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Bone & Joint Open Oct 2022To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.
AIMS
To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.
METHODS
Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.
RESULTS
Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications).
CONCLUSION
Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required.Cite this article: 2022;3(10):832-840.
PubMed: 36274288
DOI: 10.1302/2633-1462.310.BJO-2022-0080.R1 -
Diabetology & Metabolic Syndrome Aug 2021Diabetes mellitus (DM) causes excess risk of fracture at varied sites. Whereas, the difference between the roles of types 1 DM (T1DM) and 2 DM (T2DM) diabetes in the...
BACKGROUND
Diabetes mellitus (DM) causes excess risk of fracture at varied sites. Whereas, the difference between the roles of types 1 DM (T1DM) and 2 DM (T2DM) diabetes in the risk of fractures remains limited and inconclusive. We, therefore, conducted a meta-analysis to assess the differences for the associations of T1DM and T2DM with the risk of fractures.
METHODS
We systematically searched PubMed, Embase, and the Cochrane library for eligible studies until May 2021. The odds ratios (ORs) with 95% confidence intervals (CIs) were used to calculate the pooled effect estimates for the associations of T1DM and T2DM with the risk of fractures using the random-effects model. An indirect comparison results for the ratio of OR (ROR) with 95% CI were also applied to assess the difference between T1DM and T2DM with the risk of fractures.
RESULTS
Twenty-two cohort studies involving a total of 6,484,851 individuals were selected for meta-analysis. We noted that T1DM was associated with an increased risk of all fractures (OR: 1.72; 95% CI 1.36-2.19; P < 0.001), and fractures at the hip (OR: 4.01; 95% CI 2.90-5.54; P < 0.001), upper arm (OR: 2.20; 95% CI 1.61-3.00; P < 0.001), ankle (OR: 1.97; 95% CI 1.24-3.14; P = 0.004), and vertebrae (OR: 2.18; 95% CI 1.85-2.57; P < 0.001). Moreover, T2DM induced excess risk to all fractures (OR: 1.19; 95% CI 1.09-1.31; P < 0.001), including fractures at the hip (OR: 1.25; 95% CI 1.15-1.35; P < 0.001), upper arm (OR: 1.42; 95% CI 1.20-1.67; P < 0.001), and ankle (OR: 1.15; 95% CI 1.01-1.31; P = 0.029). Furthermore, we noted that T1DM versus T2DM was associated with greater risk to all fractures (ROR: 1.45; 95% CI 1.12-1.87; P = 0.005), including fractures at the hip (ROR: 3.21; 95% CI 2.30-4.48; P < 0.001), upper arm (ROR: 1.55; 95% CI 1.09-2.20; P = 0.015), and ankle (ROR: 1.71; 95% CI 1.06-2.78; P = 0.029).
CONCLUSIONS
This study found that T1DM caused an excess risk to all fractures, including fractures at the hip, upper arm, and ankle than T2DM. Further studies should therefore be conducted to directly compare the differences between T1DM and T2DM with the risk of fractures at various sites.
PubMed: 34399851
DOI: 10.1186/s13098-021-00687-8 -
Injury Feb 2022Supination-external rotation (SER) ankle fractures account for the majority of ankle fractures and can be divided into stable or unstable fractures, based on the state... (Meta-Analysis)
Meta-Analysis
Diagnostic tools to evaluate ankle instability caused by a deltoid ligament rupture in patients with supination-external rotation ankle fractures: A systematic review and meta-analysis.
AIM
Supination-external rotation (SER) ankle fractures account for the majority of ankle fractures and can be divided into stable or unstable fractures, based on the state of the deltoid ligament. The objective of this review was to appraise the available literature concerning diagnostic tools to evaluate deltoid ligament integrity in patients with SER-type ankle fractures.
METHODS
A comprehensive literature search of Pubmed and Embase was performed up to December 2020. The outcome measures were sensitivity, specificity and positive and negative predictive value of the diagnostic tools. A meta-analysis was performed to obtain an overview of sensitivity, specificity and area under the curve (AUC). The methodological quality of the articles was evaluated using Quality Assessment of Diagnostic Accuracy Studies.
RESULTS
A total of 12 studies investigating tools for deltoid ligament rupture in patients with SER-type ankle fractures were included. The present study found sensitivity (and specificity) ranges of 0.20-0.90 (and 0.38-0.97) for clinical features, Magnetic Resonance Imaging (MRI) 0.57-0.85 (and 0.81-1.00), ultrasonography 1.00 (and 0.89-1.00), Malleolar Medial Fleck Sign (MMFS) 0.25 (and 0.99), conventional ankle mortise radiography 0.33-0.57 (and 0.60-0.94), gravity stress radiography 0.71-1.00 (and 0.72-0.88) and manual stress ankle radiography 0.65-1.00 (and 0.00-0.77). The largest AUC was found for ultrasonography, followed by MMFS, gravity stress radiography and MRI.
CONCLUSION
Ultrasonography and gravity stress radiography seem the most accurate diagnostic tools to evaluate deltoid ligament integrity. To strengthen this conclusion, future research should use an identical reference test to ensure comparability of results. Nevertheless, present study is of high value to close the knowledge gap about which presently available diagnostic tool is to be preferred to evaluate deltoid ligament integrity in patients with SER-type ankle fractures.
Topics: Ankle; Ankle Fractures; Ankle Joint; Humans; Ligaments, Articular; Range of Motion, Articular; Supination
PubMed: 34602247
DOI: 10.1016/j.injury.2021.09.034 -
European Journal of Trauma and... Oct 2023There is currently no consensus on nonoperative management in adult patients after a stable type B ankle fracture. The aim of this review is to compare a removable... (Meta-Analysis)
Meta-Analysis
PURPOSE
There is currently no consensus on nonoperative management in adult patients after a stable type B ankle fracture. The aim of this review is to compare a removable orthosis versus a cast regarding safety and functional outcome in the NOM of stable type B ankle fractures.
METHODS
A systematic review and meta-analysis were performed using randomized clinical trials and observational studies. The methodological quality of the included studies was assessed with the methodological index for non-randomized studies instrument. Nonoperative management was compared using the number of complications and functional outcome measured using the Olerud and Molander Score (OMAS) or the American Academy of Orthopaedic Surgeons Ankle Score.
RESULTS
Five studies were included. Two were randomized clinical trials, and three were observational studies, including a total of 516 patients. A meta-analysis showed statistically significant higher odds of developing complications in the cast group [odds ratio (OR), 4.67 (95% confidence interval (CI) 1.52-14.35)]. Functional outcome in OMAS did not vary significantly at 6 weeks, mean difference (MD) - 6.64 (95% CI - 13.72 to + 0.45), and at 12 weeks, MD - 6.91 (95% CI - 18.73 to + 4.91). The mean difference of functional outcome in OMAS at 26 weeks or longer was significantly better in the removable orthosis group; MD - 2.63 (95% CI - 5.01 to - 0.25).
CONCLUSION
Results of this systematic review and meta-analysis show that a removable orthosis is a safe alternative type of NOM, as complication numbers are significantly lower in the orthosis group. In addition, no statistically significant differences were found in terms of functional outcome between a removable orthosis and a cast at 6 and 12 weeks. The 6-week and the 26-week OMAS results show that in patients with stable type B ankle fractures, a removable orthosis is non-inferior to a cast in terms of functional outcome.
Topics: Adult; Humans; Ankle Fractures; Ankle; Orthotic Devices; Braces; Ankle Injuries; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 36383226
DOI: 10.1007/s00068-022-02169-6 -
European Journal of Orthopaedic Surgery... Apr 2023Ankle fractures may cause disability and socioeconomic challenges, even when managed in a high-resource setting. The outcomes of ankle fractures in sub-Saharan Africa...
PURPOSE
Ankle fractures may cause disability and socioeconomic challenges, even when managed in a high-resource setting. The outcomes of ankle fractures in sub-Saharan Africa are not widely reported. We present a systematic review of the patient-reported outcomes and complications of patients treated for ankle fractures in sub-Saharan Africa.
METHODS
Medline, Embase, Google Scholar and the Cochrane Central Register of Controlled Trials were searched, utilising MeSH headings and Boolean search strategies. Ten papers were included. Data included patient demographics, surgical and non-surgical management, patient-reported outcome measures and evidence of complications.
RESULTS
A total of 555 patients with ankle fractures were included, 471 of whom were followed up (range 6 weeks-73 months). A heterogenous mix of low-quality observational studies and two methodologically poor-quality randomised trials demonstrated mixed outcomes. A preference for surgical management was found within the published studies with 87% of closed fractures being treated operatively. A total of five different outcome scoring systems were used. Most studies included in this review were published by well-resourced organisations and as such are not representative of the actual clinical practice taking place.
CONCLUSION
The literature surrounding the clinical outcomes of ankle fractures in sub-Saharan Africa is sparse. There appears to be a preference for surgical fixation in the published literature and considering the limitations in surgical resources across sub-Saharan Africa this may not be representative of real-life care in the region.
Topics: Humans; Ankle Fractures; Fracture Fixation; Africa South of the Sahara
PubMed: 36242674
DOI: 10.1007/s00590-022-03397-7 -
PloS One 2021The association between obesity and fracture risk may be skeletal site- and sex-specific but results among studies are inconsistent. Whilst several studies reported... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
The association between obesity and fracture risk may be skeletal site- and sex-specific but results among studies are inconsistent. Whilst several studies reported higher bone mineral density (BMD) in patients with obesity, altered bone quality could be a major determinant of bone fragility in this population.
OBJECTIVES
This systematic review and meta-analysis aimed to compare, in men, premenopausal women and postmenopausal women with obesity vs. individuals without obesity: 1) the incidence of fractures overall and by site; 2) BMD; and 3) bone quality parameters (circulating bone turnover markers and bone microarchitecture and strength by advanced imaging techniques).
DATA SOURCES
PubMed (MEDLINE), EMBASE, Cochrane Library and Web of Science were searched from inception of databases until the 13th of January 2021.
DATA SYNTHESIS
Each outcome was stratified by sex and menopausal status in women. The meta-analysis was performed using a random-effect model with inverse-variance method. The risks of hip and wrist fracture were reduced by 25% (n = 8: RR = 0.75, 95% CI: 0.62, 0.91, P = 0.003, I2 = 95%) and 15% (n = 2 studies: RR = 0.85, 95% CI: 0.81, 0.88), respectively, while ankle fracture risk was increased by 60% (n = 2 studies: RR = 1.60, 95% CI: 1.52, 1.68) in postmenopausal women with obesity compared with those without obesity. In men with obesity, hip fracture risk was decreased by 41% (n = 5 studies: RR = 0.59, 95% CI: 0.44, 0.79). Obesity was associated with increased BMD, better bone microarchitecture and strength, and generally lower or unchanged circulating bone resorption, formation and osteocyte markers. However, heterogeneity among studies was high for most outcomes, and overall quality of evidence was very low to low for all outcomes.
CONCLUSIONS
This meta-analysis highlights areas for future research including the need for site-specific fracture studies, especially in men and premenopausal women, and studies comparing bone microarchitecture between individuals with and without obesity.
SYSTEMATIC REVIEW REGISTRATION NUMBER
CRD42020159189.
Topics: Female; Humans; Male; Bone Density; Bone Density Conservation Agents; Data Management; Obesity; Osteoporosis, Postmenopausal
PubMed: 34101735
DOI: 10.1371/journal.pone.0252487 -
Archives of Orthopaedic and Trauma... Jan 2021Despite successful osteosynthesis, some patients report residual symptoms after ankle fractures. One of the reasons behind the postoperative complaints might be... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Despite successful osteosynthesis, some patients report residual symptoms after ankle fractures. One of the reasons behind the postoperative complaints might be traumatic concomitant chondral lesions (CL) and/or osteochondral lesions (OCL) within the ankle joint. The study aims to systematically review the incidence of CL and/or OCL in ankle fractures and to assess their effect on the clinical outcome.
MATERIALS AND METHODS
This work was conducted according to PRISMA checklists. A systematic literature search was performed using following keywords: "Ankle Fractures" OR "Trimalleolar Fracture" OR "Bimalleolar Fracture" OR "Maisonneuve fracture" OR "Malleolus Fracture" AND "Cartilage" OR "Cartilage Diseases" OR "Cartilage, Articular" OR "chondral" up to March 2020. The identified articles were analysed to determine the incidence of CL and/or OCL. Included studies in the meta-analysis assessed possible cartilage damage through arthroscopy or MRI immediately after traumatic ankle fractures and described the postoperative clinical outcome.
RESULTS
The search identified a total of 111 publications; 19 described the incidence of CL and/or OCL after ankle fractures; six met the criteria to be included in the meta-analysis: five (n = 293) diagnosed CL and/or OCL through arthroscopy during ORIF and one study (n = 153) used preoperative MRI. The clinical outcome was evaluated in four studies (n = 177) using AOFAS score and in two (n = 269) using FAOS score. The mean incidence of arthroscopically detected CL and/or OCL was 65 ± 21% [95% CI 53.9 to 76.72]. The cumulative meta-analysis sample size comprised a total of 400 Patients (170 with and 230 without CL and/or OCL) available for a mean follow-up of 23.9 ± 11.5 months [95% CI 11.79 to 36.07]. The average age was 44.3 ± 5.5 years [95% CI 38.57 to 50.13]. The meta-analysis revealed a mean AOFAS score of 91.2 ± 4.8 [95% CI 83.53 to 98.93] with versus 94.4 ± 4.7 [95% CI 86.81 to 102.07] without CL and/or OCL (p = 0.15) and a mean FAOS score of 73.2 ± 11.31 [95% CI - 28.44 to 174.85] with versus 79.0 ± 18.4 [95% CI - 86.77 to 244.87] without CL and/or OCL (p = 0.18).
CONCLUSIONS
CL and/or OCL appear very frequently after ankle fractures. A tendency towards a favourable short- to mid-term clinical outcome was noticed in ankle fractures without CL and/or OCL, however without reaching statistical significance.
LEVEL OF EVIDENCE
Level I.
Topics: Adult; Ankle Fractures; Ankle Joint; Arthralgia; Cartilage Diseases; Humans; Incidence; Middle Aged; Pain, Postoperative; Treatment Outcome
PubMed: 33128607
DOI: 10.1007/s00402-020-03647-5 -
International Wound Journal Jan 2024The present systematic review and meta-analysis aimed to determine the prevalence of surgical site infection (SSI) and related factors in patients after foot and ankle... (Meta-Analysis)
Meta-Analysis Review
The present systematic review and meta-analysis aimed to determine the prevalence of surgical site infection (SSI) and related factors in patients after foot and ankle surgery. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex and Scientific Information Database (SID) using keywords extracted from Medical Subject Headings such as 'Prevalence', 'Surgical wound infection', 'Surgical site infection' and 'Orthopaedics' from the earliest to 1 June 2023. The appraisal tool for cross-sectional studies (AXIS tool) evaluates the quality of the included studies. A total of 10 447 patients undergoing foot and ankle surgery participated in nine studies. The pooled prevalence of SSI in patients who underwent foot and ankle surgery was reported in nine studies was 4.2% (95% CI: 2.4%-7.2%; I = 96.793%; p < 0.001). The odds ratio of SSI prevalence in men was higher than that of women and was significant (OR: 1.335; 95% CI: 1.106-1.612; Z = 3.009; p = 0.003). The pooled prevalence of SSI in patients with hindfoot fracture sites reported in five studies was 4.9% (95% CI: 2.6%-8.9%; I = 90.768%; p < 0.001). The pooled prevalence of SSI in patients with diabetes mellitus (DM) reported in six studies was 9.1% (95% CI: 5.6%-14.6%; I = 73.957%; p = 0.002). The pooled prevalence of SSI in patients with hypertension (HTN) reported in five studies was 5.5% (95% CI: 2.5%-11.6%; I = 91.346%; p < 0.001). The pooled prevalence of SSI in patients with tobacco use reported in eight studies was 6.6% (95% CI: 4.1%-10.4%; I = 85.379%; p < 0.001). In general, the existing differences in the prevalence of SSI after foot and ankle surgery in different studies can be based on different risk factors such as comorbidities and gender. Therefore, it is suggested to design appropriate interventions to reduce SSI in these patients.
Topics: Male; Humans; Female; Surgical Wound Infection; Ankle; Prevalence; Cross-Sectional Studies; Risk Factors
PubMed: 37606302
DOI: 10.1111/iwj.14350 -
European Journal of Trauma and... Feb 2024The systematic review aims to establish the value of using 3D printing-assisted pre-operative planning, compared to conventional planning, for the operative management... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The systematic review aims to establish the value of using 3D printing-assisted pre-operative planning, compared to conventional planning, for the operative management of foot and ankle fractures.
METHODS
The systematic review was performed according to PRISMA guidelines. Two authors performed searches on three electronic databases. Studies were included if they conformed to pre-established eligibility criteria. Primary outcome measures included intraoperative blood loss, operation duration, and fluoroscopy time. The American orthopaedic foot and ankle score (AOFAS) was used as a secondary outcome. Quality assessment was completed using the Cochrane RoB2 form and a meta-analysis was performed to assess heterogeneity.
RESULTS
Five studies met the inclusion and exclusion criteria and were eventually included in the review. A meta-analysis established that using 3D printed models for pre-operative planning resulted in a significant reduction in operation duration (mean difference [MD] = - 23.52 min, 95% CI [- 39.31, - 7.74], p = 0.003), intraoperative blood loss (MD = - 30.59 mL, 95% CI [- 46.31, - 14.87], p = 0.0001), and number of times fluoroscopy was used (MD = - 3.20 times, 95% CI [- 4.69, - 1.72], p < 0.0001). Using 3D printed models also significantly increased AOFAS score results (MD = 2.24, 95% CI [0.69, 3.78], p = 0.005), demonstrating improved ankle health.
CONCLUSION
The systematic review provides promising evidence that 3D printing-assisted surgery significantly improves treatment for foot and ankle fractures in terms of operation duration, intraoperative blood loss, number of times fluoroscopy was used intraoperatively, and improved overall ankle health as measured by the AOFAS score.
Topics: Humans; Ankle Fractures; Ankle; Blood Loss, Surgical; Fracture Fixation; Treatment Outcome; Printing, Three-Dimensional; Fracture Fixation, Internal
PubMed: 36418394
DOI: 10.1007/s00068-022-02176-7 -
Foot & Ankle International Aug 2023The best treatment strategy for fractures to the posterior malleolus (PM) is still intensively debated. The aim of this systematic review was to compare the...
BACKGROUND
The best treatment strategy for fractures to the posterior malleolus (PM) is still intensively debated. The aim of this systematic review was to compare the patient-rated outcome following open reduction and internal fixation (ORIF) for fractures of the PM to either closed reduction using AP screws (CRIF) or no treatment in bi- or trimalleolar ankle fractures.
METHODS
Systematic literature research (MEDLINE (PubMed), CINAHL, Scopus, Central and EMBASE) according to the PICOS and PRISMA guidelines. Eligible were studies comparing the outcome following ORIF to any other treatment strategy for fractures to the posterior malleolus in isolated bi- or trimalleolar ankle fractures.
RESULTS
Twelve studies were eligible for a qualitative analysis and 6 for a quantitative analysis. Overall, a considerable heterogeneity among the studies was observed. The most commonly used outcome score was the American Orthopaedic Foot & Ankle Society ankle-hindfoot score (AOFAS). The final follow-up ranged from 12 to 160 months. Four studies compared ORIF to CRIF of the PM. The quantitative analysis revealed significantly better AOFAS scores for ORIF (90.9 vs 83.4 points; < .001; = 0%). Three studies compared ORIF to untreated PM fragment. The quantitative analysis again revealed superior AOFAS scores for ORIF (92.0 vs 82.5 points; < .001; = 99%). A similar trend was observed for the Ankle Fracture Scoring System and American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire scores as well as the quality of reduction.
CONCLUSION
Despite a considerable heterogeneity, the data available point to a superior outcome following ORIF for fractures to the PM when compared to CRIF or no treatment.
Topics: Humans; Ankle Fractures; Treatment Outcome; Fracture Fixation, Internal; Open Fracture Reduction; Ankle Joint; Retrospective Studies
PubMed: 37125766
DOI: 10.1177/10711007231165771