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Abstract Background Degenerative Cervical Myelopathy is a debilitating condition and current recommendations encourage shared decision-making between surgeons and patients. However, there is limited data on patients’ values and preferences for surgical decision making. This study aimed to quantify and compare the relative importance of neurologic function, risk of future surgery, and complications to patients with cervical stenosis. Methods Patients with cervical stenosis presenting for surgical evaluation, or post-operative cervical decompression patients, were recruited to participate. Demographic information including modified Japanese Orthopedic Association (mJOA) score, type of surgery, and complications were recorded and anonymized to study ID. Patients then completed an online discrete-choice experiment survey. In a series of 10 questions, respondents chose between two hypothetical health states defined in terms of five attributes, or “decision factors”: (i) upper extremity neurologic function, (ii) lower extremity neurologic function, (iii) risk of cervical spine surgery, (iv) dysphagia, and (v) C5 palsy. Participants were asked to choose which ‘life’ they preferred, and a regression model was used to quantify the importance of each decision factor. Results We report three key findings that can aid clinicians in shared decision-making conversations: (i) all patients regard lower extremity neurologic function as the most important decision factor, (ii) dysphagia, a complication, and upper extremity neurologic function are equally important, and (iii) patients who have undergone surgery weigh neurologic function as less important, and complications as more important than patients who have not undergone surgery. Conclusions Patient preferences for management of degenerative cervical myelopathy are influenced by several considerations including the experience of surgery itself. Communication of benefits and harms associated with surgical and conservative care can optimize shared decision making. Further research should be conducted to evaluate for decisional regret and the impact of complications to inform treatment conversations.

Purpose: The objective of this study was to perform a cost-utility analysis comparing open carpal tunnel release (OCTR), endoscopic carpal tunnel release (ECTR), and carpal tunnel release with ultrasound (CTR-US) guidance. The aim of this study was to determine whether one of the three approaches was dominant from a societal perspective in terms of cost-utility, in order to help inform policy and treatment decision making going forward. Methods: This study was performed using a decision tree model, with three potential treatment decisions (OCTR, ECTR, and CTR-US). A cost-utility analysis was performed, using the incremental cost-effectiveness ratio. The willingness-to-pay threshold was set at $50,000/quality-adjusted life year (QALY) as per previous literature. Results: The total payer episode costs for OCTR, ECTR, and CTR-US were $4,324, $4,978, and $3,249, respectively. The cost of time off work for each procedure was $4,376.14, $3,650.24, and $622.20, respectively. The overall QALYs gained from each procedure were 0.42, 0.42, and 0.43, respectively (the maximum possible being 0.5 for a 6-month period). Compared with OCTR, ECTR and CTR-US were both less costly from a societal perspective (−$71.90 and −$4,828.94, respectively) and associated with greater QALYs gained (+0.0004 and +0.0143, respectively). Conclusions: Overall, the key finding of this study is that, from a societal perspective, CTR-US is less costly and provides greater QALY improvement when compared with OCTR and ECTR, and thus, CTR-US is considered a dominant intervention over both OCTR and ECTR. Type of study/level of evidence: Economic and decision analysis; IIb.

Background:. Degenerative cervical myelopathy (DCM) occurs when spondylotic changes compress the spinal cord and cause neurologic dysfunction. Because of a lack of comparative data on nonoperative care versus surgery for DCM, it has been difficult to support patients through the shared decision-making process regarding treatment options. Our objective was to synthesize the best available data in a manner that helps clinicians and patients to weigh the differences between nonoperative care and surgery at different ages and disease severity. The 2 patient-centered questions we sought to answer were (1) “am I more likely to experience worsening myelopathy with nonoperative care, or need more surgery if I have my myelopathy treated operatively?” and (2) “how much better will my quality of life be with nonoperative care versus surgery?” Methods:. We used a health economic technique, microsimulation, to model head-to-head comparisons of nonoperative care versus surgery for DCM. We incorporated the best available data, modeled patients over a lifetime horizon, used direct comparators, and incorporated uncertainty in both natural history and treatment effect. Results:. Patients with mild DCM at baseline who were ≥75 years of age were less likely to neurologically decline under nonoperative care than to undergo a second surgery if the index surgery was an anterior cervical discectomy and fusion (ACDF), cervical disc arthroplasty (ADR), or posterior cervical decompression and instrumented fusion (PDIF). Using quality-adjusted life-years (QALYs), our results suggest that surgery for DCM may be superior to nonoperative care. However, for all patients except those with severe DCM who are of middle age or younger (depending on the procedure, ≤50 to ≤60 years of age), the lower bound of the 95% confidence interval for the estimated difference in QALYs was

Introduction Recurrent shoulder dislocations often cause attrition of the labrum and progressive loss of the anterior bony contour of the glenoid. Treatment options for this pathology involve either soft tissue repair or bony augmentation procedure. The optimal management for patients with shoulder instability with subcritical bone loss remains unknown and current clinical practice is highly varied.Methods and analysis The Shoulder instability Trial comparing Arthroscopic stabilisation Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multicentre, randomised controlled trial of 114 patients diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss (10%–20%, measured on 3D CT using circle of best fit technique). Patients are randomised either arthroscopic capsuloligamentous repair (Bankart repair+remplissage) or open or arthroscopic coracoid transfer (Latarjet procedure). The primary outcome of this trial will be the between-group difference in the change from baseline to 24 months postintervention in Western Ontario Shoulder Instability Index scores. Secondary outcomes include: (1) rates of recurrent shoulder dislocations and symptoms of instability up to 24 months’ postsurgery; (2) clinical outcomes measured by American Shoulder and Elbow Society score, Shoulder Activity Scale, EQ-5D and Patient Satisfaction Scale; (3) physical examination (range of motion, stability); (4) return to previous level of activity/sport; (5) rate of shoulder-related complications and serious adverse events.Ethics and dissemination This protocol has been reviewed and approved by the Hamilton Integrated Research Ethics Board (HiREB; project number 15998) prior to commencement of the trial. Results from the study will be submitted for publication in a peer-reviewed journal regardless of whether there are statistically significant findings.Trial registration number NCT05705479; this study was prospectively registered on clinicaltrials.gov.

Introduction Pilot or feasibility trials examine the feasibility, viability and recruitment potential of larger, main trials. Specifically, a pilot trial can be instrumental in identifying methodological issues essential to the development of an effective research protocol. However, numerous studies published as pilot or feasibility studies have demonstrated notable inconsistencies in the nature of information reported, resulting in poor-quality and incomplete reporting. It is unclear whether such low quality or incompleteness of reporting is also prevalent in arthroplasty pilot trials.Methods and analysis This protocol outlines a methodological survey examining the completeness of reporting among hip and knee arthroplasty pilot trials in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to pilot trials. Secondary objectives include: (1) determining the prevalence of ‘spin’ practices, defined as: (a) placing a focus on statistical significance rather than feasibility, (b) presenting results that show the trial to be non-feasible as feasible or (c) emphasising the effectiveness or potential intervention benefits rather than feasibility; (2) determining factors associated with incomplete reporting, and ‘spin’. A search of PubMed will be conducted for pilot trials in hip or knee arthroplasty published between 01 January 2017 and 31 December 2023. Following screening, appropriate data will be extracted from eligible publications and reported as descriptive statistics, encompassing elements of the CONSORT checklist associated with completeness of reporting. Logistic regression analysis and Poisson regression will be used to analyse factors associated with completeness of reporting and spin.Ethics and dissemination This methodological review does not require formal ethical approval, as it will solely involve the use of published and publicly reported literature. The results of this study will be disseminated through submission to peer-reviewed journals and academic conference presentations. Study details will be sent to McMaster University’s media coordinators to be shared through the institution’s research-focused platforms.

Abstract Background Patients with obesity presenting in need of surgical intervention are at 2-to-sixfold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To mitigate some of these concerns, prescribed preoperative weight loss via very low-energy diets (VLEDs) has become a standard of care for patients with obesity undergoing bariatric surgery. While VLEDs have become standard prior to bariatric surgery, their application in other surgical settings remains limited. A large, definitive trial is required to resolve the uncertainty surrounding their use in these patients. Prior to a definitive trial to compare the efficacy of VLEDs in patients with obesity undergoing major non-bariatric surgery, we require a pilot trial. We argue a pilot trial will provide the following critical feasibility insights: (1) assessment of recruitment ability, (2) evaluation of adherence to VLED regimens, and (3) assessment of our ability follow patients completely. Methods The proposed trial will be a multi-center, surgeon, outcome assessor, and data-analyst blinded, parallel pilot randomized controlled trial (RCT). Patients older than 18 years of age with a body mass index (BMI) of greater than 30 kg/m2 undergoing major elective non-bariatric surgery will be eligible for inclusion. Consecutive patients will be allocated 1:1 according to a computer-generated randomization schedule. Randomization will be stratified by center and will employ randomly permutated blocks. All patients in the intervention group will receive standard patient counseling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize commercially available weight loss products for three weeks preoperatively. The primary outcomes (randomization percentage, recruitment rate, intervention adherence, follow-up completion, network development) will assess feasibility. Descriptive statistics will be used to characterize the study sample. Discussion The PREPARE pilot RCT will aim to provide feasibility and safety data that will allow for the successful completion of the definitive PREPARE trial that has the potential to provide practice changing data pertaining to the regular use of VLEDs as a means of pre-habilitation for patients with obesity undergoing major non-bariatric surgery. Trial registration This study was registered on ClinicalTrials.gov (reference #NCT05918471) on June 23, 2023.

Abstract 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).

Abstract Background Back pain is the leading cause of disability worldwide. Despite guidelines discouraging opioids as first-line treatment, opioids remain the most prescribed drugs for back pain. There is renewed interest in exploring the potential medical applications of cannabis, and with the recent changes in national legislation there is a unique opportunity to investigate the analgesic properties of cannabis. Methods This was a multi-center survey-based study examining patient perceptions regarding cannabis for spine pain. We included patients presenting with back or neck pain to one of three Orthopedic clinics in Ontario. Our primary outcome was perceived effect of cannabis on back pain, while secondary outcomes were perceptions regarding potential applications and barriers to cannabis use. Results 259 patients participated in this study, 35.3% (90/255) stating they used cannabis medically. Average pain severity was 6.5/10 ± 0.3 (95% CI 6.2–6.8). Nearly three-quarters were prescribed opioids (73.6%, 148/201), with oxycodone/oxycontin (45.9% 68/148) being the most common, and almost half of (49.3%, 73/148) had used an opioid in the last week. Patients estimated cannabis could treat 54.3% ± 4.0 (95% CI 50.3–58.3%) of their spine pain and replace 46.2% ± 6. 6 (95% CI 39.6–52.8%) of their current analgesics. Age (β = − 0.3, CI − 0.6–0.0), higher pain severity (β = 0.4, CI 0.1–0.6) and previous cannabis use (β = 14.7, CI 5.1–24.4) were associated with a higher perceived effect of cannabis. Patients thought cannabis would be beneficial to treat pain (129/146, 88.4%), and reduce (116/146, 79.5%) or eliminate opioids (102/146, 69.9%). Not considering using cannabis for medical purposes (65/150, 43.3%) was the number one reported barrier. Conclusions Patients estimated medical cannabis could treat more than half of their spine pain, with one in three patients already using medical cannabis. 79% of patients also believe cannabis could reduce opioid usage. This data will help support more research into cannabis for musculoskeletal pain.

Introduction The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials.Methods and analysis A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items.Ethics and dissemination This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Objective To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery.Design We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants.Participants & setting Surgeons and surgeon trainees in the Department of Surgery at McMaster University.Outcomes The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses.Results 82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24–73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p

IntroductionThe properties of creative products-novelty and usefulness-are generally agreed upon by researchers. Yet, consensus is lacking on which personal and environmental factors contribute to an individual's creative potential, or to what extent. substantial research work has been conducted in this area, leading to the publication of many systematic reviews and meta-analyses collating the available evidence. However, many of these reviews have differing methodological and theoretical characteristics, and often report conflicting results. To summarize the current review literature on factors associated with creativity and better understand the similarities and discrepancies among reviews on the same topic, we plan to conduct an umbrella review of reviews.MethodsThis protocol has been registered in Open Science Framework (DOI: 10.17605/OSF.IO/H78YS). We will search MEDLINE, PsycINFO, Web of Science, EMBASE, and Google Scholar for peer-reviewed reviews exploring factors associated with creativity. The quality of the included reviews will be assessed using the Risk of Bias Assessment Tool for Systematic Reviews (ROBIS), and the degree of study overlap across reviews assessed through calculation of the corrected covered area (CCA). Descriptive analyses will be performed to synthesize the results of the included reviews. We plan to use the results to create a holistic framework of the factors associated with creativity, which could be used to cross-validate existing creativity theories, or create new ones.Ethics and disseminationThe results of this umbrella review will be published in a relevant psychology-focused journal and presented at local, national and international conferences. As all data is peer-reviewed and presented in aggregate, we will not require ethics approval.

Hyperparathyroidism is a common endocrine disorder that occurs secondary to abnormal parathyroid gland functioning. Depending on the type of hyperparathyroidism, surgical extirpation of hyperfunctioning parathyroid glands can be considered for disease cure. Intraoperative parathyroid hormone (IOPTH) monitoring improves outcomes in patients undergoing surgery for primary hyperparathyroidism, but studies are needed to characterize its institutional adoption and its role in surgery for secondary and tertiary hyperparathyroidism, as these entities can be difficult to cure. Hence, we will perform a cross-sectional survey study of surgeon rationale, operational details, and barriers associated with IOPTH monitoring adoption across North America. We will utilize a convenience sampling technique to distribute an online survey to head and neck surgeons and endocrine surgeons across North America. This survey will be distributed via email to three North American professional societies (i.e., Canadian Society for Otolaryngologists-Head and Neck Surgeons, American Head and Neck Society, and American Association of Endocrine Surgeons). The survey will consist of 30 multiple choice questions that are divided into three concepts: (1) participant demographics and training details, (2) details of surgical adjuncts during parathyroidectomy, and (3) barriers to adoption of IOPTH. Descriptive analyses and multiple logistic regression will be used to evaluate the impact of demographic, institutional, and training variables on the use of IOPTH monitoring in surgery for all types of hyperparathyroidism and barriers to IOPTH monitoring adoption. Ethics approval was obtained by the Hamilton Integrated Research Ethics Board (2024-17173-GRA). These findings will characterize surgeon and institutional practices with regards to IOPTH monitoring during parathyroid surgery and will inform future trials aimed to optimize the use of IOPTH monitoring in secondary and tertiary hyperparathyroidism.

ImportanceAdaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical.ObjectiveRandomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials.Evidence reviewWe performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods.FindingsOf the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment.Conclusion and relevanceSurgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

BackgroundPreoperative very low energy diet (VLED) interventions are used routinely in patients undergoing bariatric surgery, a surgical subspecialty that deals almost exclusively with patients with obesity. Yet, their use and study has been limited in non-bariatric abdominal surgery. To investigate the use of VLEDs in non-bariatric surgery, we plan on conducting a randomized controlled trial (RCT). Prior to proceeding, however, we have designed two surveys as important pre-emptive studies aimed at elucidating patient and provider perspectives regarding these interventions.MethodsThe patient survey is a cross-sectional, single-center survey aimed at assessing the safety, adherence, barriers to adherence, and willingness to participate in preoperative optimization protocols with VLEDs prior to undergoing elective non-bariatric intra-abdominal surgery (S1 File). The population of interest is all adult patients with obesity undergoing elective non-bariatric intra-abdominal surgery at St. Joseph's Healthcare Hamilton who were prescribed a course of preoperative VLED. The primary outcomes will be safety and adherence. The target sample size is 35 survey responses. The provider survey is a cross-sectional national survey of practicing surgeons in Canada who perform major non-bariatric abdominal surgery aimed assessing the willingness and ability to prescribe preoperative weight loss interventions amongst practicing Canadian surgeons who perform major non-bariatric abdominal surgery (S2 File). The population of interest is independent practicing surgeons in Canada who perform major non-bariatric abdominal surgery. The primary outcome will be willingness to prescribe preoperative VLED to patients with obesity undergoing major non-bariatric abdominal surgery for both benign and malignant indications. The target sample size is 61 survey responses. Descriptive statistics will be used to characterize the sample populations. To determine variables associated with primary outcomes in the surveys, regression analyses will be performed.DiscussionThese survey data will ultimately inform the design of an RCT evaluating the efficacy of preoperative VLEDs for patients with obesity undergoing major abdominal surgery.

Intraoperative parathyroid hormone (iPTH) monitoring is standard-of-care in the surgical management of hyperparathyroidism. It involves real-time determination of circulating PTH levels to guide parathyroid gland excision. There exists several iPTH monitoring criteria, such as the Miami criteria, and a lack of standardization in the timing of post-parathyroid gland excision samples. We present a protocol of a systematic review and network meta-analysis of diagnostic test accuracy to identify the iPTH criteria and post-gland excision timepoint that best predicts surgical cure in hyperparathyroidism. The database search strategy will be developed in conjunction with a librarian specialist. We will perform a search of Medline (Ovid), EMBASE (Ovid), CINAHL, Cochrane Collaboration, and Web of Science from 1990–present. Studies will be eligible if they include adult patients diagnosed with hyperparathyroidism who undergo parathyroidectomy with iPTH monitoring. We will only include studies that report diagnostic test properties for iPTH criteria and/or post-excision sampling timepoints. All screening, full-text review, data extraction, and critical appraisal will be performed in duplicate. Critical appraisal will be performed using QUADAS-2 instrument. A descriptive analysis will present study and critical appraisal characteristics. We will perform evaluation of between-study heterogeneity using I2 and Cochrane Q and where applicable, we will perform sensitivity analysis. Our network meta-analysis will include Bayesian hierarchical framework with random effects using multiple models. Ethics approval is not required. This proposed systematic review will utilize a novel Bayesian network meta-analysis model to help standardize iPTH monitoring in hyperparathyroidism, thereby optimizing patient outcomes and healthcare expenditures.

Aims: Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA). Methods: This study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis. Results: Of 746 HAs performed in the HEALTH trial, 404 were bipolar prostheses and 342 were unipolar. After propensity score weighting, adequate balance between the bipolar and unipolar groups was obtained as shown by standardized mean differences less than 0.1 for each covariable. A total of 24 months after HA, the total WOMAC score and its subcomponents showed no statistically significant difference between the unipolar and bipolar groups. Similarly, no statistically significant difference was found in the PCS and MCS scores of the SF-12 questionnaire. In participants aged 70 years and younger, no difference was found in any of the functional outcomes. Conclusion: From the results of this study, the use of bipolar HA over unipolar design does not provide superior functional outcomes at 24 months postoperatively. The theoretical advantage of reduced acetabular wear with bipolar designs does not appear to influence functional outcomes in the first two years postoperatively. Cite this article: Bone Jt Open 2023;4(5):370–377.

Aims: To develop prediction models using machine-learning (ML) algorithms for 90-day and one-year mortality prediction in femoral neck fracture (FNF) patients aged 50 years or older based on the Hip fracture Evaluation with Alternatives of Total Hip arthroplasty versus Hemiarthroplasty (HEALTH) and Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trials. Methods: This study included 2,388 patients from the HEALTH and FAITH trials, with 90-day and one-year mortality proportions of 3.0% (71/2,388) and 6.4% (153/2,388), respectively. The mean age was 75.9 years (SD 10.8) and 65.9% of patients (1,574/2,388) were female. The algorithms included patient and injury characteristics. Six algorithms were developed, internally validated and evaluated across discrimination (c-statistic; discriminative ability between those with risk of mortality and those without), calibration (observed outcome compared to the predicted probability), and the Brier score (composite of discrimination and calibration). Results: The developed algorithms distinguished between patients at high and low risk for 90-day and one-year mortality. The penalized logistic regression algorithm had the best performance metrics for both 90-day (c-statistic 0.80, calibration slope 0.95, calibration intercept -0.06, and Brier score 0.039) and one-year (c-statistic 0.76, calibration slope 0.86, calibration intercept -0.20, and Brier score 0.074) mortality prediction in the hold-out set. Conclusion: Using high-quality data, the ML-based prediction models accurately predicted 90-day and one-year mortality in patients aged 50 years or older with a FNF. The final models must be externally validated to assess generalizability to other populations, and prospectively evaluated in the process of shared decision-making. Cite this article: Bone Jt Open 2023;4(3):168–181.

Background: Bariatric endoscopy has emerged for non-surgical treatment of obesity, providing a treatment option for weight loss and associated comorbidities. Outcomes of endoscopic sleeve gastroplasty (ESG) of 12 months have been published by our team and there is a need for longer follow-up period understanding the effects of ESG techniques. Aim: This report emphasises on weight loss pattern in follow-up time points and monitors the post-procedure improvement in comorbidities with minimum 4-year follow-up of patients undergoing ESG at a single academic centre in India. Subjects and Methods: This was a prospective cohort study. All procedures were performed by the same surgeon. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities) underwent ESG for treatment of obesity. Patients were systematically followed yearly after their procedure. Data collected on the primary outcome and secondary outcomes were analysed and presented. Results: 612 patients (69.3% female) with a mean age of 40.70 ± 12.66 years and mean body mass index of 34.30 ± 5.05 kg/m2 underwent ESG. Out of 612 patients, follow-up rates for a 1-2-3 and 4 years were 93.1%, 90.2%, 81.7% and 81.9%, respectively. The mean percentage total body weight loss was 18.19% (95% confidence interval [CI]: 17.72–18.57) and %EWL was 49.30% (95% CI: 48.91–49.68) with 90% of participants-maintaining a percentage of total weight loss of ≥5% and 70% of patients maintaining an EWL of ≥25% at 4 years, respectively. Resolution/improvement of comorbidities was 51.2% cases of T2DM, 65.8% cases of hypertension, 73.6% cases of dyslipidaemia and 89.9% remission were in obstructive sleep apnoea. No patient required an emergency intervention, and there was no mortality or significant morbidity. Conclusions: This study shows acceptable results with ESG at 4 years in our unit. Regular monitoring by a multidisciplinary nurtures weight loss, resolution or improvement of comorbidities and improvement of quality of life with low perioperative complications. There is a need for more reports with this approach to determine the amount and duration of weight loss outcome and medical intervention.

Background and Objectives: Functional outcomes are important for oncology patients undergoing lower extremity reconstruction. The objective of the current study was to describe patient reported function after surgery and identify predictors of postoperative function in musculoskeletal oncology patients undergoing lower extremity endoprosthetic reconstruction. Methods: We performed a cohort study with functional outcome data from the recently completed Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. We utilized the 100-point Toronto Extremity Salvage Score (TESS), which was administered pre-operatively and at 3, 6 and 12 months post-operatively. Higher scores indicate better physical functioning, and the minimally important difference is 11 points. We calculated mean functional scores at each timepoint after surgery and developed a logistic regression model to explore predictors of failure to achieve excellent post-operative function (TESS ≥ 80) at 1 year after surgery. Results: The 555 patients included in our cohort showed important functional improvement from pre-surgery to 1 year post-surgery (mean difference 14.9 points, 95%CI 12.2 to 17.6; p < 0.001) and 64% achieved excellent post-operative function. Our adjusted regression model found that poor (TESS 0–39) pre-operative function (odds ratio [OR] 3.3, 95%CI 1.6 to 6.6); absolute risk [AR] 24%, 95%CI 8% to 41.2%), older age (OR per 10-year increase from age 12, 1.32, 95%CI 1.17, 1.49; AR 4.5%, 95%CI 2.4% to 6.6%), and patients undergoing reconstruction for soft-tissue sarcomas (OR 2.3, 95%CI 1.03 to 5.01; AR 15.3%, 95%CI 0.4% to 34.4%), were associated with higher odds of failing to achieve an excellent functional outcome at 1-year follow-up. Patients undergoing reconstruction for giant cell tumors were more likely to achieve an excellent functional outcome post-operatively (OR 0.40, 95%CI 0.17 to 0.95; AR −9.9%, 95%CI −14.4% to −0.7%). Conclusions: The majority of patients with tumors of the lower extremity undergoing endoprosthetic reconstruction achieved excellent function at 1 year after surgery. Older age, poor pre-operative function, and endoprosthetic reconstruction for soft tissue sarcomas were associated with worse outcomes; reconstruction for giant cell tumors was associated with better post-operative function. Level of Evidence: Therapeutic Level IV.

Abstract Background Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. Methods and design The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. Results The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention’s National Healthcare Safety Network reporting criteria (2017). All participants’ surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

AimsThe aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population.MethodsWe performed a post hoc exploratory analysis of a fitter cohort of patients from the HEALTH trial. Participants were aged over 50 years and had sustained a low-energy displaced femoral neck fracture (FNF). The fittest participant cohort was defined as participants aged 70 years or younger, classified as American Society of Anesthesiologists grade I or II, independent walkers prior to fracture, and living at home prior to fracture. Multilevel models were used to estimate the effect of THA versus HA on functional outcomes. In addition, a sensitivity analysis of the definition of the fittest participant cohort was performed.ResultsThere were 143 patients included in the fittest cohort. Mean age was 66 years (SD 4.5) and 103 were female (72%). No clinically relevant differences were found between the treatment groups in the primary and sensitivity analyses.ConclusionThis analysis found no differences in functional outcomes between HA and THA within two years of displaced low-energy FNF in a subgroup analysis of the fittest HEALTH patients. These findings suggest that very few patients above 50 years of age benefit in a clinically meaningful way from a THA versus a HA early after injury.Cite this article: Bone Jt Open 2022;3(8):611–617.

PurposeTo optimize patients prior to bariatric surgery, very low energy diets (VLEDs) are often employed for 2–4 weeks preoperatively. They are known to result in preoperative weight loss, decrease liver volume, and decrease surgeon-perceived operative difficulty. Their impact on postoperative morbidity has been less extensively studied. We performed a focused systematic review and meta-analysis with the aim of comparing preoperative VLEDs prior to bariatric surgery with controls in terms of overall postoperative morbidity.MethodsMEDLINE, Embase, and CENTRAL were searched from database inception to February 2023. Articles were eligible for inclusion if they were randomized controlled trials (RCTs) comparing postoperative morbidity in adult patients (i.e., over the age of 18) receiving a VLED with liquid formulation to those receiving a non-VLED control prior to elective bariatric surgery. Outcomes included overall 30-day postoperative morbidity and preoperative weight loss. An inverse variance meta-analysis was performed with GRADE assessment of the quality of evidence.ResultsAfter reviewing 2,525 citations, four RCTs with 294 patients receiving preoperative VLEDs with liquid formulation and 294 patients receiving a non-VLED control met inclusion. Patients receiving VLED experienced significantly more preoperative weight loss than patients receiving control (mean difference (MD) 3.38 kg, 95% confidence interval (CI) 1.06–5.70, p = 0.004, I2 = 95%). According to low certainty evidence, there was a non-significant reduction in 30-day postoperative morbidity in patients receiving VLED prior to bariatric surgery (risk ratio (RR) 0.67, 95%CI 0.39–1.17, p = 0.16, I2 = 0%).ConclusionThe impact of preoperative VLEDs on postoperative outcomes following bariatric surgery remains unclear. It is possible that VLEDs may contribute to decreased postoperative morbidity, but further larger prospective trials are required to investigate the signal identified in this study.

Introduction A strong pipeline of creative ideas and individuals is critical if we are to tackle the complex healthcare challenges we will face in the 21st century. The field of creativity is severely underinvestigated in the context of surgery, and it is of interest to explore the level and nature of creativity in surgeons, across various specialties and backgrounds. Identifying the areas of surgery with strong and weak levels of creativity, as well as the predictors of high creativity among surgeons, may aid in the selection and training of future surgeons.Methods and analysis A convenience sample of surgeons from the Department of Surgery and McMaster University will be used for the recruitment of participants. The Abbreviated Torrance Test for Adults, a three-part test of divergent thinking ability, will be administered to measure the level and nature of creativity among surgeons. Descriptive analyses and multiple linear regression models are planned to synthesise the results of the survey and identify predictors of divergent thinking ability among surgeons.Ethics and dissemination Ethics approval from the Hamilton Integrated Research Ethics Board was obtained. No harm is expected due to participation in this study. The results of this survey will be published in a peer-reviewed journal and disseminated through conferences and presentations at the regional, national and international levels.

Aims To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Methods Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. Results After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. Conclusion Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189–195.

Artificial intelligence and machine-learning analytics have gained extensive popularity in recent years due to their clinically relevant applications. A wide range of proof-of-concept studies have demonstrated the ability of these analyses to personalize risk prediction, detect implant specifics from imaging, and monitor and assess patient movement and recovery. Though these applications are exciting and could potentially influence practice, it is imperative to understand when these analyses are indicated and where the data are derived from, prior to investing resources and confidence into the results and conclusions. In this article, we review the current benefits and potential limitations of machine-learning for the orthopaedic surgeon with a specific emphasis on data quality.

Abstract Introduction Anterior dislocations, the most common type of shoulder dislocation, are often complicated by subsequent instability. With recurrent dislocations there often is attrition of the labrum and progressive loss of the anterior bony contour of the glenoid. Treatment options for this pathology involve either soft tissue repair or bony augmentation procedure. The optimal management remains unknown and current clinical practice is highly varied. Methods and analysis The Shoulder instability Trial comparing Arthroscopic stabilization Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multi-centre, pilot randomized controlled trial of 82 patients who have been diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss. Patients are randomized to either soft tissue repair (Bankart + Remplissage) or bony augmentation (Latarjet procedure). The primary outcome for this pilot is to assess trial feasibility and secondary outcomes include recurrent instability as well as functional outcomes up to two years post-operatively. Conclusions This trial will help to identify the optimal treatment for patients with recurrent shoulder instability with a focus on determining which treatment option results in reduced risk of recurrent dislocation and improved patient outcomes. Findings from this trial will guide clinical practice and improve care for patients with shoulder instability. Trial registration This study has been registered on http://www.ClinicalTrials.gov with the following identifier: ClinicalTrials.gov Identifier: NCT03585491, registered 13 July 2018, https://www.clinicaltrials.gov/ct2/show/NCT03585491?term=NCT03585491&draw=2&rank=1 . Ethics and dissemination This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB) (approval #4942). Successful completion will significantly impact the global management of patients with recurrent instability. This trial will develop a network of collaboration for future high-quality trials in shoulder instability.

Background: Bariatric metabolic surgery is evolving as an option for the treatment of type 2 diabetes mellitus (T2DM) in patients with obesity and T2DM, warranting more studies on the efficacy of bariatric metabolic surgery on T2DM. Objective: To determine T2DM remission in patients with obesity and T2DM with up to two years follow-up after bariatric metabolic surgery. Materials and Methods: A retrospective review of prospectively maintained data was undertaken to identify patients who had T2DM and underwent bariatric surgery at a single centre in 2016. Data collected included age, gender, body mass index (BMI), fasting plasma glucose, haemoglobin A1c, hypertension, (HTN), Obstructive sleep apnea (OSA), initial weight and the weight at intervals of 6, 12, and 24 months. Data on the treatment of T2DM before the surgery was also collected. The criteria of the American Diabetes Association were used for the definition of T2DM remission. Only the data on patients in this study who had more than 12 months' follow-up information was analysed. Results: Two hundred and eighty patients with T2DM were identified. 191 patients had more than 12 months' follow-up information. Mean age and BMI were 49.58 ± 10.64 years and 44.03 ± 7.86 kg/m2 respectively. There were 29 patients on insulin, 21 (10.9%) on insulin only and 8 (4.2%) on insulin and oral hypoglycaemic agents (OHA). One hundred and forty-six patients (76.4%) were on OHA, 134 on a single OHA and 12 on more than one OHA. Twenty-six patients (13.6%) were newly diagnosed with T2DM when they came in for bariatric metabolic surgery. One hundred and fifty-six patients (81.7%) achieved complete remission. 14 (7.3%) of these patients used to be on insulin with or without OHA and 142 (74.3%) were patients either on OHA or no OHA. There were 12 (6.4%) patients in partial remission. There was improvement in 23 (12.04%). Eight patients were on insulin but at lower doses and 15 were on a single OHA. The average percentage of total weight loss at 6, 12 and 24 months was 29.7%, 33.9% and 35.6% respectively. Patients with shorter duration of T2DM had higher remission rates as compared to patients with longer duration (r = −0.874, P = 0.001). There was also a significant resolution of HTN (81.8%) and OSA (82.3%) after bariatric metabolic surgery. Conclusion: This study collaborates reports that there is significant remission of T2DM after bariatric metabolic surgery in patients with obesity and T2DM. There is a need for prospective, multi-centre, and long-term studies on bariatric metabolic surgery to treat patients with obesity and T2DM.

Abstract. Objectives:. Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system–level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods:. Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results:. A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions:. Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence:. Prognostic—III.

Abstract. Introduction:. Open fractures represent a major source of morbidity. Surgical site infections (SSIs) after open fractures are associated with a high rate of reoperations and hospitalizations, which are associated with a lower health-related quality of life. Early antibiotic delivery, typically chosen through an assessment of the size and contamination of the wound, has been shown to be an effective technique to reduce the risk of SSI in open fractures. The Gustilo-Anderson classification (GAC) was devised as a grading system of open fractures after a complete operative debridement of the wound had been undertaken but is commonly used preoperatively to help with the choice of initial antibiotics. Incorrect preoperative GAC, leading to less aggressive initial management, may influence the risk of SSI after open fracture. The objectives of this study were to determine (1) how often the GAC changed from the initial to definitive grading, (2) the injury and patient characteristics associated with increases and decreases of the GAC, and (3) whether a change in GAC was associated with an increased risk of SSI. Methods:. Using data from the FLOW trial, a large multicenter randomized study, we used descriptive statistics to quantify how frequently the GAC changed from the initial to definitive grading. We used regression models to determine which injury and patient characteristics were associated with increases and decreases in GAC and whether a change in GAC was associated with SSI. Results:. Of the 2420 participants included, 305 participants had their preoperative GAC change (12.6%). The factors associated with upgrading the GAC (from preoperative score to the definitive assessment) included fracture sites other than the tibia, bone loss at presentation, width of wound, length of wound, and skin loss at presentation. However, initial misclassification of type III fractures as type II fractures was not associated with an increased risk of SSI (P = 0.14). Conclusions:. When treating patients with open fracture wounds, surgeons should consider that 12% of all injuries may initially be misclassified when using the GAC, particularly fractures that have bone loss at presentation or those located in sites different than the tibia. However, even in misclassified fractures, it did not seem to increase the risk of SSI.

ObjectiveThe aim of this systematic review and meta-analysis is to evaluate whether the implementation of Enhanced Recovery After Surgery (ERAS) protocols for adult patients undergoing emergency intra-abdominal surgery decreases postoperative length of stay, postoperative morbidity, and mortality compared to conventional perioperative care.MethodsA systematic review and meta-analysis will be performed and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). It has been registered on the International Prospective Register for Systematic Reviews (PROSPERO; CRD42023391709). A comprehensive, electronic search strategy will be used to identify studies published and indexed in MEDLINE, EMBASE, Web of Science, CENTRAL, and Pubmed databases since their inception. Trial registries and references of included studies and pertinent previous systematic reviews will also be searched. Studies will be included if they are randomized controlled trials or cohort studies evaluating adult patients undergoing emergency intra-abdominal surgery and comparing ERAS or modified ERAS protocols to conventional perioperative care and report one of the following outcomes: postoperative length of stay, overall 30-day morbidity, 30-day mortality, 30-day infectious morbidity, prolonged postoperative ileus, return of bowel function, and 30-day readmissions. A meta-analysis will be performed using a random effects model for all comparative data using Cochrane Review Manager 5.3 (London, United Kingdom).DiscussionERAS protocols have become standard of care for patients undergoing elective surgery. Their use in the setting of emergency surgery is far less common. The aim of this systematic review and meta-analysis is to assess whether there are benefits in patient important outcomes with the implementation of ERAS protocols for patients undergoing emergency intra-abdominal surgery. Ultimately, we hope to promote their use and further large randomized controlled trials evaluating emergency surgery ERAS programs.Prospero registration numberCRD42023391709.

Fracture related infections (FRIs) are a disabling condition causing significant concern within the orthopaedic community. FRIs have a huge societal and economic burden leading to prolonged recovery times and the potential for becoming chronic conditions or being life-threatening. Despite its importance in our field, the surgical community has just recently agreed on a definition which, added to the lack of surgical trials assessing preventive and treatment interventions have limited our understanding and precipitated wide variations in surgeons’ practice. This article aims to review the current practices that can be supported with high-quality evidence. Currently, we have a limited body of high-quality evidence on FRI prevention and treatment. A handful of measures have proven effective, such as the use of prophylactic antibiotics, the use of saline and low pressure as the preferred irrigation solution and the safety of delaying initial surgical débridement more than 6 hours without impacting infection rates for open fracture wounds débridement. Future multicentre trials, properly powered, will shed light on current areas of controversy regarding the benefit of different preoperative and perioperative factors for the prevention and treatment of FRIs. Higher quality evidence is needed to guide surgeons to offer an evidence-based approach to prevent FRI occurrence and to treat patients suffering from them.

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Abstract Background Non-union occurs in approximately 5 to 10% of fracture patients, with certain bones at greater risk of failing to heal. Non-unions have a significant impact on socioeconomic costs and the patients short and long-term quality of life. Low intensity pulsed ultrasound (LIPUS) is a non-invasive therapy for non-union treatment that can improve the long-term outcome. The purpose of this study is to summarize the available literature assessing LIPUS potential to improve the union rate in instrumented, infected, and fragility non-unions. Methods A literature search was conducted in the MEDLINE, EMBASE, and CINAHL databases for all relevant literature on the healing rates of LIPUS utilized in instrumented, infected, and fragility non-unions. Study characteristics were summarized for each of the included studies. The percentage of healed patients (healing rate), for instrumented, infected, and fragility fracture non-union patients were pooled from each included study. Results The literature search identified a total of 326 articles, while searching reference lists and grey literature identified an additional 3 articles. There was a total of 29 articles included in this review, with 20 articles included within the quantitative synthesis of healing rates. The most common design of included studies was case series (17 articles), followed by case reports (9 articles). Studies were primarily retrospective (18 studies), with an additional 10 prospective studies. Non-union healing rates were 82% (95% CI: 76 to 87%) in instrumented, 82% (95% CI: 70 to 95%) in infected, and 91% (95% CI: 87 to 95%) in fragility fracture patients with non-unions. Conclusion This study has provided a thorough overview of the current literature on LIPUS treatment for instrumented, infected, and fragility fracture non-unions. The healing rates for non-unions in these subgroups were comparable to healing rates observed with LIPUS use in general non-union literature. LIPUS treatment should be considered as a conservative non-surgical treatment option to potentially reduce the socioeconomic impact and improve the quality of life of these unfortunate patients. Level of evidence 4 (systematic review of primarily case series data)

Abstract Background Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. Methods Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. Results All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. Conclusions These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. Trial registration ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.

Aims: Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery. Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL. Results: For patient and surgical factors, only pre-injury quality of life and isolated fracture showed a statistical effect on all four HRQoL outcomes, while high-energy injury mechanism, smoking, and race or ethnicity, demonstrated statistical significance for three of the four HRQoL outcomes. Patients who did not require reoperation in response to infection, the need for bone grafts, and/or the need for implant exchanges had statistically superior HRQoL outcomes than those who did require intervention within one year after initial tibial fracture nailing. Conclusion: We identified several baseline patient factors, surgical factors, and post-intervention procedures within one year after intramedullary nailing of a tibial shaft fracture that may influence a patient’s HRQoL.

Background: Complications after bariatric surgery are not uncommon occurrences that influence the choice of operations both by patients and by surgeons. Complications may be classified as intra-operative, early (

PurposeThe World Health Organization (WHO) declared severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a pandemic in March 2020, causing almost 3.5 million coronavirus disease (COVID-19) related deaths worldwide. The COVID-19 pandemic has imposed a significant burden on healthcare systems, economies, and social systems in many countries around the world. The access and delivery of rehabilitation care were severely disrupted, and patients have faced several challenges during the COVID-19 outbreak. These challenges include addressing new functional impairments faced by survivors of COVID-19 and infection prevention to avoid the virus spread to healthcare workers and other patients not infected with COVID-19. In this scoping review, we aim to develop rehabilitation recommendations during the COVID-19 pandemic across the continuum of rehabilitation care.Materials and MethodsEstablished frameworks were used to guide the scoping review methodology. Medline, Embase, Pubmed, CINAHL databases from inception to August 1, 2020, and prominent rehabilitation organizations’ websites were searched.Study SelectionWe included articles and reports if they were focused on rehabilitation recommendations for COVID-19 survivors or the general population at the time of the COVID-19 pandemic.Data ExtractionTwo of our team members used the pre-tested data extraction form to extract data from included full-text articles. The strength and the quality of the extracted recommendations were evaluated by two reviewers using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach.ResultsWe retrieved 6,468 citations, of which 2,086 were eligible after removing duplicates. We excluded 1,980 citations based on the title and the abstract. Of the screened full-text articles, we included 106 studies. We present recommendations based on the patient journey at the time of the pandemic. We assessed the evidence to be of overall fair quality and strong for the recommendations.ConclusionWe have combined the latest research results and accumulated expert opinions on rehabilitation to develop acute and post-acute rehabilitation recommendations in response to the global COVID-19 pandemic. Further updates are warranted in order to incorporate the emerging evidence into rehabilitation guidelines.

Abstract Background In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. Methods The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. Results We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. Conclusions The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. Trial registration Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Purpose: Metacarpal neck fractures may perform well without operative intervention, but the current literature on this topic is fragmented and guidance on managing these injuries needs further refinement. We conducted a systematic review and network meta-analysis to provide a comprehensive evaluation of the various treatments available for these injuries. Methods: We searched 3 electronic databases and included any study comparing interventions for metacarpal neck fractures. We conducted a Bayesian network meta-analysis for each outcome. Results: We identified a total of 14 studies comparing: antegrade (AIMP) or retrograde (RIMP) intramedullary pinning, buddy strapping, transverse pinning (TP), functional bracing, plating, retrograde cross-pinning, a combination of retrograde cross-pinning and plating, and placement of an orthosis or casting. Although the results were not statistically significant, the effect estimates suggested more favorable pain reduction and functional improvement with AIMP compared with nonsurgical therapies and RIMP in the short term (3 months or less). However, differences between interventions at later follow-up were less extreme; data on short-term pain and function with surgical options outside AIMP and RIMP were unavailable. In addition, compared with both plating and TP, AIMP was associated with significantly higher risks for implant migration and neurological events. There were contrasting findings in union-related outcomes. Plating showed the earliest time to union (not statistically significant) but TP demonstrated the lowest risk for a delayed union. Conclusions: This review demonstrated that although AIMP may be a viable surgical option for early symptomatic relief after a metacarpal neck fracture, it may also be associated with a greater likelihood of certain postoperative complications. Clinicians should consider patient preferences for the time frame of symptomatic relief when selecting the optimal treatment, and patients should weigh the advantages and disadvantages of each available option, especially when considering invasive surgery. Considering the lack of high-quality primary research investigating these interventions, future studies are needed to make more definitive conclusions. Type of study/level of evidence: Therapeutic II.

Background: The majority of clavicle fractures are midshaft injuries, although fractures of the distal or medial fragment also occur. The aim of this study was to review the current evidence on these injuries to help inform future treatment plans. Methods: We searched for studies comparing interventions for medial, midshaft, or distal clavicle fractures; however, we did not identify any comparative studies on medial fractures and performed a secondary search on this topic. We conducted Bayesian network meta-analyses, although this was not feasible with studies on medial fractures and we described their results qualitatively. Results: For midshaft fractures, we found statistically significant improvements in function and time to radiographic union with plating, an elastic stable intramedullary nail (ESIN), and the Sonoma CRx intramedullary nail over nonoperative treatments. Both plating and an ESIN also showed significantly lower risks of nonunion and malunion relative to nonoperative methods. For distal fractures, a locking plate (LP) with or without coracoclavicular (CC) suturing yielded significantly better outcomes over K-wires with or without tension bands, CC suturing alone, an LP with a CC screw, a hook plate, and a sling. For medial fractures, plating may result in more favorable functional and union-related outcomes, although implant irritation may occur. In addition, K-wires, tension bands, and a screw with sutures demonstrated success when plating was technically not feasible in a few cases, whereas treatment with a sling may result in reduced function and a higher risk of complications relative to surgery. Conclusion: This study can provide guidance on the management of medial, midshaft, and distal clavicle fractures. The current evidence suggests that plating, an ESIN, and a CRx intramedullary nail are all good options for midshaft fractures; an LP with or without CC suturing should be preferred for distal fractures; and plating is also acceptable for medial fractures, provided that the patient is deemed suitable for surgery and has the adequate bone stock and sufficiently sized medial fragment necessary to implant the device. Patient preferences for certain outcomes should be considered, which may result in different treatment recommendations.

Background: Numerous fixed-stem implants exist for radial head arthroplasty; therefore, we conducted a systematic review to compare the safety and efficacy of different types of fixed-stem implants. Methods: We conducted a literature search, updated from a previous systematic review, to identify studies evaluating a fixed-stem radial head arthroplasty implant for any indication. We extracted data on revision rates, specific complications, and functional scores. We pooled results across studies using a random-effects method, using proportions for dichotomous data and mean values for functional scores. We analyzed outcomes by indication and specific implant. Results: We included 31 studies. Studies included patients with radial head fractures only, terrible-triad injuries, or Essex-Lopresti injuries or included a heterogeneous population. We identified 15 different fixed-stem implants. The results of our analysis revealed that patients with terrible-triad injuries may be at an increased risk of revision and instability and patients with Essex-Lopresti injuries may be at an increased risk of arthritis, capitellar erosion, and osteolysis. After removing these outliers and pooling the results by specific device, we observed variability across devices in the rates of revision, arthritis, capitellar erosion, instability, and osteolysis, as well as in functional scores. Conclusion: Differences were seen across different implants in revision rates, certain complications, and functional scores. This study highlighted that these devices should be evaluated within the context of the patient population under examination, as patients with Essex-Lopresti or terrible-triad injuries may demonstrate worse outcomes relative to those with a fracture only.

Background:. The prevalence of gender-based and sexual harassment in the field of orthopaedic surgery in Canada is high. Previous research in other jurisdictions has identified the most common perpetrators of harassment to be senior surgeons or directors. We aimed to identify the most frequent perpetrators of gender-based and sexual harassment in orthopaedic surgery in Canada. Methods:. We conducted a Canada-wide survey of all orthopaedic surgeons registered with the Canadian Orthopaedic Association and the Canadian Orthopaedic Residents’ Association. The development of our 116-item questionnaire was informed by a review of the literature and other published gender-based and sexual harassment surveys. Descriptive analyses, including frequency counts with associated 95% confidence intervals (CIs), are reported for all data. Results:. Of the 465 survey respondents, the median age was 43 years (interquartile range, 35 to 59) and respondents were most commonly male (72%), White (81%), married (77%), and staff orthopaedic surgeons (68%). Peers were identified as the most common perpetrators of gender-based harassment (55%, 95% CI, 50 to 59), and patients were identified as the most common perpetrators of sexual harassment (48%, 95% CI, 43 to 52). Women were more likely to report direct supervisors or patients as the perpetrators of gender-based and sexual harassment, and men reported peers as the most common perpetrators. Conclusion:. Orthopaedic surgery peers and patients are the most commonly reported perpetrators of gender-based and sexual harassment in Canada. The results of this study may be helpful to institutions in designing and focusing educational programs and/or policies and procedures to help reduce harassment incidents in the training and work environment.

Purpose: The coronavirus disease-19 (COVID-19) was declared a pandemic by the World Health Organization in March 2020. COVID-19, caused by SARS-CoV-2 has imposed a significant burden on health care systems, economies, and social systems in many countries around the world. The provision of rehabilitation services for persons with active COVID-19 infection poses challenges to maintaining a safe environment for patients and treating providers.Materials and Methods: Established frameworks were used to guide the scoping review methodology. Medline, Embase, Pubmed, CINAHL databases from inception to August 1, 2020, and prominent rehabilitation organizations’ websites were searched.Study Selection: We included articles and reports if they were focused on rehabilitation related recommendations for COVID-19 patients, treating providers, or the general population.Data Extraction: Pairs of team members used a pre-tested data abstraction form to extract data from included full-text articles. The strength and the quality of the extracted recommendations were evaluated by two reviewers using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.Results: We retrieved 6,468 citations, of which 2,086 were eligible for review, after duplicates were removed. We excluded 1,980 citations based on title and abstract screening. Of the screened full-text articles, we included all 106 studies. A summary of recommendations is presented. We assessed the overall evidence to be strong and of fair quality.Conclusion: The rehabilitation setting, and processes, logistics, and patient and healthcare provider precaution recommendations identified aim to reduce the spread of SARS-CoV-2 infection and ensure adequate and safe rehabilitation services, whether face-to-face or through teleservices. The COVID-19 pandemic is rapidly changing. Further updates will be needed over time in order to incorporate emerging best evidence into rehabilitation guidelines.

Objective To assess the efficacy and harms of adding medical cannabis to prescription opioids among people living with chronic pain.Design Systematic review.Data sources CENTRAL, EMBASE and MEDLINE.Main outcomes and measures Opioid dose reduction, pain relief, sleep disturbance, physical and emotional functioning and adverse events.Study selection criteria and methods We included studies that enrolled patients with chronic pain receiving prescription opioids and explored the impact of adding medical cannabis. We used Grading of Recommendations Assessment, Development and Evaluation to assess the certainty of evidence for each outcome.Results Eligible studies included five randomised trials (all enrolling chronic cancer-pain patients) and 12 observational studies. All randomised trials instructed participants to maintain their opioid dose, which resulted in a very low certainty evidence that adding cannabis has little or no impact on opioid use (weighted mean difference (WMD) −3.4 milligram morphine equivalent (MME); 95% CI (CI) −12.7 to 5.8). Randomised trials provided high certainty evidence that cannabis addition had little or no effect on pain relief (WMD −0.18 cm; 95% CI −0.38 to 0.02; on a 10 cm Visual Analogue Scale (VAS) for pain) or sleep disturbance (WMD −0.22 cm; 95% CI −0.4 to −0.06; on a 10 cm VAS for sleep disturbance; minimally important difference is 1 cm) among chronic cancer pain patients. Addition of cannabis likely increases nausea (relative risk (RR) 1.43; 95% CI 1.04 to 1.96; risk difference (RD) 4%, 95% CI 0% to 7%) and vomiting (RR 1.5; 95% CI 1.01 to 2.24; RD 3%; 95% CI 0% to 6%) (both moderate certainty) and may have no effect on constipation (RR 0.85; 95% CI 0.54 to 1.35; RD −1%; 95% CI −4% to 2%) (low certainty). Eight observational studies provided very low certainty evidence that adding cannabis reduced opioid use (WMD −22.5 MME; 95% CI −43.06 to −1.97).Conclusion Opioid-sparing effects of medical cannabis for chronic pain remain uncertain due to very low certainty evidence.PROSPERO registration numberCRD42018091098.

Abstract Background Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18–60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations. Trial registration The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Abstract Background There is an increasing number of interventions aimed at reducing the incidence and improving the identification and management of intimate partner violence (IPV), which are being tested in randomized clinical trials. Publication bias, improper reporting, and selective reporting in clinical trials have led to widespread adoption of pre-registration of clinical trials. Non-publication of study results leads to inefficiency, ethical issues, and scientific issues with the IPV literature. When study results and methodology are not made available through publication or other public means, the results cannot be used to their full potential. The objective of this study was to determine the publication rates of IPV trials registered in a large clinical trial registry. Methods We conducted a systematic review of all IPV-related clinicaltrials.gov records and determined whether the studies that had been completed for ≥ 18 months have been published in a peer-reviewed journal or in the clinicaltrials.gov registry. Two authors extensively searched the literature and contacted study investigators to locate full-text publications for each included study. Results Of 83 completed IPV-related trials registered on clinicaltrials.gov, 64 (77.1%, 95% CI: 66.6–85.6) were subsequently published in full-text form. Of the 19 unpublished studies, authors confirmed that there was no publication for 11 studies; we were unable to contact the investigator or locate a publication for the remaining eight studies. Only four studies (all published) posted their results on clinicaltrials.gov upon completion. Conclusion Approximately one in four IPV trials are not published 18 months after completion, indicating that clinicians, researchers, and other evidence users should consider whether publication bias might affect their interpretation of the IPV literature. Further research is warranted to understand reasons for non-publication of IPV research and methods to improve publication rates.

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.