RESUMO
INTRODUCTION: Hip fractures treated with total hip arthroplasty (THA) are at high risk of prosthesis instability, and dislocation is the most common indication for revision surgery. This study aims to determine whether dual mobility THA implants reduce the risk of dislocation compared with conventional THA in patients with hip fracture suitable to be treated with THA. METHODS AND ANALYSIS: This is a cluster-randomised, crossover, open-label trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will comprise hospitals that perform at least 12 THAs for hip fracture per annum. All adults age ≥50 years who meet the Australian and New Zealand Hip Fracture Registry guidelines for THA will be included. The intervention will be dual mobility THA and the comparator will be conventional THA. Each hospital will be allocated to two consecutive periods, one of dual mobility THA and the other of conventional THA in random order, aiming for an average of 16 patients eligible for the primary analysis per group (32 total per site), allowing different recruitment totals between sites. Data will be collected through the AOANJRR and linked with patient-level discharge data acquired through government agencies. The primary outcome is dislocation within 1 year. Secondary outcomes include revision surgery for dislocation and all-cause, complications and mortality at 1, 2 and 5 years. If dual mobility THA is found to be superior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 1536 patients from at least 48 hospitals over 3 years. ETHICS AND DISSEMINATION: Ethics approval has been granted (Sydney Local Health District - Royal Prince Alfred Hospital Zone (approval X20-0162 and 2020/ETH00680) and site-specific approvals). Participant recruitment is via an opt-out consent process as both treatments are considered accepted, standard practice. The trial is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network. TRIAL REGISTRATION NUMBER: ACTRN12621000069853.
Assuntos
Artroplastia de Quadril , Fraturas do Colo Femoral , Fraturas do Quadril , Prótese de Quadril , Adulto , Artroplastia de Quadril/efeitos adversos , Austrália , Estudos Cross-Over , Fraturas do Colo Femoral/cirurgia , Fraturas do Quadril/cirurgia , Prótese de Quadril/efeitos adversos , Humanos , Pessoa de Meia-Idade , Desenho de Prótese , Falha de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , ReoperaçãoRESUMO
BACKGROUND: Dual-mobility cups in THA were designed to reduce prosthesis instability and the subsequent risk of revision surgery in high-risk patients, such as those with hip fractures. However, there are limited data from clinical studies reporting a revision benefit of dual-mobility over conventional THA. Collaboration between anthroplasty registries provides an opportunity to describe international practice variation and compare between-country, all-cause revision rates for dual-mobility and conventional THA. QUESTIONS/PURPOSES: We summarized observational data from multiple arthroplasty registries for patients receiving either a dual-mobility or conventional THA to ask: (1) Is dual-mobility use associated with a difference in risk of all-cause revision surgery compared with conventional THA? (2) Are there specific patient characteristics associated with dual-mobility use in the hip fracture population? (3) Has the use of dual-mobility constructs changed over time in patients receiving a THA for hip fracture? METHODS: Six member registries of the International Society of Arthroplasty Registries (from Australia, Denmark, Sweden, the Netherlands, the United Kingdom, and the United States) provided custom aggregate data reports stratified by acetabular cup type (dual-mobility or conventional THA) in primary THA for hip fracture between January 1, 2002, and December 31, 2019; surgical approach; and patient demographic data (sex, mean age, American Society of Anesthesiologists class, and BMI). The cumulative percent revision and mortality were calculated for each registry. To determine a global hazard ratio of all-cause revision for dual-mobility compared with conventional THA designs, we used a pseudoindividual patient data approach to pool Kaplan-Meier prosthesis revision data from each registry and perform a meta-analysis. The pseudoindividual patient data approach is a validated technique for meta-analysis of aggregate time-to-event survival data, such as revision surgery, from multiple sources. Data were available for 15,024 dual-mobility THAs and 97,200 conventional THAs performed for hip fractures during the study period. RESULTS: After pooling of complete Kaplan-Meier survival data from all six registries, the cumulative percent revision for conventional THA was 4.3% (95% confidence interval [CI] 4.2% to 4.5%) and 4.7% (95% CI 4.3% to 5.3%) for dual-mobility THA at 5 years. We did not demonstrate a lower risk of all-cause revision for patients receiving dual-mobility over conventional THA designs for hip fracture in the meta-analysis once between-registry differences were adjusted for (HR 0.96 [95% CI 0.86 to 1.06]). A lower proportion of dual-mobility procedures were revised for dislocation than conventional THAs (0.9% versus 1.4%) but a higher proportion were revised for infection (1.2% versus 0.8%). In most registries, a greater proportion of dual-mobility THA patients were older, had more comorbidities, and underwent a posterior approach compared with conventional THA (p < 0.001). The proportion of dual-mobility THA used to treat hip fractures increased in each registry over time and constituted 21% (2438 of 11,874) of all THA procedures in 2019. CONCLUSION: The proportion of dual-mobility THAs in patients with hip fractures increased over time, but there was large variation in use across countries represented here. Dual-mobility cups were not associated with a reduction in the overall risk of revision surgery in patients with hip fractures. A randomized controlled trial powered to detect the incidence of dislocation and subsequent revision surgery is required to clarify the efficacy of dual-mobility cups to treat hip fractures. LEVEL OF EVIDENCE: Level III, therapeutic study.
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Artroplastia de Quadril , Fraturas do Colo Femoral , Fraturas do Quadril , Prótese de Quadril , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/métodos , Fraturas do Colo Femoral/etiologia , Fraturas do Quadril/etiologia , Prótese de Quadril/efeitos adversos , Humanos , Desenho de Prótese , Falha de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Reoperação/efeitos adversos , Fatores de RiscoRESUMO
BACKGROUND: Previous randomized studies have suggested that there is no short-term difference between the risk of revision following total hip arthroplasty (THA) and hemiarthroplasty (HA) for hip fracture in elderly patients. The aim of the present study was to compare the long-term revision rates of primary THA and HA for femoral neck fracture in order to determine whether unipolar or bipolar HA increases the all-cause risk of revision in patients 50 to 79 years old. METHODS: Data for 36,188 patients who underwent primary arthroplasty, including 13,035 unipolar and 8,220 bipolar HAs and 14,863 THAs, from September 1, 1999, to December 31, 2019, were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Unadjusted analyses were performed, as well as analyses adjusted for age, sex, femoral cement, and procedure year. The primary outcome was time to first revision for any cause. Secondary analyses were performed for the reason for revision (i.e., infection, dislocation, and periprosthetic fracture). Instrumental variable analysis of hospital preference (for either HA or THA) was performed in order to mitigate the effect of any unmeasured confounding. All analyses were restricted to hospitals performing at least 10 procedures in the prior year. RESULTS: A total of 18,955 procedures were available for the comparison of modular unipolar HA to THA. Both the adjusted analysis performed with use of Cox proportional hazards (hazard ratio [HR], 1.94; 95% confidence interval [CI], 1.64 to 2.31; p < 0.001) and the instrumental variable analysis (HR, 2.82; 95% CI, 1.89 to 4.22; p < 0.001) demonstrated a higher risk of revision following modular unipolar HA compared with THA from 3 months postoperatively. A total of 13,168 procedures were available for the comparison of bipolar HA to THA. The adjusted analysis performed with use of Cox proportional hazards showed a significantly higher risk of revision for bipolar HA (HR, 1.29; 95% CI, 1.08 to 1.54; p = 0.01). The instrumental variable analysis showed a similar effect size that was not significant (HR, 1.27; 95% CI, 0.91 to 1.78; p = 0.16). CONCLUSIONS: Bipolar HA and THA demonstrated no significant difference in revision risk at long-term follow-up. Unipolar HA demonstrated higher risk of revision from 3 months postoperatively compared to THA. The higher risk of revision for dislocation observed following THA may be offset by the higher risk of revision for acetabular erosion or pain following bipolar HA, resulting in more equivalent revision risk. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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Artroplastia de Quadril , Fraturas do Colo Femoral , Hemiartroplastia , Luxações Articulares , Ortopedia , Idoso , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/métodos , Austrália , Fraturas do Colo Femoral/cirurgia , Hemiartroplastia/métodos , Humanos , Luxações Articulares/cirurgia , Pessoa de Meia-Idade , Sistema de Registros , ReoperaçãoRESUMO
BACKGROUND: Aspirin is perceived to be non-inferior to enoxaparin, a low-molecular-weight heparin, for the prevention of venous thromboembolism (VTE) following elective arthroplasty of the hip or knee and is recommended in clinical guidelines internationally. Previous systematic reviews of aspirin as VTE prophylaxis have been limited by the inclusion of heterogenous studies where aspirin is commenced after the initial high-risk postoperative period. The purpose of this systematic review and meta-analysis was to compare the efficacy and associated harms of aspirin and enoxaparin when used as VTE prophylaxis in the initial postoperative period following elective arthroplasty of the hip or knee. We sought to: (1) to compare the use of aspirin versus enoxaparin following elective joint replacement of the hip or knee on the primary outcomes of incidence of VTE and mortality up to 3 months postoperatively and (2) assess the efficacy of aspirin with respect to secondary outcomes such as major or minor bleeding events. We hypothesised that aspirin would have equivalent efficacy for the prevention of VTE when used as initial prophylactic agent, without increasing harm from bleeding events. PATIENTS AND METHODS: We searched Pubmed, Embase, Medline and Cochrane Central for randomized controlled trials reporting the primary outcomes of VTE incidence and mortality. Secondary outcomes included major (compromise of organ, limb or muscle function requiring unplanned re-operation) and minor bleeding events (wound ooze, minor bleed, infection). Included trials underwent a risk of bias and quality of evidence assessment using the GRADE criteria. RESULTS: Four trials involving 1507 participants who underwent elective lower limb arthroplasty were included. We did not detect a significant difference in overall VTE rates when comparing aspirin versus enoxaparin (RR, 0.84; 95% CI: 0.41 to 1.75; p=0.65). Mortality was reported by one study and no events were recorded. There were no significant differences in the rates of all major (RR, 0.84; 95% CI: 0.08 to 9.16) or minor (RR, 0.77; 95% CI: 0.34 to 1.72) bleeding events between the aspirin and enoxaparin groups. Included trials demonstrated a significant risk of bias, and Low to Very Low quality of evidence for primary outcomes, and Moderate to Very Low for secondary outcomes. CONCLUSION: There is currently a lack of high quality randomised controlled trials supporting the use of aspirin as VTE chemoprophylaxis in the initial postoperative period for both total hip and total knee arthroplasty. The results of this meta-analysis provide cautious endorsement for the position that aspirin is likely a safe alternative to enoxaparin for TKA patients as part of a multimodal enhanced recovery protocol, but care is advised for THA patients owing to a lack of data from trials. Current evidence from randomized controlled trials is generally of low quality, and does not estimate critical event data for VTE incidence or mortality, as well as major and minor bleeding events with sufficient certainty. PROSPERO Registration CRD42018110784. LEVEL OF EVIDENCE: II, systematic review.
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Artroplastia de Quadril , Tromboembolia Venosa , Anticoagulantes/uso terapêutico , Artroplastia de Quadril/efeitos adversos , Aspirina/uso terapêutico , Enoxaparina/uso terapêutico , Heparina de Baixo Peso Molecular , Humanos , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controleRESUMO
BACKGROUND: There remains much international practice variation regarding the choice of a unipolar or bipolar prosthesis design for displaced femoral neck fractures that are treated with hemiarthroplasty. The purpose of the present study was to compare revision rates following primary hemiarthroplasty for femoral neck fracture to determine if the unipolar hemiarthroplasty design increases the risk of revision arthroplasty for all causes. METHODS: Instrumental variable analysis was performed with use of data that had been entered into the Australian Orthopaedic Association National Joint Replacement Registry from September 1, 1999, to December 31, 2018. Sixty-two thousand, eight hundred and seventy-five patients with femoral neck fractures that were treated with primary modular unipolar or bipolar hemiarthroplasty procedure were analyzed. Hospital preference for prosthesis design in the 12 months prior to the index procedure was used as an instrument to adjust for unmeasured confounding. The primary outcome was time to first revision for any cause. Secondary analyses were performed on the reason for revision (infection, dislocation, periprosthetic fracture, or acetabular erosion), the use of cement femoral stem fixation, and the type of stem (polished or matte). RESULTS: Modular unipolar hemiarthroplasty was associated with a higher rate of revision at >2.5 years (hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.46 to 2.36; p < 0.001), but there was no difference between the groups before 2.5 years (HR, 0.98; 95% CI, 0.85 to 1.13; p = 0.79). Protective factors for revision included female sex (HR, 0.82; 95% CI, 0.74 to 0.9), use of cemented fixation (HR, 0.69; 95% CI, 0.62 to 0.77), and surgery performed in a public hospital setting (HR 0.79; 95% CI, 0.70 to 0.89). Modular unipolar prostheses had a greater risk of revision for acetabular erosion, particularly in later time periods (HR at ≥5.5 years, 5.10; 95% CI, 2.40 to 10.83; p < 0.001), while being protective against periprosthetic fractures (HR, 0.72; 95% CI, 0.59 to 0.87; p < 0.001) at all time points. There was no difference in terms of the risk of revision for infection, dislocation, or stem type. CONCLUSIONS: Bipolar hemiarthroplasty designs resulted in a lower risk of revision than unipolar designs. Unipolar hemiarthroplasties are justified for patients with femoral neck fracture and a shorter life expectancy (≤2.5 years). LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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Fraturas do Colo Femoral/cirurgia , Hemiartroplastia/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Prótese de Quadril , Humanos , Masculino , Falha de Prótese , Sistema de Registros , Reoperação , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Subacromial analgesia (SAA) is hypothesized to reduce pain after arthroscopic shoulder surgery by delivering a continuous infusion of local anesthetic directly to the surgical site. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of SAA vs. placebo for pain relief after arthroscopic subacromial shoulder procedures. METHODS: MEDLINE, Embase, PubMed, and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials comparing SAA with placebo after arthroscopic shoulder surgery. Outcomes collected included pain scores (converted to equivalent ordinal visual analog scores; minimal clinically important difference 1.4 cm), oral morphine equivalents used postoperatively, and catheter-related complications. Meta-analysis was performed via a random-effects model. Included trials underwent a risk of bias and quality of evidence assessment. RESULTS: Nine studies involving 459 participants were included. There were no clinically significant changes for pain scores in SAA at 6-, 12-, 24-, and 48-hour postoperative timepoints. Patients receiving SAA used less morphine equivalents of pain medication at 12 hours only (-0.37 mg, 95% confidence interval: -0.63 to -0.11), but there was no significant difference at 24 and 48 hours. There were no major complications (infection or reoperation). Included trials demonstrated a moderate risk-of-bias, and low to very low quality of evidence for primary outcomes. CONCLUSION: Subacromial continuous infusion of local anesthetic does not provide a clinically significant benefit compared with placebo as part of a multimodal analgesia regime after arthroscopic subacromial surgical procedures. Future, high-quality trials are required to further assess the efficacy of SAA against placebo.
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Anestésicos Locais/administração & dosagem , Artroscopia , Cateterismo , Bombas de Infusão , Dor Pós-Operatória/tratamento farmacológico , Articulação do Ombro/cirurgia , Cateteres de Demora , Humanos , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device. METHODS: Study design: A series of all patients treated by the DJBL at our institutions. OUTCOME MEASUREMENTS: Weight loss, biochemical measures, complications. RESULTS: Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg (p < 0.0001) within the first 6 months after explantation. CONCLUSIONS: The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.
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Diabetes Mellitus Tipo 2/cirurgia , Duodenoscopia/instrumentação , Segurança de Equipamentos , Derivação Gástrica/instrumentação , Obesidade Mórbida/cirurgia , Adulto , Glicemia/metabolismo , Remoção de Dispositivo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Duodenoscopia/efeitos adversos , Duodenoscopia/métodos , Duodeno/cirurgia , Feminino , Derivação Gástrica/efeitos adversos , Derivação Gástrica/métodos , Humanos , Insulina/sangue , Jejuno/cirurgia , Masculino , Pessoa de Meia-Idade , Obesidade Mórbida/sangue , Obesidade Mórbida/complicações , Próteses e Implantes/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Redução de PesoRESUMO
BACKGROUND: Alterations in gastrointestinal, pancreatic, and adipose hormone levels may have a greater role in weight loss than initially appreciated. The laparoscopic sleeve gastrectomy (LSG) operation is now the most frequently performed bariatric operation in many countries, but there are relatively few data regarding its molecular effects. We sought to characterize the effect of LSG on fasting plasma levels of selected hormones and on non-esterified fatty acids (NEFA), and to compare these to levels in non-obese control individuals. MATERIALS AND METHODS: The levels of nine plasma hormones were measured using a multiplex bead-based assay at baseline and at 3 months after operation in 11 obese patients undergoing LSG. NEFA levels were also measured. The levels were compared to those for 22 age- and sex-matched non-obese individuals. RESULTS: At baseline, obese patients showed significantly higher expression of C-peptide, insulin, and leptin and significantly lower ghrelin, glucose-dependent insulinotropic peptide (GIP), and resistin compared to non-obese controls (p < 0.05). LSG resulted in a reduction in BMI from 42.5 ± 6.47 kg/m2 at operation to 35.2 ± 5.14 kg/m2 at 3 months (42 % mean excess weight loss, p < 0.001). LSG led to a significant decrease in ghrelin, glucagon-like peptide-1 (GLP-1), glucagon, leptin, plasminogen activator inhibitor-1 (PAI-1), and NEFA. CONCLUSION: LSG induces marked early changes in the fasting levels of factors thought to be important regulators of obesity and metabolic health. These changes differ somewhat from the findings for operations with a malabsorptive component, suggesting that subtle differences exist in the mechanisms of weight loss between LSG and other bariatric operations.
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Adipocinas/sangue , Ácidos Graxos não Esterificados/sangue , Gastrectomia , Hormônios Gastrointestinais/sangue , Obesidade Mórbida/sangue , Obesidade Mórbida/cirurgia , Hormônios Pancreáticos/sangue , Adiposidade , Adulto , Idoso , Estudos de Casos e Controles , Jejum/sangue , Feminino , Gastrectomia/métodos , Gastrectomia/reabilitação , Humanos , Masculino , Pessoa de Meia-Idade , Redução de PesoRESUMO
The diminishing number of hours dedicated to formal instruction in anatomy has led to a debate within medical education as to the level required for safe clinical practice. We provide a review of the current state of anatomical education in Australian medical schools and state the case for national standards. In light of the review presented, council members of the Australian Medical Students' Association voted to affirm that consideration should be given to developing undergraduate learning goals for anatomy, providing a codified medical student position on the teaching of anatomy in Australian medical schools. Crucially, the position states that time-intensive methods of instruction such as dissection should be a rite of passage for medical students in the absence of evidence demonstrating the superiority of modern teaching methods. We believe the bodies with a vested interest in the quality of medical graduates, namely the Australian Medical Council, Medical Deans Australia & New Zealand, and the postgraduate colleges should collaborate and develop clear guidelines that make explicit the core knowledge of anatomy expected of medical graduates at each stage of their career with a view to safe clinical practice. In addition, Australian universities have a role to play in conducting further research into contemporary learning styles and the most efficacious methods of delivering anatomical education.