Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial.

BACKGROUND: Total knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate partial knee replacements, increasing accuracy and precision. This trial will investigate the feasibility and assess clinical outcomes for a larger definitive trial. METHODS: This is a protocol for an ongoing parallel randomized pilot trial of 64 patients with uni- or bicompartmental knee arthritis. Patients are randomized to either receive robot-assisted partial knee arthroplasty or manual total knee arthroplasty. The primary outcome of this pilot is investigating the feasibility of a larger trial. Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post-surgical pain, re-operations, resource utilization and cost-effectiveness, health-related quality of life, radiographic alignment, knee kinematics during walking gait, and complications up to 24 months post-surgery. DISCUSSION: The RoboKnees pilot study is the first step in determining the outcome of robot-assisted partial knee replacements. Conclusions from this study will be used to design future large-scale trials. This study will inform surgeons about the potential benefits of robot-assisted partial knee replacements. TRIAL REGISTRATION: This study was prospectively registered on clinicaltrials.gov (identifier: NCT04378049) on 4 May 2020, before the first patient was randomized.

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).

Predictors of Persistent Post-Surgical Pain Following Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Observational Studies.

OBJECTIVE: Approximately one in four total knee replacement patients develop persistent pain. Identification of those at higher risk could help inform optimal management. METHODS: We searched MEDLINE, EMBASE, CINAHL, AMED, SPORTDiscus, and PsycINFO for observational studies that explored the association between risk factors and persistent pain (≥3 months) after total knee replacement. We pooled estimates of association for all independent variables reported by >1 study. RESULTS: Thirty studies (26,517 patients) reported the association of 151 independent variables with persistent pain after knee replacement. High certainty evidence demonstrated an increased risk of persistent pain with pain catastrophizing (absolute risk increase [ARI] 23%, 95% confidence interval [CI] 12 to 35), younger age (ARI for every 10-year decrement from age 80, 4%, 95% CI 2 to 6), and moderate-to-severe acute post-operative pain (ARI 30%, 95% CI 20 to 39). Moderate certainty evidence suggested an association with female sex (ARI 7%, 95% CI 3 to 11) and higher pre-operative pain (ARI 35%, 95% CI 7 to 58). Studies did not adjust for both peri-operative pain severity and pain catastrophizing, which are unlikely to be independent. High to moderate certainty evidence demonstrated no association with pre-operative range of motion, body mass index, bilateral or unilateral knee replacement, and American Society of Anesthesiologists score. CONCLUSIONS: Rigorously conducted observational studies are required to establish the relative importance of higher levels of peri-operative pain and pain catastrophizing with persistent pain after knee replacement surgery.

Robotic thoracic surgery in Canada: Are patients willing to pay out of pocket?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective, but is associated with high capital and operating costs that are not reimbursed by the Canadian government. Currently, patients have access to RTS only when it is supported by research or philanthropic funds. In a recent study, we assessed the extent of patient-reported satisfaction with RTS, whether patients would have been willing to pay out of pocket for it, and what factors were associated with patients' willingness to pay. Many patients (290 of 411 [70.56%]) stated that they would have paid the additional $2000 to supplement the government health care coverage to have access to RTS. Factors found to be significantly associated with participants' willingness to pay were an annual income of $60 000 or more (p = 0.034), private insurance coverage (p = 0.007), overall experience with RTS rated as 8 or higher out of 10 (p < 0.001), and overall postoperative postdischarge experience rated as satisfying or very satisfying (p = 0.004).

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): A feasibility randomized controlled trial in knee replacement patients.

Background: Total knee arthroplasties are the second most common surgery in Canada. Most patients recover well, but 20% or more still suffer from persistent pain and opioid use. Though opioids are an important part of perioperative pain management, their potential for long-term adverse effects is well recognized. Limiting opioids may be insufficient to overcome the issue of opioid overuse. Pain and opioid use are highly linked, so an effective alternative needs to address both issues. Objectives: The principal objective of this pilot trial is to assess the feasibility. The clinical objectives are to determine the effects of a multicomponent care pathway on opioid-free pain control, persisting pain and opioid use, functional knee outcomes, quality of life, and return to function. Methods: We will include adult patients scheduled for primary elective total knee arthroplasty. Patients in the intervention group will undergo a multicomponent intervention pathway that will be facilitated by an intervention coordinator linking each patient and their surgical/ perioperative team. The interventional pathway will include (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation using cognitive behavioral skills, (3) personalized postdischarge analgesic prescriptions, and (4) continued support for pain control and recovery up to 8 weeks. Patients in the control group will receive the usual care at their institution. Discussion: The overarching goal is to implement and evaluate a coordinated approach to clinical care to improve pain control and reduce harms, with an emphasis on patient-centered care and shared decision making.Trial Registration Number: NCT04968132 (informed consent/ research ethics board statement).

Contexte: L'arthroplastie totale du genou est la deuxième chirurgie la plus courante au Canada. La plupart des patients se rétablissent bien, mais au moins 20 pour cent d'entre eux souffrent encore de douleur persistante et de consommation d'opioïdes. Bien que les opioïdes soient un élément important de la prise en charge périopératoire de la douleur, leur potentiel d'effets indésirables à long terme est bien reconnu. La limitation des opioïdes peut être insuffisante pour surmonter le problème de la surconsommation d'opioïdes. La douleur et la consommation d'opioïdes sont étroitement liées, de sorte qu'une option de rechange efficace doit s'attaquer à ces deux problèmes.Objectifs: L'objectif principal de cet essai pilote est d'évaluer la faisabilité. Les objectifs cliniques sont de déterminer les effets d'une voie de soins à composantes multiples sur la maitrise de la douleur sans opioïdes, la douleur persistante et la consommation d'opioïdes, les résultats fonctionnels du genou, la qualité de vie et le retour à la fonction.Méthodes: Nous inclurons les patients adultes devant subir une arthroplastie primaire totale élective du genou. Les patients du groupe d'intervention seront soumis à une voie d'intervention à composantes multiples qui sera facilitée par un coordonnateur d'intervention reliant chaque patient et son équipe chirurgicale/périopératoire. La voie d'intervention comprendra (1) une éducation préopératoire sur la douleur et la consommation d'opioïdes, (2) la détermination et l'atténuation des risques préopératoires à l'aide de compétences comportementales cognitives, (3) des prescriptions analgésiques personnalisées après la sortie, et (4) un soutien continu pour la maîtrise de la douleur et la récupération pendant une période allant jusqu'à huit semaines. Les patients du groupe témoin recevront les soins habituels à leur établissement.Discussion: L'objectif global est de mettre en œuvre et d'évaluer une approche coordonnée des soins cliniques afin d'améliorer la maitrise de la douleur et réduire les méfaits, en mettant l'accent sur les soins centrés sur le patient et la prise de décision partagée. Numéro d'enregistrement de l'essai : NCT04968132 (consentement éclairé/déclaration du comité d'éthique de la recherche).

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial.

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.

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.

Differential characteristics and management of pseudoseptic arthritis following hyaluronic acid injection is a rare complication: a systematic review.

IMPORTANCE: Acute pseudoseptic arthritis is a rare complication of hyaluronic acid (HA) injections that is not well documented in the literature. Practitioners initially suspect the symptoms of this complication to represent septic arthritis, cautiously prescribing antibiotics. This review identifies that time to presentation of symptoms postinjection, negative cell cultures and lack of crystallisation could be used as differentials to suspect pseudoseptic arthritis and to prescribe anti-inflammatory drugs while closely monitoring change of symptoms. OBJECTIVE: The purpose of this study was to describe the presentation, diagnosis and treatment of pseudoseptic arthritis. EVIDENCE REVIEW: A systematic review of the literature was conducted for studies reporting the use of HA injections for osteoarthritis resulting in pseudoseptic arthritis using the electronic databases MEDLINE, Embase and PubMed. Pertinent data were abstracted from the search yield. A unique case of a pseudoseptic reaction is also presented. FINDINGS: A total of 11 studies (28 cases), all of level IV and V evidence were included in this review. Reported cases of pseudoseptic arthritis in the literature present with severe joint pain (100%), effusion (100%), inability to weight-bear, functional impairment, and occasionally fever (22.2%). C reactive protein and erythrocyte sedimentation rate are generally elevated (71.4% and 85.7%, respectively), and leucocytosis above 10 000 was less common (50%). All reported cases in the literature identified aseptic growth on arthrocentesis, despite four cases (15.4%) reporting synovial leucocyte counts above 50 000. The presented case is the highest reported leucocyte count at 1 74 960 cells/mm3. CONCLUSIONS AND RELEVANCE: Acute pseudoseptic arthritis is rare, but a number of cases have been reported in the literature. A high degree of suspicion for pseudoseptic arthritis may be maintained in patients who present under 72 hours following HA injection. Initial antibiotic treatment, along with anti-inflammatory medications until cultures are confirmed to be negative at 5 days, is a cautious approach. However, the strength of this conclusion is limited by the few reported cases. Ultimately, this review is intended to inform practitioners of the symptoms, diagnosis and treatment of this complication, such that it could be safely differentiated from septic arthritis. LEVEL OF EVIDENCE: IV.

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.

BACKGROUND: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04344665.

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.

Economic evaluation of robot-assisted radical prostatectomy compared to open radical prostatectomy for prostate cancer treatment in Ontario, Canada.

INTRODUCTION: Recent health technology assessments (HTAs) of robot-assisted radical prostatectomy (RARP) in Ontario and Alberta, Canada, resulted in opposite recommendations, calling into question whether benefits of RARP offset the upfront investment. Therefore, the study objectives were to conduct a cost-utility analysis from a Canadian public payer perspective to determine the cost-effectiveness of RARP. METHODS: Using a 10-year time horizon, a five-state Markov model was developed to compare RARP to open radical prostatectomy (ORP). Clinical parameters were derived from Canadian observational studies and a recently published systematic review. Costs, resource utilization, and utility values from recent Canadian sources were used to populate the model. Results were presented in terms of increment costs per quality-adjusted life years (QALYs) gained. A probabilistic analysis was conducted, and uncertainty was represented using cost-effectiveness acceptability curves (CEACs). One-way sensitivity analyses were also conducted. Future costs and QALYs were discounted at 1.5%. RESULTS: Total cost of RARP and ORP were $47 033 and $45 332, respectively. Total estimated QALYs were 7.2047 and 7.1385 for RARP and ORP, respectively. The estimated incremental cost-utility ratio (ICUR) was $25 704 in the base-case analysis. At a willingness-to-pay threshold of $50 000 and $100 000 per QALY gained, the probability of RARP being cost-effective was 0.65 and 0.85, respectively. The model was most sensitive to the time horizon. CONCLUSIONS: The results of this analysis suggest that RARP is likely to be cost-effective in this Canadian patient population. The results are consistent with Alberta's HTA recommendation and other economic evaluations, but challenges Ontario's reimbursement decision.

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.

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.

Sources, Quality, and Reported Outcomes of Superior Capsular Reconstruction: a Systematic Review.

PURPOSE: Superior capsular reconstruction (SCR) has gained attention as a potential treatment option for those with massive irreparable rotator cuff tears without significant arthritis. The aim of this systematic review is to review and evaluate the current sources and quality of SCR literature as well as reported outcomes. METHODS: Three databases (PubMed, Ovid [MEDLINE], and EMBASE) were searched independently and in duplicate to systematically screen the literature. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist guided the reporting and data abstraction. The results are presented in a narrative summary fashion using descriptive statistics. RESULTS: Overall, 58 studies were identified, including 304 different patients. There was a rapid increase in the number of publications observed over the past 3 years, with the most dramatic single-year increase noted from 2017 to 2018 (175% increase). There are no level 1 studies, and 95% of the included studies were level 4 and 5 evidence. Comparing pre-operative to post-operative pooled-weighted mean outcome scores, the American Shoulder and Elbow Surgeons score improved from 44.2 to 84.8, the Visual Analogue Scale from 5.0 to 1.5, and acromiohumeral distance from 6.5 to 8.4 mm, respectively. Range of motion in forward elevation also improved from 111° to 152°. Among studies reporting, the complication rate was 13.4% with a revision surgery rate of 4.3%. CONCLUSION: Over the past 3 years there has been considerable growth in the number of publications of publications related to SCR. Despite a lack of high-quality clinical evidence, preliminary available evidence does suggest promising results both functionally and radiographically. There is a need for future higher-quality research such as large randomized controlled trials to improve our current understanding of the benefits of SCR.

Predictors of persistent postsurgical pain following total knee arthroplasty: A protocol for systematic review and meta-analysis.

Background: Total knee arthroplasty (TKA) is a commonly performed procedure, primarily when knee joints have been damaged by progressive arthritis; however, over 20% of surgical patients develop persistent postsurgical pain (PPSP). We plan to conduct a systematic review and meta-analysis of factors associated with the development of PPSP following TKA. Methods: We will include peer-reviewed cohort or case-control studies that explore, in an adjusted model, factors associated with the development of PPSP after TKA. We will identify eligible studies, in any language, by a systematic search of MEDLINE, EMBASE, CINAHL, AMED, Scopus, SPORTDiscus, and PsycINFO, from inception of each database. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible studies, and extract information from eligible studies. When possible, we will pool estimates of association for all independent variables reported by more than one study and report both an adjusted odds ratio and the absolute risk increase and associated 95% confidence intervals (Cis). We will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to summarize the quality of evidence for all meta-analyses as high, moderate, low, or very low. Discussion: Our results will facilitate identification of patients at risk for the development of PPSP following TKA, highlight promising predictors for further study, and help guide the design of interventional studies to improve prognosis of high-risk patients.

Contexte: L'arthroplastie complète du genou est une intervention communément réalisée, principalement lorsque les articulations des genoux ont été endommagées par l'arthrite dégénérative; toutefois, plus de 20 % des patients ayant été opérés développent de la douleur postopératoire persistante. Nous comptons ffectuer une revue systématique et une méta-analyse des facteurs associés au développement de la douleur postopératoire persistante après une arthroplastie complète du genou.Méthodes: Nous incluerons les études de cohorte ou les études cas-témoins examinées par des pairs qui explorent, dans un modèle ajusté, les facteurs associés au développement de la douleur postopératoire persistante après une arthroplastie complète du genou. Nous recenserons les études admissibles, peu importe la langue dans laquelle elle sont écrites, en faisant une recherche systématique dans MEDLINE, EMBASE, CINAHL, AMED, Scopus, SPORTDiscus et PsycINFO, depuis les tout débuts de chaque base de données. Des paires d'examinateurs passeront en revue les titres et les résumés des citations répertoriées de manière indépendante et en double, puis ils examineront les textes complets des études potentiellement admissibles et en extrairont l'information. Lorsque possible, nous ferons une estimation globale de l'associatio pour toutes les variables indépenantes rapportées par plus d'une étude et rapporterons les rapports de cote ajustés, ainsi que l'augmentation du risque absolu et les IC à 95 % associés. Nous utiliserons l'approche GRADE pour résumer la qualité des données probantes pour toutes les méta-analyses, afin de déterminer si elle est élevée, modérée, faible ou très faible.Discussion: Nos résultats faciliteront le repérage des patients à risque de développer de la douleur postopératoire persistante après une arthroplastie complète du genou, mettront en lumière les prédicteurs prometteurs pour de futures et contribuerot à orienter la conception d'études interventionnelles afin d'améliorer le pronostic des patients à haut risque.

Effectiveness of Valgus Offloading Knee Braces in the Treatment of Medial Compartment Knee Osteoarthritis: A Systematic Review.

CONTEXT:: Knee osteoarthritis affects 9.3 million adults over age 45 years in the United States. There is significant disability associated with this condition. Given the potential complications and the significant cost to the health care system with the dramatic increase in total knee arthroplasties performed for this condition, assessment of the efficacy of nonoperative modalities, such as offloading knee braces, is essential as part of optimizing nonoperative treatment for this condition. OBJECTIVE:: To determine the effectiveness of valgus offloader braces in improving clinical outcomes for patients with medial compartment knee osteoarthritis. DATA SOURCES:: Three databases (PubMed, MEDLINE, and EMBASE) were searched from database inception through July 28, 2017. STUDY SELECTION:: Studies reporting outcomes of valgus offloader knee braces in the treatment of medial compartment knee osteoarthritis were included. STUDY DESIGN:: Systematic review. LEVEL OF EVIDENCE:: Level 4. DATA EXTRACTION:: Data pertaining to demographics, descriptive statistics, and clinical outcomes were extracted from the included studies. The methodological quality of included studies was evaluated. RESULTS:: A total of 31 studies were included, with a total of 619 patients. The majority of studies reported improved pain outcomes using valgus offloader braces. However, variable results were reported as to whether valgus offloader braces significantly improved functional outcomes and stiffness. Offloader bracing was more effective at reducing pain when compared with neutral braces or neoprene sleeves. CONCLUSION:: Valgus offloader bracing is an effective treatment for improving pain secondary to medial compartment knee osteoarthritis. The literature remains unclear on the effectiveness of valgus offloader braces with regard to functional outcomes and stiffness. Larger prospective randomized trials with consistent outcome assessment tools and consideration of patient compliance would be beneficial to more accurately determine treatment effects of valgus offloader bracing.