that a traditional meta-analysis does not.<h4>Questions/purposes</h4>Our aim was to perform a network meta-analysis using e ...[more]

PMID: 25724836

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Project description:ContextAcute tibial shaft fractures represent one of the most severe injuries in sports. Return rates and return-to-sport times after these injuries are limited, particularly with regard to the outcomes of different treatment methods.ObjectiveTo determine the current evidence for the treatment of and return to sport after tibial shaft fractures.Data sourcesOVID/MEDLINE (PubMed), EMBASE, CINAHL, Cochrane Collaboration Database, Web of Science, PEDro, SPORTDiscus, Scopus, and Google Scholar were all searched for articles published from 1988 to 2014.Study selectionInclusion criteria comprised studies of level 1 to 4 evidence, written in the English language, that reported on the management and outcome of tibial shaft fractures and included data on either return-to-sport rate or time. Studies that failed to report on sporting outcomes, those of level 5 evidence, and those in non-English language were excluded.Study designSystematic review.Level of evidenceLevel 4.Data extractionThe search used combinations of the terms tibial, tibia, acute, fracture, athletes, sports, nonoperative, conservative, operative, and return to sport. Two authors independently reviewed the selected articles and created separate data sets, which were subsequently combined for final analysis.ResultsA total of 16 studies (10 retrospective, 3 prospective, 3 randomized controlled trials) were included (n = 889 patients). Seventy-six percent (672/889) of the patients were men, with a mean age of 27.7 years. Surgical management was assessed in 14 studies, and nonsurgical management was assessed in 8 studies. Return to sport ranged from 12 to 54 weeks after surgical intervention and from 28 to 182 weeks after nonsurgical management (mean difference, 69.5 weeks; 95% CI, -83.36 to -55.64; P < 0.01). Fractures treated surgically had a return-to-sport rate of 92%, whereas those treated nonsurgically had a return rate of 67% (risk ratio, 1.37; 95% CI, 1.20 to 1.57; P < 0.01).ConclusionThe general principles are to undertake surgical management for displaced fractures and to attempt nonsurgical management for undisplaced fractures. Primary surgical intervention of undisplaced fractures, however, may result in higher return rates and shorter return times, though this exposes the patient to the risk of surgical complications, which include surgical site infection and compartment syndrome.

Project description:Open tibial fractures are complex injuries with variable outcomes that significantly impact patients' lives. Surgical debridement is paramount in preventing detrimental complications such as infection and non-union; however, the exact timing of debridement remains a topic of great controversy. The aim of this study is to evaluate the association between timing of surgical debridement and outcomes such as infection and non-union in open tibial fractures. We performed a systematic review and meta-analysis of the literature to capture studies evaluating the association between timing of initial surgical debridement and infection or non-union, or other reported outcomes. We searched the MEDLINE, PubMed Central, EMBASE, SCOPUS, Cochrane Central and Web of Science electronic databases. Our methodology was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Cochrane handbook for systematic reviews of interventions. The systematic review included 20 studies with 10,032 open tibial fractures. The overall infection rate was 14.3% (314 out of 2193) and the overall non-union rate 14.2% (116 out of 817). We did not find any statistically significant association between delayed debridement and infection rate (OR = 0.87; 95% CI, 0.68 to 1.11; p = 0.23) or non-union rate (OR = 0.70; 95% CI, 0.42 to 1.15; p = 0.13). These findings did not change when we accounted for the effect of different time thresholds used for defining early and late debridement, nor with the Gustilo-Anderson classification or varying study characteristics. The findings of this meta-analysis support that delayed surgical debridement does not increase the infection or non-union rates in open tibial fracture injuries. Consequently, we propose that a reasonable delay in the initial debridement is acceptable to ensure that optimal management conditions are in place, such that the availability of surgical expertise, skilled staff and equipment are prioritised over getting to surgery rapidly. We recommend changing the standard guidance around timing for performing surgical debridement to 'as soon as reasonably possible, once appropriate personnel and equipment are available; ideally within 24-h'.

Project description:BackgroundThere remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.MethodsWe conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.ResultsOne thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).ConclusionsThe present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.

Project description:IntroductionMetacarpal shaft fractures (MSF) are common traumatic hand injuries that usually affect young people of working age. They place a significant burden on healthcare resources and society; however, there is a lack of evidence to guide their treatment. Identifying the most beneficial and cost-efficient treatment will ensure optimisation of care and provide economic value for the National Health Service. The aim of this study is to assess the feasibility of a randomised controlled trial comparing surgical and non-surgical treatment for MSF in adults.Methods and analysisThis is a multicentre prospective cohort study, with a nested qualitative study consisting of patient interviews and focus groups, and an embedded factorial randomised substudy evaluating the use of text messages to maximise data collection and participant retention. The outcomes of interest include eligibility, recruitment and retention rates, completion of follow-up, evaluation of primary outcome measures, calculation of the minimal clinically important difference (MCID) for selected outcome measures and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. Data will be captured using a secure online data management system. Data analyses will be descriptive and a thematic inductive analysis will be used for qualitative data. Minimum clinically important effects for each patient-reported outcome measure will be estimated using anchor-based responsiveness statistics and distribution-based methods.Ethics and disseminationThis study has received ethical approval from the Research Ethics Committee and the Health Research Authority (REC reference 20/EE/0124). Results will be made available to patients, clinicians, researchers and the funder via peer-reviewed publications and conference presentations. Social media platforms, local media and feedback from the Patient Advisory Group will be used to maximise circulation of findings to patients and the public.Trial registration numberISRCTN13922779.

Project description:BackgroundOpen tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.MethodsWe conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).ResultsOf the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).ConclusionsTo our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Which Surgical Treatment for Open Tibial Shaft Fractures Results in the Fewest Reoperations? A Network Meta-analysis.

Background

Questions/purposes

Methods

Results

Conclusion

Level of evidence

Publications

Which Surgical Treatment for Open Tibial Shaft Fractures Results in the Fewest Reoperations? A Network Meta-analysis.

Similar Datasets

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