Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty.

BACKGROUND: Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. METHODS: This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo usual care. The primary outcomes of this pilot trial are to assess the feasibility of participant recruitment, retention, and adherence to the interventions, and key secondary outcomes are persisting pain and opioid use. DISCUSSION: The results of this trial will determine the feasibility of conducting a definitive trial for the implementation of a multicomponent pain pathway to improve pain control and reduce harms using a coordinated approach, while keeping an emphasis on patient centred care and shared decision making. TRIAL REGISTRATION: Prospectively registered in Clinicaltrials.gov (NCT04968132).

Management of Greater Trochanteric Pain Syndrome After Total Hip Arthroplasty: Practice Patterns and Surgeon Attitudes.

INTRODUCTION: Greater trochanteric pain syndrome (GTPS) or trochanteric bursitis is described as pain on the lateral side of the hip that does not involve the hip joint and can be elicited clinically by palpation over the greater trochanter. To date, there remains no consensus on clinical guidelines for either diagnosis or management of GTPS. METHODS: To understand the practice patterns, beliefs, and attitudes relating to the management of GTPS after total hip arthroplasty, a survey was developed and completed by Canadian arthroplasty surgeons. The final survey consisted of 23 questions divided into three sections: 1) screening questions; 2) demographic information; and 3) practice patterns, attitudes, and beliefs. RESULTS: Most surgeons use physical examination alone for diagnosis. A detailed analysis indicates that surgeons primarily treat GTPS with oral anti-inflammatories (57.1%), structured physiotherapy (52.4%), and steroid injections (45.2%). Management options are typically nonsurgical and comprise a combination of either unstructured or targeted physiotherapy, corticosteroid injections, or platelet-rich plasma. DISCUSSION: There remains an absence of clinical consensus for the diagnosis and management of GTPS after total hip arthroplasty. Physical examination is most often relied on, regardless of the availability of imaging aids. While common treatments of GTPS were identified, up to one-third of patients fail initial therapy.

Routine use of antibiotic-laden bone cement in total knee arthroplasty is a cost-effective practice in the single-payer healthcare system.

PURPOSE: The purpose of this study was to determine the cost-effectiveness of antibiotic-laden bone cement (ALBC) in primary total knee arthroplasty (TKA) from the perspective of a single-payer healthcare system. METHODS: A cost-utility analysis (CUA) was performed over a 2-year time horizon comparing primary TKA with either ALBC or regular bone cement (RBC) from the perspective of the single-payer Canadian healthcare system. All costs were in 2020 Canadian dollars. Health utilities were in the form of quality-adjusted life years (QALYs). Model inputs for cost, utilities and probabilities were derived from the literature as well as regional and national databases. One-way deterministic sensitivity analysis was performed. RESULTS: Primary TKA with ALBC was found to be more cost-effective compared to primary TKA with RBC with an incremental cost-effectiveness ratio (ICER) of -3,637.79 CAD/QALY. The use of routine ALBC remained cost-effective even with cost increases of up to 50% per bag of ALBC. TKA with ALBC was no longer cost-effective if the rate of PJI following this practice increased 52%, or the rate of PJI following the use of RBC decreased 27%. CONCLUSIONS: The routine use of ALBC in TKA is a cost-effective practice in the single-payer Canadian healthcare system. This remains to be the case even with a 50% increase in the cost of ALBC. Policy makers and hospital administrators of single-payer healthcare systems can leverage this model to inform their local funding policies. Future prospective reviews and randomized controlled trials from the perspective of various healthcare models can further shed light on this issue. LEVEL OF EVIDENCE: III.

Causes and predictors of failed same-day home discharge following primary hip and knee total joint arthroplasty: a Canadian perspective.

PURPOSE: Same-day home (SDH) discharge in total joint arthroplasty (TJA) has increased in popularity in recent years. The objective of this study was to evaluate the causes and predictors of failed discharges in planned SDH patients. METHODS: A consecutive cohort of patients who underwent total knee (TKA) or total hip arthroplasty (THA) that were scheduled for SDH discharge between 01 April 2019 and 31 March 2021 were retrospectively reviewed. Patient demographics, causes of failed discharge, perioperative variables, 30-day readmissions and 6-month reoperation rates were collected. Multivariate regression analysis was undertaken to identify independent predictors of failed discharge. RESULTS: The cohort consisted of 527 consecutive patients. 101 (19%) patients failed SDH discharge. The leading causes were postoperative hypotension (20%) and patients who were ineligible for the SDH pathway (19%). 2 individual surgeons, later operative start time (OR 1.3; 95% CI, 1.15-1.55; p = 0.001), ASA class IV (OR 3.4; 95% CI, 1.4-8.2; p = 0.006) and undergoing a THA (OR 2.0; 95% CI, 1.2-3.1, p = 0.004) were independent predictors of failed SDH discharge. No differences in age, BMI, gender, surgical approach or type of anaesthetic were found (p > 0.05). The 30-day readmission or 6-month reoperation were similar between groups (p > 0.05). CONCLUSIONS: Hypotension and inappropriate patient selection were the leading causes of failed SDH discharge. Significant variability existed between individual surgeons failed discharge rates. Patients undergoing a THA, classified as ASA IV or had a later operative start time were all more likely to fail SDH discharge.

Risk factors for recurrence of periprosthetic joint infection following operative management: a cohort study with average 5-year follow-up.

Background: Periprosthetic joint infections (PJIs) remain challenging to eradicate even after surgical management, which in most cases involves either debridement, antibiotics and implant retention (DAIR) or single- or two-staged revision. The purpose of this study is to determine predictors of PJI recurrence after operative management for PJI, and to determine differences in recurrence-free survival between DAIR and staged revision. Methods: This is a retrospective analysis of prospectively collected data of revision hip and knee arthroplasty surgeries due to PJI between 2011 and 2018 at an academic hospital. Any patient undergoing revision surgery for PJI was included except if the index surgery information was unknown. The primary outcome was confirmed PJI recurrence. Multivariable logistic regression analysis was utilized to determine the relationship between the predictor variables and outcome variable. Log rank testing was used to compare recurrence-free survival between DAIR and staged revision. Results: A total of 89 patients (91 joints) underwent revision surgery due to PJI. Younger age and presence of a sinus tract were statistically significant for risk of PJI recurrence. A multivariable logistic regression model including both variables was significant for predicting recurrence of PJI (χ2=10.2, P=0.006). Survival was not significantly different between patients who underwent DAIR versus a staged revision. Conclusions: Younger patients and those with a chronic sinus tract are at significantly higher risk of recurrent PJI. This study also demonstrated that PJI can be successfully managed in the majority of cases with DAIR or staged revision.

Unicompartmental Knee Arthroplasty: Survivorship and Risk Factors for Revision: A Population-Based Cohort Study with Minimum 10-Year Follow-up.

BACKGROUND: Operative management for end-stage knee osteoarthritis (OA) primarily consists of arthroplasty. Total knee arthroplasty (TKA) is the so-called gold standard for multicompartmental OA. In selected patients, specifically those with unicompartmental OA and no definite contraindications, realignment osteotomies and unicompartmental knee arthroplasty (UKA) are viable options. UKA offers several advantages over TKA, including preservation of both cruciate ligaments, faster recovery, and less osseous resection. The purpose of this study was to determine the survivorship of UKAs and risk factors for all-cause revision surgery in patients with a minimum follow-up of 10 years in a large population-based database. METHODS: We performed a population-based cohort study using linked administrative databases in Ontario, Canada. We identified all UKAs performed from January 2002 through December 2006. All patients had a minimum 10-year follow-up. Demographic data and outcomes were summarized using descriptive statistics. We used a Cox proportional hazards model with the Fine and Gray method accounting for competing risks such as death to analyze the effect of surgical and patient factors on the risk of revision of UKA. RESULTS: A total of 4,385 patients were identified as having undergone primary UKA from 2002 through 2006 in Ontario. Of these patients, 779 underwent revision surgery, for a cumulative risk for all-cause revision of 16.5% at 10 years (95% confidence interval [CI]: 15.4% to 17.7%). Mechanical loosening was the reason for 83.4% of all revisions. Male sex, diabetes, an age younger than 50 years, and cementless implants were significant risk factors for revision surgery. Residence in a rural or urban setting, income quintile, discharge destination, and type of OA were not associated with the risk of revision. Survivorship at 1, 5, 10, and 15 years was 97.2%, 90.5%, 83.5%, and 81.9%, respectively. CONCLUSIONS: This study demonstrated a >80% long-term survivorship for UKA based on a large administrative database sample and identified important risk factors for failure including male sex, younger age, diabetes, and cementless fixation. This study found rates of survivorship similar to those previously reported in the literature, while identifying key risk factors for failure. Patient selection has always been identified as a key factor in ensuring successful UKA, and the risk factors identified in this study may help guide decision-making for surgeons and patients dealing with unicompartmental knee OA. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The Changing Characteristics of Arthroplasty Patients: A Retrospective Cohort Study.

BACKGROUND: Total joint arthroplasty (TJA) is among the most common operations performed worldwide, with global volumes on the rise. It is important to understand if the characteristics of this patient population are changing over time for resource allocation and surgical planning. The purpose of this study is to examine how this patient population has changed between 2003 and 2017. METHODS: A retrospective review of a prospective TJA database was conducted. Age, gender, body mass index, comorbidities, American Society of Anesthesiologists class, responsible diagnoses, and comorbidities were compared over 5-year intervals between 2003 and 2017. All patients undergoing primary, elective TJA were included. RESULTS: Overall, 17,138 TJAs were included. Mean body mass index increased over the study period for total hip arthroplasty (THA; 29.4-30.4 kg/m2, P < .0001) and total knee arthroplasty (TKA; 32.0-3.1 kg/m2, P < .0001) patients. THA patients were significantly younger in more recent years (68.0-66.8 years old, P = .0026); this trend was not observed among TKA patients. Over the study period, a significantly higher proportion of patients were American Society of Anesthesiologists class III/IV for THA (50.5%-72.3%) and TKA (57.5%-80.7%) (P < .00001). Prevalence of common comorbidities did not change significantly. CONCLUSION: The key findings of this retrospective analysis of a large prospective database are that patients undergoing TJA are becoming younger and more obese. It is unclear whether patients are becoming more medically complex. These trends paint a concerning picture of a population that is increasingly complex, and may require a greater allocation of resources in the future. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Identifying Patients with Osteoarthritis at Risk of Sarcopenia using the SARC-F.

BACKGROUND: Sarcopenia is an important modifiable risk factor in patients being considered for elective knee or hip replacement as it may be associated with a higher risk of post-operative joint replacement complications. Our objectives are to determine the prevalence of patients with osteoarthritis at risk of sarcopenia by using the SARC-F tool, and whether risk of sarcopenia is associated with referral to an orthopaedic surgeon. METHODS: We conducted a retrospective review of patients who were 60 years or older assessed at four Canadian musculoskeletal assessment centres. Patients completed the SARC-F as part of their assessment. Multivariable logistic regression analyses were conducted to determine association between risk of sarcopenia and the odds of referral to an orthopedic surgeon for surgical consultation. RESULTS: 3,697 patients were included and 67.8% (2,508/3,697) were at risk of sarcopenia. Prevalence was highest in those assessed for hip replacement at 72.3% (635/878). Patients at risk of sarcopenia were more likely to be referred to an orthopaedic surgeon (OR 1.299; SD 1.074-1.571). CONCLUSIONS: Patients with osteoarthritis assessed for joint replacement are at high risk of sarcopenia, particularly individuals undergoing potential hip replacement. Patients at risk of sarcopenia are more likely to be referred to orthopaedic surgery for surgical consultation.

Preoperative prediction of Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study.

BACKGROUND: Diagnostic criteria for Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS) have been defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, leads to blood transfusion, or is judged to be the direct cause of death. Preoperative prediction guides for BIMS can facilitate informed consent and planning of perioperative care. METHODS: In a prospective cohort study of 16 079 participants aged ≥45 yr having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011, 17.3% (2782) experienced BIMS. An electronic risk calculator for BIMS was developed and internally validated by logistic regression with bootstrapping, and further simplified to a risk index. Decision curve analysis assessed the potential utility of each prediction guide compared with a strategy of identifying risk of BIMS based on preoperative haemoglobin <120 g L-1. RESULTS: With information about the type of surgery, preoperative haemoglobin, age, sex, functional status, kidney function, history of high-risk coronary artery disease, and active cancer, the risk calculator accurately predicted BIMS (bias-corrected C-statistic, 0.84; 95% confidence interval, 0.837-0.852). A simplified index based on preoperative haemoglobin <120 g L-1, open surgery, and high-risk surgery also predicted BIMS, but less accurately (C-statistic, 0.787; 95% confidence interval, 0.779-0.796). Both prediction guides could improve decision making compared with knowledge of haemoglobin <120 g L-1 alone. CONCLUSIONS: BIMS, defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, leads to blood transfusion, or that is judged to be the direct cause of death, can be predicted by a simple risk index before surgery. CLINICAL TRIAL REGISTRATION: NCT00512109.

Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty.

BACKGROUND: Despite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique. METHODS: We undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction. RESULTS: The sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference >15 pounds, compared to only 5.3% (4/76) within the experimental group (P < .0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992). CONCLUSION: Despite the use of the sensor-guided knee balancer device to provide additional quantitative feedback in the evaluation of the soft tissue envelope during TKA, we were unable to demonstrate improved clinical outcomes or patient satisfaction compared to our conventional gap balancing technique.

Bleeding Independently associated with Mortality after noncardiac Surgery (BIMS): an international prospective cohort study establishing diagnostic criteria and prognostic importance.

BACKGROUND: We aimed to establish diagnostic criteria for bleeding independently associated with mortality after noncardiac surgery (BIMS) defined as bleeding during or within 30 days after noncardiac surgery that is independently associated with mortality within 30 days of surgery, and to estimate the proportion of 30-day postoperative mortality potentially attributable to BIMS. METHODS: This was a prospective cohort study of participants ≥45 yr old having inpatient noncardiac surgery at 12 academic hospitals in eight countries between 2007 and 2011. Cox proportional hazards models evaluated the adjusted relationship between candidate diagnostic criteria for BIMS and all-cause mortality within 30 days of surgery. RESULTS: Of 16 079 participants, 2.0% (315) died and 36.1% (5810) met predefined screening criteria for bleeding. Based on independent association with 30-day mortality, BIMS was identified as bleeding leading to a postoperative haemoglobin <70 g L-1, transfusion of ≥1 unit of red blood cells, or that was judged to be the cause of death. Bleeding independently associated with mortality after noncardiac surgery occurred in 17.3% of patients (2782). Death occurred in 5.8% of patients with BIMS (161/2782), 1.3% (39/3028) who met bleeding screening criteria but not BIMS criteria, and 1.1% (115/10 269) without bleeding. BIMS was associated with mortality (adjusted hazard ratio: 1.87; 95% confidence interval: 1.42-2.47). We estimated the proportion of 30-day postoperative deaths potentially attributable to BIMS to be 20.1-31.9%. CONCLUSIONS: Bleeding independently associated with mortality after noncardiac surgery (BIMS), defined as bleeding that leads to a postoperative haemoglobin <70 g L-1, blood transfusion, or that is judged to be the cause of death, is common and may account for a quarter of deaths after noncardiac surgery. CLINICAL TRIAL REGISTRATION: NCT00512109.

Antibiotic Cement in Arthroplasty: A Meta-analysis of Randomized Controlled Trials.

Introduction Periprosthetic joint infection (PJI) following arthroplasty surgery is a devastating complication. Antibiotic cement has been proposed as a way to reduce PJI rates. The aim of this systematic review and meta-analysis was to review all of the available randomized controlled trial (RCT) evidence on the use of antibiotic cement in arthroplasty. Methods PubMed, MEDLINE, and Embase were searched. All records were screened in triplicate. Eligible RCTs were included. Data regarding study characteristics, patient demographics, and rates of superficial and deep infection were collected. The risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool 2.0. Results Five RCTs were included (n = 4,397). Four studies compared antibiotic cement to plain cement while one study compared high-dose dual-antibiotic (HDDA) cement to low-dose single-antibiotic (LDSA) cement. The mean age of included patients was 76.4 years (range: 68-83). There was no significant difference in superficial infection rates between antibiotic and plain cement (odds ratio (OR): 1.33, 95% Confidence Interval (CI): 0.77-2.30, p = 0.3). There was a large but non-significant reduction in deep infection rates for antibiotic cement (OR: 0.20, 95%CI: 0.03-1.32, p = 0.09). There was a significantly lower rate of infection with HDDA as compared to LDSA (OR: 0.31, 95% CI: 0.09-0.88, p = 0.041). Conclusion The available evidence from RCTs reveals a potential benefit for antibiotic cement in arthroplasty surgery, though this difference is non-significant and highly imprecise. Furthermore, HDDA cement was significantly more effective than LDSA cement. There is a need for large, pragmatic trials on this topic.

Association Between Myocardial Injury and Cardiovascular Outcomes of Orthopaedic Surgery: A Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Substudy.

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is common and of prognostic importance. Little is known about MINS in orthopaedic surgery. The diagnostic criterion for MINS was a level of ≥0.03 ng/mL on a non-high-sensitivity troponin T (TnT) assay due to myocardial ischemia. METHODS: We undertook an international, prospective study of 15,103 patients ≥45 years of age who had inpatient noncardiac surgery; 3,092 underwent orthopaedic surgery. Non-high-sensitivity TnT assays were performed on postoperative days 0, 1, 2, and 3. Among orthopaedic patients, we determined (1) the prognostic relevance of the MINS diagnostic criteria, (2) the 30-day mortality rate for those with and without MINS, and (3) the probable proportion of MINS cases that would go undetected without troponin monitoring because of a lack of an ischemic symptom. RESULTS: Three hundred and sixty-seven orthopaedic patients (11.9%) had MINS. MINS was associated independently with 30-day mortality including among those who had had orthopaedic surgery. Orthopaedic patients without and with MINS had a 30-day mortality rate of 1.0% and 9.8%, respectively (odds ratio [OR], 11.28; 95% confidence interval [CI], 6.72 to 18.92). The 30-day mortality rate was increased for patients with MINS who had an ischemic feature (i.e., symptoms, or evidence of ischemia on electrocardiography or imaging) (OR, 18.25; 95% CI, 10.06 to 33.10) and for those who did not have an ischemic feature (OR, 7.35; 95% CI, 3.37 to 16.01). The proportion of orthopaedic patients with MINS who were asymptomatic and in whom the myocardial injury would have probably gone undetected without TnT monitoring was 81.3% (95% CI, 76.3% to 85.4%). CONCLUSIONS: One in 8 orthopaedic patients in our study had MINS, and MINS was associated with a higher mortality rate regardless of symptoms. Troponin levels should be measured after surgery in at-risk patients because most MINS cases (>80%) are asymptomatic and would go undetected without routine measurements. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Nuisance Symptoms in Total Joint Arthroplasty: Prevalence and Impact on Patient Satisfaction.

BACKGROUND: While hip and knee total joint arthroplasty (TJA) patients experience marked improvement in pain relief and function, many patients experience nuisance symptoms, which may cause discomfort and dissatisfaction. METHODS: A prospective survey study to determine type and prevalence of hip/knee TJA nuisance symptoms and impact on patient satisfaction at 1 year postoperative was conducted. The survey determined occurrence of common nuisance symptoms (eg, localized pain, swelling, instability, stiffness) and impact on overall satisfaction rated on a 10-point visual analog scale (VAS). Survey responses were analyzed using descriptive statistics. RESULTS: The sample comprised 545 TJA patients who completed the survey: 335 knees (61%) and 210 hips (39%). Among knees, the most commonly reported nuisance symptoms and associated impact on satisfaction included difficulty kneeling (78.2%; VAS, 4.3; SD, 3.3), limited ability to run/jump (71.6%; VAS, 3.3; SD, 3.3), and numbness around incision (46.3%; VAS, 3.8; SD, 3.3). Overall, 94% of knee patients experienced at least 1 nuisance symptom at 1 year, reporting mean satisfaction of 9/10 (SD, 1.7). Among hips, the most commonly reported nuisance symptoms and associated impact on satisfaction were limited ability to run/jump (68.6%; VAS, 3.4; SD, 3.4), thigh muscle pain (44.8%; VAS, 3; SD, 2.7), and limp when walking (37.6%; VAS, 4.1; SD, 3.2). Overall, 88% of hip patients experienced at least 1 self-reported nuisance symptom at 1 year, reporting mean satisfaction of 8.9/10 (SD, 1.7). CONCLUSION: Nuisance symptoms after hip/knee TJA are very common. Despite the high prevalence, impact on overall satisfaction is minimal and patient satisfaction remains high. Careful preoperative counseling regarding prevalence is prudent and will help establish realistic expectations following TJA.

Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients.

INTRODUCTION: Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications. METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients. ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

Getting fit for hip and knee replacement: a protocol for the Fit-Joints pilot randomized controlled trial of a multi-modal intervention in frail patients with osteoarthritis.

BACKGROUND: Joint replacement provides significant improvements in pain, physical function, and quality of life in patients with osteoarthritis. With a growing body of evidence indicating that frailty can be treated, it is important to determine whether targeting frailty reduction in hip and knee replacement patients improves post-operative outcomes. OBJECTIVES: The primary objective is to examine the feasibility of a parallel group RCT comparing a preoperative multi-modal frailty intervention to usual care in pre-frail/frail older adults undergoing elective unilateral hip or knee replacements. The secondary objectives areTo explore potential efficacy of the multi-modal frailty intervention in improving frailty and mobility between baseline and 6 weeks post-surgery using Fried frailty phenotype and short performance physical battery (SPPB) respectively.To explore potential efficacy of the multi-modal frailty intervention on post-operative healthcare services use. METHODS/DESIGN: In a parallel group pilot RCT, participants will be recruited from the Regional Joint Assessment Program in Hamilton, Canada. Participants who are (1) ≥ 60 years old; (2) pre-frail (score of 1 or 2) or frail (score of 3-5; Fried frailty phenotype); (3) having elective unilateral hip or knee replacement; and (4) having surgery wait times between 3 and 10 months will be recruited and randomized to either the intervention or usual care group. The multi-modal frailty intervention components will include (1) tailored exercise program (center-based and/or home-based) with education and cognitive behavioral change strategies; (2) protein supplementation; (3) vitamin D supplementation; and (4) medication review. The main comparative analysis will take place at 6 weeks post-operative. The outcome assessors, data entry personnel, and data analysts are blinded to treatment allocation. Assessments: feasibility will be assessed by recruitment rate, retention rate, and data collection completion. Frailty and healthcare use and other clinical outcomes will be assessed. The study outcomes will be collected at the baseline, 1 week pre-operative, and 6 weeks and 6 months post-operative. DISCUSSION: This is the first study to examine the feasibility of multi-modal frailty intervention in pre-frail/frail older adults undergoing hip or knee replacement. This study will inform the planning and designing of multi-modal frailty interventional studies in hip and knee replacement patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02885337.

Bleeding impacting mortality after noncardiac surgery: a protocol to establish diagnostic criteria, estimate prognostic importance, and develop and validate a prediction guide in an international prospective cohort study.

INTRODUCTION: Various definitions of bleeding have been used in perioperative studies without systematic assessment of the diagnostic criteria for their independent association with outcomes important to patients. Our proposed definition of bleeding impacting mortality after noncardiac surgery (BIMS) is bleeding that is independently associated with death during or within 30 days after noncardiac surgery. We describe our analysis plan to sequentially 1) establish the diagnostic criteria for BIMS, 2) estimate the independent contribution of BIMS to 30-day mortality and 3) develop and internally validate a clinical prediction guide to estimate patient-specific risk of BIMS. METHODS: In the Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) study, we prospectively collected bleeding data for 16 079 patients aged 45 years or more who had noncardiac inpatient surgery between 2007 and 2011 at 12 centres in 8 countries across 5 continents. We will include bleeding features independently associated with 30-day mortality in the diagnostic criteria for BIMS. Candidate features will include the need for reoperation due to bleeding, the number of units of erythrocytes transfused, the lowest postoperative hemoglobin concentration, and the absolute and relative decrements in hemoglobin concentration from the preoperative value. We will then estimate the incidence of BIMS and its independent association with 30-day mortality. Last, we will construct and internally validate a clinical prediction guide for BIMS. INTERPRETATION: This study will address an important gap in our knowledge about perioperative bleeding, with implications for the 200 million patients who undergo noncardiac surgery globally every year. Trial registration: ClinicalTrials.gov, no NCT00512109.

Bilateral Osteonecrosis of the Femoral Head During Pregnancy Following Two Corticosteroid Injections: A Case Report and Review of the Literature.

Osteonecrosis of the femoral head during pregnancy, or shortly thereafter, is a rare clinical problem. Little is known about pregnancy as an etiological factor for femoral head osteonecrosis with only 40 reported cases in the literature. Furthermore, single or dual dose steroid-induced multifocal osteonecrosis is a controversial topic with only a handful of published cases. We present a case of a 34-year-old female with bilateral femoral head osteonecrosis that developed during the peripartum period. She received two large intramuscular injections of steroids for fetal lung maturity because early delivery was required as a result of eclampsia. She underwent total arthroplasty of the left hip due to unremitting pain and functional disability, which achieved good clinical results--relieving her pain and improving her range of motion. Literature is scarce with regard to single or dual dose steroid-induced osteonecrosis of the hip as well as pregnancy as a general etiologic factor. This case highlights the need for high clinical suspicion of osteonecrosis as a cause of postpartum hip pain.