Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

INTRODUCTION: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation. METHODS AND ANALYSIS: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022. TRIAL REGISTRATION NUMBER: ISRCTN11499185.

Construct validation of a novel synthetic tendon model used for assessing surgeon performance in a simulated core suture tendon repair technique.

BACKGROUND: The strength of tendon repair is dependent on the quality of the core suture. Organic and synthetic materials have been used to simulate tendon repair for training; however, no model has undergone construct validation. OBJECTIVES: To determine the construct validity of a novel synthetic tendon repair model. METHODS: Synthetic silicone tendon models were used to simulate adult Achilles tendon (AT) and digital flexor tendon (FT). Participants were categorised into novice, intermediate, and advanced groups based on prior surgical experience. Participants repaired tendons using the modified Kessler technique. A validated motion analysis system was used to measure the duration, path length, and movement count during the simulated task. A global rating score was also used to assess the performance. RESULTS: All participants in the novice (n = 12), intermediate (n = 8) and advanced (n = 11) groups completed the tasks. The results (mean±standard deviation) were duration (872 ± 335, 492 ± 257 and 357 ± 40 s), path length (9493 ± 3173, 6668 ± 1740 and 4672 ± 1228 cm), movement count (4974 ± 673, 4228 ± 259 and 3962 ± 69) and global rating (39 ± 13, 61 ± 14, 81 ± 5), respectively. The Kruskal-Wallis test was significant for all outcome measures (p < 0.01). Significant differences in duration and movement count were identified post-hoc in the AT model for each experience group (p < 0.05), and between novice and intermediate participants for FT repair (p < 0.04). Global rating was significantly different between all groups and was highly correlated with motion metrics (p < 0.01). CONCLUSION: The results support construct validity of this novel simulated tendon repair model. The global rating scores may allow wide utility of this simulation. This model provides a valid and safe environment for surgical trainees to practice tendon repair with several cost, ethical and logistical benefits over animal tendon use. 248/250.

Lower urinary tract symptoms in men: the TRIUMPH cluster RCT.

Background: Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective: The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design: This was a two-arm cluster randomised controlled trial. Setting: The trial was set in 30 NHS general practice sites in England. Participants: Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions: Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons' patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures: The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results: A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of -1.81 points, 95% confidence interval -2.66 to -0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of -£29.99, 95% confidence interval -£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval -0.011 to 0.014). Conclusions: The intervention showed a small, sustained benefit for men's lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration: This trial is registered as ISRCTN11669964. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.

Urinary problems among men become more common with age. Nearly one-third of all men aged > 65 years experience some urinary symptoms, which can have a substantial effect on their daily lives. Symptoms include needing to pass urine more often, urgently or during the night, and difficulties in passing urine. Men are usually diagnosed and treated by their general practitioner, and should be offered advice on controlling their symptoms themselves (e.g. lifestyle changes and exercises) before trying tablets or surgery. However, it is not known how helpful such advice is, and how general practices can effectively provide it. Thirty general practices in the West of England and Wessex took part in the study. Practices were split into two groups, with each practice providing either the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions care package or the practice's usual care to all of its patients in the trial. The TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package included a booklet of advice to help control urinary symptoms, with a nurse or healthcare assistant directing men to relevant sections according to their symptoms, and providing follow-up contacts. We mainly assessed the benefits of the TReatIng Urinary symptoms in Men in Primary Healthcare using nonpharmacological and non-surgical interventions care package, compared with usual care, by using a questionnaire on urinary symptoms completed by participants. A total of 1077 men with urinary symptoms that bothered them joined the study. The main result was that men reported greater improvement in urinary symptoms with the TRIUMPH care package than with usual care, 12 months after joining the study. We also found that men receiving the TRIUMPH care package had a slight improvement in quality of life and outlook on their urinary symptoms. There was no difference between the two groups in the number of patients referred to hospital for treatment, the type, number and severity of side effects or cost to the NHS. Overall, the TRIUMPH care package was more effective in treating men with urinary symptoms than usual care by their general practice.

A single cell atlas of frozen shoulder capsule identifies features associated with inflammatory fibrosis resolution.

Frozen shoulder is a spontaneously self-resolving chronic inflammatory fibrotic human disease, which distinguishes the condition from most fibrotic diseases that are progressive and irreversible. Using single-cell analysis, we identify pro-inflammatory MERTKlowCD48+ macrophages and MERTK + LYVE1 + MRC1+ macrophages enriched for negative regulators of inflammation which co-exist in frozen shoulder capsule tissues. Micro-cultures of patient-derived cells identify integrin-mediated cell-matrix interactions between MERTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts, suggesting that matrix remodelling plays a role in frozen shoulder resolution. Cross-tissue analysis reveals a shared gene expression cassette between shoulder capsule MERTK+ macrophages and a respective population enriched in synovial tissues of rheumatoid arthritis patients in disease remission, supporting the concept that MERTK+ macrophages mediate resolution of inflammation and fibrosis. Single-cell transcriptomic profiling and spatial analysis of human foetal shoulder tissues identify MERTK + LYVE1 + MRC1+ macrophages and DKK3+ and POSTN+ fibroblast populations analogous to those in frozen shoulder, suggesting that the template to resolve fibrosis is established during shoulder development. Crosstalk between MerTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts could facilitate resolution of frozen shoulder, providing a basis for potential therapeutic resolution of persistent fibrotic diseases.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

OBJECTIVES: To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon. SETTING: Thirty NHS general practice sites in England. PARTICIPANTS: 1077 men aged 18 or older identified in primary care with bothersome LUTS. INTERVENTIONS: A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites. MEASURES: Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated. RESULTS: 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold. CONCLUSIONS: Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost. TRIAL REGISTRATION NUMBER: ISRCTN11669964.

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

OBJECTIVE: To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. DESIGN: Cluster randomised controlled trial. SETTING: 30 National Health Service general practice sites in England. PARTICIPANTS: Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites). INTERVENTION: Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. MAIN OUTCOME MEASURES: The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores. RESULTS: Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference -1.81 points, 95% confidence interval -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. CONCLUSIONS: A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of -1.81 points (95% confidence interval -0.95 to -2.66) on the IPSS was less than the predefined target reduction of 2.0 points. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11669964.

Follow up after surgery for colorectal liver metastases: A systematic review.

INTRODUCTION: Recurrence post hepatectomy for colorectal liver metastases (CRLM) occurs in 70 % of patients within two years. No established guidance on the method or intensity of follow-up currently exists. The aim of this systematic review was to summarise literature and determine whether it is possible to identify an optimal follow up regime. To this date there are no randomised prospective studies investigating this. METHODS: A systematic review was performed according to PRISMA guidelines. Outcomes included general demographics, method, frequency and duration of follow up, survival and recurrence data. Quality assessment of the papers was performed. RESULTS: Twenty-five articles published between 1994 and 2022 were included, including 9945 patients. CT was the most common imaging modality (n = 14) and CEA most common blood test (n = 11). Intensity of follow up was higher in the first two years post resection and only two papers continued follow up post 5 years resection. There was wide variation in outcome measures - Overall survival (OS) was most commonly reported. Nine papers reported OS ranging between 39 and 78.1 %. CONCLUSIONS: There is wide variation in follow up methods and outcome reporting. There is no strong evidence to support intensive follow up, and the benefits of long term follow up are also unknown due to the lack of patient centred data. High quality, prospective studies should be the focus of future research as further retrospective data is unlikely to resolve uncertainties around optimal follow up.

Shoulder replacement surgery's rising demand, inequality of provision, and variation in outcomes: cohort study using Hospital Episode Statistics for England.

BACKGROUND: The aim of this study was to forecast future patient demand for shoulder replacement surgery in England and investigate any geographic and socioeconomic inequalities in service provision and patient outcomes. METHODS: For this cohort study, all elective shoulder replacements carried out by NHS hospitals and NHS-funded care in England from 1999 to 2020 were identified using Hospital Episode Statistics data. Eligible patients were aged 18 years and older. Shoulder replacements for malignancy or acute trauma were excluded. Population estimates and projections were obtained from the Office for National Statistics. Standardised incidence rates and the risks of serious adverse events (SAEs) and revision surgery were calculated and stratified by geographical region, socioeconomic deprivation, sex, and age band. Hospital costs for each admission were calculated using Healthcare Resource Group codes and NHS Reference Costs based on the National Reimbursement System. Projected rates and hospital costs were predicted until the year 2050 for two scenarios of future growth. RESULTS: A total of 77,613 elective primary and 5847 revision shoulder replacements were available for analysis. Between 1999 and 2020, the standardised incidence of primary shoulder replacements in England quadrupled from 2.6 to 10.4 per 100,000 population, increasing predominantly in patients aged over 65 years. As many as 1 in 6 patients needed to travel to a different region for their surgery indicating inequality of service provision. A temporal increase in SAEs was observed: the 30-day risk increased from 1.3 to 4.8% and the 90-day risk increased from 2.4 to 6.0%. Patients from the more deprived socioeconomic groups appeared to have a higher risk of SAEs and revision surgery. Shoulder replacements are forecast to increase by up to 234% by 2050 in England, reaching 20,912 procedures per year with an associated annual cost to hospitals of £235 million. CONCLUSIONS: This study reports a rising incidence of shoulder replacements, regional disparities in service provision, and an overall increasing risk of SAEs, especially in more deprived socioeconomic groups. These findings highlight the need for better healthcare planning to match local population demand, while more research is needed to understand and prevent the increase observed in SAEs.

Association between surgeon volume and patient outcomes after elective shoulder replacement surgery using data from the National Joint Registry and Hospital Episode Statistics for England: population based cohort study.

OBJECTIVE: To investigate the association between surgeon volume and patient outcomes after elective shoulder replacement surgery to improve patient outcomes and inform future resource planning for joint replacement surgery. DESIGN: Prospective cohort study. SETTING: Public and private hospitals in the United Kingdom, 2012-20. PARTICIPANTS: Adults aged 18 years or older who had shoulder replacement surgery, identified in the National Joint Registry, with linkage of participants in England to Hospital Episode Statistics data. MAIN OUTCOME MEASURES: The main outcome measure was revision surgery. Secondary outcome measures were reoperation within 12 months, serious adverse events, and prolonged hospital stay (>3 nights) after shoulder replacement surgery. RESULTS: 39 281 shoulder replacement procedures undertaken by 638 consultant surgeons at 416 surgical units met the inclusion criteria and were available for analysis. Multilevel mixed effects models and restricted cubic splines were fit to examine the association between a surgeon's mean annual volume and risk of adverse patient outcomes, with a minimum volume threshold of 10.4 procedures yearly identified. Below this threshold the risk of revision surgery was significantly increased, as much as twice that of surgeons with the lowest risk (hazard ratio 1.94, 95% confidence interval 1.27 to 2.97). A greater mean annual surgical volume was also associated with a significantly lower risk of reoperations, fewer serious adverse events, and shorter hospital stay, with no thresholds identified. Annual variation in surgeon volume was not associated with any of the outcomes assessed. CONCLUSIONS: In the healthcare system represented by these registry data, an association was found between surgeons who averaged more than 10.4 shoulder replacements yearly and lower rates of revision surgery and reoperation, lower risk of serious adverse events, and shorter hospital stays. These findings should inform resource planning for surgical services and joint replacement surgery waiting lists and improve patient outcomes after shoulder replacement surgery.

Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.

BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

Key performance and training parameters in primary total hip arthroplasty - an expert consensus using the Delphi technique.

AIMS: Primary total hip arthroplasty (THA) is a commonly performed and successful operation which orthopaedic trainees must demonstrate competence in prior to completion of surgical training. An assessment of agreement between surgical trainers regarding the critical steps of a primary THA has never been undertaken. The aim of this study was to define and rank the key steps of a primary THA regards ease of teaching and their importance in achieving the best patient outcome. MATERIALS AND METHODS: The Delphi technique with 3 iterative rounds was used to establish expert group consensus. The benchmark for consensus was set at an 80% agreement in any category for each step of a THR. The intra-class correlation coefficient (ICC) was used to report on the inter- and intra-rater reliabilities between and within participants responses respectively in rounds 2 and 3. RESULTS: 50 consultant orthopaedic hip surgeons completed round 2, and 28 completed round 3. Overall, 27 steps (54 parameters) were identified, with 16 parameters achieving consensus agreement for their impact on patient outcome, and 17 for ease of teaching. The inter-rater ICC for patient outcome parameters was 0.89 and 0.92 in rounds 2 and 3 respectively while for teaching parameters it was 0.82 and 0.73. 50% of surgeons agreed that acetabular reaming, assessing and accurately restoring leg length, and acetabular cup anteversion were the 3 most difficult steps to teach trainees, while 90% agreed these 3 steps were substantially important to patient outcome. Another 5 steps achieved consensus for their substantial impact on patient outcome but failed to achieve consensus for ease of teaching. CONCLUSIONS: The results of this expert consensus have produced a rank-order list of the key steps in primary THA, which may be used for orthopaedic curriculum development and guiding focused improvements for surgical training in primary THR including simulation.

Mapping the Oxford Shoulder Score onto the EQ-5D utility index.

PURPOSE: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS. METHODS: 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing samples. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training sample. These were internally validated, and their performance evaluated on the testing sample. Model performance was evaluated over 100-fold repeated training-testing sample splits. RESULTS: For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241-0.0278) while the SUR models had the lowest MAE (0.105-0.113). CONCLUSION: The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome.

Validating the accuracy of a novel virtual reality platform for determining implant orientation in simulated primary total hip replacement.

Introduction: Accurate acetabular cup and femoral stem component orientation are critical for optimising patient outcomes, reducing complications and increasing component longevity following total hip replacement (THR). This study aimed to determine the accuracy of a novel virtual reality (VR) platform in assessing component orientation in a simulated THR model. Methods: The VR platform (HTC Vive Pro® system hardware) was compared against the validated Vicon® optical motion capture (MoCap) system. An acetabular cup and femoral stem were manually implanted across a range of orientations into pelvic and femur sawbones, respectively. Simultaneous readings of the acetabular cup operative anteversion (OA) and inclination (OI) and femoral stem alignment (FSA) and neck anteversion (FNA) were obtained from the VR and MoCap systems. Statistical analysis was performed using Pearson product-moment correlation coefficient (PPMCC) (Pearson's r) and linear regression (R2). Results: A total of 55 readings were obtained for the acetabular cup and 68 for the femoral stem model. The mean average differences in OA, OI, FSA and FNA between the systems were 3.44°, -0.01°, 0.01° and -0.04°, respectively. Strong positive correlations were demonstrated between both systems in OA, OI, FSA and FNA, with Pearson's r = 0.92, 0.94, 0.99 and 0.99, and adjusted R2 = 0.82, 0.9, 0.98 and 0.98, respectively. Conclusion: The novel VR platform is highly accurate and reliable in determining both acetabular cup and femoral stem component orientations in simulated THR models. This adaptable and cost-effective digital tracking platform may be modified for use in a range of simulated surgical training and educational purposes, particularly in orthopaedic surgery.

Rehabilitation following rotator cuff repair: A survey exploring clinical equipoise among surgical members of the British Elbow and Shoulder Society.

Background: We investigated clinical equipoise across surgical members of the British Elbow and Shoulder Society (BESS) in relation to rehabilitation following rotator cuff repair. Method: An online survey explored clinical equipoise regarding early patient-directed versus standard rehabilitation after rotator cuff repair to inform the design of a national randomised controlled trial (RCT). It described different clinical scenarios relating to patient age, tear size, location and whether other patient-related and intra-operative factors would influence equipoise. Results: 76 surgeons completed the survey. 81% agreed/ strongly agreed that early mobilisation might benefit recovery; 57% were neutral/ disagreed that this approach risks re-tear. 87% agreed/ strongly agreed that there is clinical uncertainty about the effectiveness of different approaches to rehabilitation. As age of the patient and tear size increased, the proportion of respondents who would agree to recruit and accept the outcome of randomisation reduced, and this was compounded if subscapularis was torn. Other factors that influenced equipoise were diabetes and non-secure repair. Conclusion: Surgical members of BESS recognise uncertainty about the effectiveness of different approaches to rehabilitation following rotator cuff repair. We identified a range of factors that influence clinical equipoise that will be considered in the design of a new RCT.

Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study.

OBJECTIVE: To provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year. DESIGN: Population based cohort study. SETTING: Hospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics. PARTICIPANTS: 288 250 arthroscopic shoulder procedures performed in 261 248 patients aged ≥16 years between 1 April 2009 and 31 March 2017. Elective procedures were grouped into subacromial decompression, rotator cuff repair, acromioclavicular joint excision, glenohumeral stabilisation, and frozen shoulder release. MAIN OUTCOME MEASURES: The primary outcomes were rates of serious adverse events (mortality, pulmonary embolism, pneumonia, myocardial infarction, acute kidney injury, stroke, and urinary tract infection) requiring inpatient care within 90 days post-surgery. Secondary outcomes were specific adverse event rates at 90 days, and reoperations (including for deep infection) within one year. RESULTS: The overall rate of complications within 90 days after arthroscopic shoulder surgery (including reoperation) was low at 1.2% (95% confidence interval 1.2% to 1.3%), with one in 81 patients at risk, and varied according to type of procedure, from 0.6% (0.5% to 0.8%) for glenohumeral stabilisation to 1.7% (1.5% to 1.8%) for frozen shoulder release. After adjustment for age, comorbidities, and sex, no effect of procedure type was observed. Pneumonia was the most common adverse event (0.3%, 0.3% to 0.4%), with one in 303 patients at risk. Pulmonary embolic events were rare, at 0.1% (0.1% to 0.1%), with one in 1428 patients at risk. At one year, the overall rate for reoperation was 3.8% (3.8% to 3.9%), with one in 26 patients at risk, ranging from 2.7% (2.5% to 3.0%) for glenohumeral stabilisation to 5.7% (5.4% to 6.1%) for frozen shoulder release. The overall rate of further surgery for deep infection was low, at 0.1% (0.1% to 0.1%), with one in 1111 patients at risk, but was higher after rotator cuff repair (0.2%, 0.2% to 0.2%), with one in 526 patients at risk. Over the study period the number of arthroscopic shoulder procedures increased, except for subacromial decompression, which decreased. CONCLUSIONS: The findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low. Nevertheless, serious complications do occur, and include the risk of reoperation in one in 26 patients within one year. STUDY REGISTRATION: Clinical. TRIALS: gov NCT03573765.

How long does an elbow replacement last? A systematic review and meta-analysis of case-series and national registry reports with more than 10 years of follow-up.

BACKGROUND AND PURPOSE: This study aims to determine, for the first time, generalizable data on the longevity and long-term function of elbow replacements. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and Embase for articles reporting 10-year or greater survival of total elbow replacements (TERs) and distal humeral hemiarthroplasty. Implant survival and patient reported outcome measures (PROMs) data were extracted. National joint replacement registries were also analyzed. We weighted each series and calculated a pooled survival estimate at 10, 15, and 20 years. For PROMs we pooled the standardized mean difference (SMD) at 10 years. FINDINGS: Despite its widespread use, we identified only 9 series reporting all-cause survival of 628 linked TERs and 610 unlinked TERs and no series for distal humeral hemiarthroplasty. The studied population was treated for rheumatoid arthritis in over 90% of cases. The estimated 10-year survival for linked TERs was 92% (95% CI 90-95) and unlinked TERs 84% (CI 81-88). 2 independent registries contributed 32 linked TERs and 530 unlinked TERs. The pooled registry 10-year survival for unlinked TERs was 86% (CI 83-89). Pooled 10-year PROMs from 164 TERs (33 linked and 131 unlinked), revealed a substantial improvement from baseline scores (SMD 2.7 [CI 1.6-3.8]). INTERPRETATION: Over 80% of all elbow replacements and over 90% of linked elbow replacements can last more than 10 years with sustained patient-reported benefits. This information is long overdue and will be particularly useful to patients as well as healthcare providers.

A systematic review of post-pancreatectomy haemorrhage management stratified according to ISGPS grading.

BACKGROUND: Morbidity and mortality from post-pancreatectomy haemorrhage (PPH) remains high. The International Study Group of Pancreatic Surgery (ISGPS) published guidelines to standardise definitions of PPH severity, management and reporting. This study aimed to i) identify the number of studies reporting PPH using ISGPS guidelines (Grade A, B or C) and ii) describe treatment modality success by grade. METHODS: A systematic literature review was performed, identifying studies reporting PPH by ISGPS Grade and their subsequent management. RESULTS: Of 62 studies reporting on PPH management, 17 (27.4%) stratified by ISGPS guidelines and included 608 incidences of PPH: 48 Grade A, 274 Grade B (62 early, 166 late, 46 unspecified) and 286 Grade C. 96% of Grade A PPH were treated conservatively. Of 62 early Grade B, 54.8% were managed conservatively and 37.1% surgically. Late Grade B were managed non-operatively in 25.3% (42/166), with successful endoscopy in 90.9% (10/11) and angiography in 90.3% (28/31). In Grade C, endoscopic treatment was successful in 64.4% (29/45) and angiography in 90.8% (108/119). Surgical intervention was required in 43.5% early Grade B, 7.8% late Grade B and 33.2% Grade C. CONCLUSION: PPH grading is underreported and despite guidelines, inconsistencies remain when using definitions and reporting of outcomes.