Reverse total shoulder replacement versus anatomical total shoulder replacement for osteoarthritis: population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England.

OBJECTIVES: To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. DESIGN: Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. SETTING: Public hospitals and publicly funded procedures at private hospitals in England, 2012-20. PARTICIPANTS: Adults aged 60 years or older who underwent RTSR or TSR for osteoarthritis with intact rotator cuff tendons. Patients were identified from the National Joint Registry and linked to NHS Hospital Episode Statistics and civil registration mortality data. Propensity score matching and inverse probability of treatment weighting were used to balance the study groups. MAIN OUTCOME MEASURES: The main outcome measure was revision surgery. Secondary outcome measures included serious adverse events within 90 days, reoperations within 12 months, prolonged hospital stay (more than three nights), change in Oxford Shoulder Score (preoperative to six month postoperative), and lifetime costs to the healthcare service. RESULTS: The propensity score matched population comprised 7124 RTSR or TSR procedures (126 were revised), and the inverse probability of treatment weighted population comprised 12 968 procedures (294 were revised) with a maximum follow-up of 8.75 years. RTSR had a reduced hazard ratio of revision in the first three years (hazard ratio local minimum 0.33, 95% confidence interval 0.18 to 0.59) with no clinically important difference in revision-free restricted mean survival time, and a reduced relative risk of reoperations at 12 months (odds ratio 0.45, 95% confidence interval 0.25 to 0.83) with an absolute risk difference of -0.51% (95% confidence interval -0.89 to -0.13). Serious adverse events and prolonged hospital stay risks, change in Oxford Shoulder Score, and modelled mean lifetime costs were similar. Outcomes remained consistent after weighting. CONCLUSIONS: This study's findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact rotator cuff tendons. Despite a significant difference in the risk profiles of revision surgery over time, no statistically significant and clinically important differences between RTSR and TSR were found in terms of long term revision surgery, serious adverse events, reoperations, prolonged hospital stay, or lifetime healthcare costs.

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.

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.

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.

Temporal Trends and Geographical Variation in Dupuytren Disease Surgery in England: A Population-Based Cohort Study.

BACKGROUND: Dupuytren disease (DD) is a common fibroproliferative disease of the palmar fascia. The mainstay of DD treatment in England is surgery with either percutaneous needle fasciotomy, limited fasciectomy, or dermofasciectomy. This study aimed to investigate the temporal trends and geographical variation of primary DD surgery in England. METHODS: A longitudinal population-based cohort study was perfomed using the Hospital Episode Statistics database from April 1, 2007, to March 31, 2017. Directly standarized rates were estimated over time (between financial years 2007-2008 and 2016-2017) and by geographic region (by clinical commissioning groups [CCGs]; financial years 2010-2011, 2013-2014, and 2016-2017). The Office for National Statistics midyear population estimates were used as the reference population. MAIN FINDINGS: Primary DD surgery was undertaken at a steadily increasing rate from financial year 2007 to 2008, to 2016 to 2017 in England. There was a striking 3.6-fold variation in the rates of primary DD surgery among National Health Service CCGs in England place of residence. CONCLUSIONS: This significant variation in DD surgical treatment in England suggests a need for the development of standardized surgical practice across all CCGs and National Health Service hospitals, promoting equality of access to cost-effective health care.

Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study.

BACKGROUND: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. METHODS: A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society's (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. RESULTS: The BESS surgeons' survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. CONCLUSIONS: Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis: analysis of a national cohort of 43 076 surgeries.

OBJECTIVES: To determine the incidence of further procedures and serious adverse events (SAEs) requiring admission to hospital following elective surgery for base of thumb osteoarthritis (BTOA), and the patient factors associated with these outcomes. DESIGN: Population based cohort study. SETTING: National Health Service using the national Hospital Episode Statistics data set linked to mortality records over a 19-year period (01 April 1998-31 March 2017). PARTICIPANTS: 43 076 primary surgeries were followed longitudinally in secondary care until death or migration on 37 329 patients over 18 years of age. MAIN OUTCOME MEASURES: Incidence of further thumb base procedures (including revision surgery or intra-articular steroid injection) at any time postoperatively, and local wound complications and systemic events (myocardial infarction, stroke, respiratory tract infection, venous thromboembolic events, urinary tract infection or renal failure) within 30 and 90 days. To identify patient factors associated with outcome, Fine and Gray model regression analysis was used to adjust for the competing risk of mortality in addition to age, overall comorbidity and socioeconomic status. RESULTS: Over the 19 years, there was an increasing trend in surgeries undertaken. The rate of further thumb base procedures after any surgery was 1.39%; the lowest rates after simple trapeziectomy (1.12%), the highest rates after arthroplasty (3.84%) and arthrodesis (3.5%). When matched for age, comorbidity and socioeconomic status, those undergoing arthroplasty and arthrodesis were 2.5 times more likely to undergo a further procedure (subHR 2.51 (95% CI 1.81 to 3.48) and 2.55 (1.91 to 3.40)) than those undergoing simple trapeziectomy. Overall complication rates following surgery were 0.22% for serious local complications and 0.58% for systemic events within 90 days of surgery. CONCLUSIONS: The number of patients proceeding to BTOA surgery has increased over the last 19 years, with a low rate of further thumb base procedures and SAEs after surgery overall registered. Arthrodesis and arthroplasty had a significantly higher revision rate. TRIAL REGISTRATION NUMBER: NCT03573765.

Anterior knee pain from the evolutionary perspective.

BACKGROUND: This paper describes the evolutionary changes in morphology and orientation of the PFJ using species present through our ancestry over 340 million years. METHODS: 37 specimens from the Devonian period to modern day were scanned using a 64-slice CT scanner. 3D geometries were created following routine segmentation and anatomical measurements taken from standardised bony landmarks. RESULTS: Findings are described according to gait strategy and age. The adoption of an upright bi-pedal stance caused a dramatic change in the loading of the PFJ which has subsequently led to changes in the arrangement of the PFJ. From Devonian to Miocene periods, our sprawling and climbing ancestors possessed a broad knee with a shallow, centrally located trochlea. A more rounded knee was present from the Paleolithic period onwards in erect and bipedal gait types (aspect ratio 0.93 vs 1.2 in late Devonian), with the PFJ being placed lateral to the midline compared to the medial position in quadrapeds. The depth of the trochlea groove was maximal in the Miocene period of the African ground apes with associated acute sulcus angles in Gorilla (117°) becoming more flattened towards the modern human (138°). CONCLUSIONS: The evolving bipedal gait lead to anteriorisation of the patellofemoral joint, flattening of the trochlea sulcus, in a more lateral, dislocation prone arrangement. Ancestral developments might help explain the variety of presentations of anterior knee pain and patellofemoral instability.

Patch augmentation surgery for rotator cuff repair: the PARCS mixed-methods feasibility study.

BACKGROUND: A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). OBJECTIVES: The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. DESIGN: A mixed-methods feasibility study of a randomised controlled trial. DATA SOURCES: MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. METHODS: The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society's surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2-6. RESULTS: The systematic review comprised 52 studies; only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5-152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. LIMITATIONS: The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. CONCLUSION: The need for further clinical studies was clear, particularly given the range and number of different patches available. FUTURE WORK: Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. STUDY REGISTRATION: The systematic review is registered as PROSPERO CRD42017057908. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 13. See the NIHR Journals Library website for further project information.

Shoulder muscles and tendons allow us to move our arms to carry out daily activities, work and play sports. Disease and injury of these tendons can cause significant long-term disability. Early treatment of these tendon problems usually involves painkillers, injections and physiotherapy. However, many patients whose symptoms do not improve may need surgery to repair these tendons. Unfortunately, around 40% of surgical tendon repairs fail within 12 months. As such, these operations need to be improved. A promising approach is to use a patch to support the repair while the tendon heals; this patch is often used in a similar way to a plaster. However, it is not yet clear whether or not using a patch improves patient health and, if so, whether or not it makes enough of a difference to justify the additional cost to the NHS. A scientific study called a randomised controlled trial is needed to fairly assess the value of surgery with a patch in people requiring a tendon repair. This study must be carefully designed so that it is acceptable to patients and surgeons, among others, and feasible to run. We conducted a multistage study to explore whether or not a potential trial design could be achieved. We searched the scientific literature for previous research that had studied using patches for repairing shoulder tendons. We surveyed shoulder surgeons, including those who had previously been involved shoulder randomised controlled trials. We conducted four focus groups with stakeholders. Initial agreement on the best way to run a randomised controlled trial of patches in shoulder surgery was achieved using online questionnaires. Finally, we held a 2-day meeting to scrutinise the study findings and the relevant issues. Two potential studies were recommended, as was the need for closer monitoring of patch safety.

Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?

'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias arising from the beliefs and expectations of these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring that experimental and control treatments look the same. However, there is a debate about if we should measure whether blinding has been successful, this manuscript will discuss this controversy, including the benefits and risks of measuring blinding within the randomised controlled trial.

Shoulder Pain Diagnosis, Treatment and Referral Guidelines for Primary, Community and Intermediate Care.

These care pathway guidelines for the shoulder have been written in collaboration with the NHS Evidence Based Interventions (EBI) programme. The EBI programme is a partnership between the Academy of Medical Royal Colleges, NHS Clinical Commissioners, the National Institute for Health and Care Excellence, as well as NHS England and Improvement.

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis.

OBJECTIVES: Intra-articular steroid injection is commonly used to treat base of thumb osteoarthritis (BTOA), despite a lack of large-scale data on safety and effectiveness. We estimate the incidence of serious complications and further procedures following BTOA injection, including the risk of post-operative serious surgical site infection for subsequent operative intervention. METHODS: Hospital Episode Statistics data linked to mortality records from 1 April 1998 to 31 March 2017 were used to identify all BTOA injections undertaken in adults in the National Health Service secondary care in England. Patients were followed up longitudinally until death or 31 March 2017. A multivariable regression with a Fine and Gray model adjusting for the competing risk of mortality in addition to age, sex and socioeconomic deprivation was used to identify factors associated with progression to further procedure. Secondary outcomes included serious complications after injection and subsequent surgical site infection. RESULTS: A total of 19 120 primary injections were performed during the 19-year period in 18 356 patients. Of these 76.5% were female; mean age 62 years (s.d. 10.6); 50.48% underwent further procedure; 22.40% underwent surgery. Median time to further intervention was 412 days (IQR 110-1945). Female sex was associated with increased risk of proceeding to surgery. Serious complication rate following injection was 0.04% (0.01-0.08) within 90 days. Of those proceeding to surgery 0.16% (0.06-0.34) presented with a wound infection within 30 days and 90 days, compared with an overall post-operative wound infection rate of 0.03% (0.02-0.05). CONCLUSIONS: Very low rates of serious complications were identified following BTOA injections performed in secondary care; only one in five patients proceeded to subsequent surgery. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, https://www.clinicaltrials.gov, NCT03573765.

Serious postoperative complications and reoperation after carpal tunnel decompression surgery in England: a nationwide cohort analysis.

BACKGROUND: Carpal tunnel decompression surgery to treat carpal tunnel syndrome is a common procedure, yet data on safety and effectiveness of the operation in the general population remain scarce. We aimed to estimate the incidence of reoperation and serious postoperative complications (requiring admission to hospital or further surgery) following carpal tunnel decompression in routine clinical practice and to identify the patient factors associated with these adverse outcomes. METHODS: We did a nationwide cohort analysis including all carpal tunnel decompression surgeries in patients aged 18 years or older, done in the National Health Service in England between April 1, 1998, and March 31, 2017, using the Hospital Episode Statistics dataset linked to mortality records. Patients were followed-up until death or until the end of the study (March 31, 2017). Primary outcomes were the overall incidence of carpal tunnel decompression reoperation and serious postoperative complications (surgical site infection or dehiscence, or neurovascular or tendon injury, requiring admission to hospital or further surgery) within 30 days and 90 days after surgery. Multivariable Cox regression analysis was used to identify factors influencing complications and reoperation, and the Fine and Gray method was used to adjust for the competing risk of mortality. This study is registered with ClinicalTrials.gov, NCT03573765. FINDINGS: 855 832 carpal tunnel decompression surgeries were done between April 1, 1998, and March 31, 2017 (incidence rate 1·10 per 1000 person-years [95% CI 1·02-1·17]). 29 288 procedures (3·42%) led to carpal tunnel decompression reoperation (incidence rate 3·18 per 1000 person-years [95% CI 3·12-3·23]). Of the 855 832 initial surgeries, 620 procedures (0·070% [95% CI 0·067-0·078]) led to a serious complication within 30 days after surgery, and 698 procedures (0·082% [0·076-0·088]) within 90 days. Local complications within 90 days after surgery were associated with male sex (adjusted hazard ratio 2·32 [95% CI 1·74-3·09]) and age category 18-29 years (2·25 [1·10-4·62]). Male sex (adjusted subhazard ratio 1·09 [95% CI 1·06-1·13]), old age (>80 years vs 50-59 years: 1·09 [1·03-1·15]), and greater levels of comorbidity (Charlson score ≥5 vs 0: 1·25 [1·19-1·32]) and socioeconomic deprivation (most deprived 10% vs least deprived 10%: 1·18 [1·10-1·27]) were associated with increased reoperation risk. INTERPRETATION: To our knowledge, this is the largest national study on carpal tunnel decompression to date, providing strong evidence on serious postoperative complication and reoperation rates. Carpal tunnel decompression appears to be a safe operation in most patients, with an overall serious complication rate (requiring admission to hospital or further surgery) of less than 0·1%. FUNDING: Versus Arthritis; Medical Research Council; Royal College of Surgeons of England and National Joint Registry research fellowship; University of Oxford; National Institute for Health Research; and National Institute for Health Research Biomedical Research Centre, Oxford.

Serious complications and risk of re-operation after Dupuytren's disease surgery: a population-based cohort study of 121,488 patients in England.

Dupuytren's disease (DD) is a common fibro-proliferative disorder of the palm. We estimated the risk of serious local and systemic complications and re-operation after DD surgery. We queried England's Hospital Episode Statistics database and included all adult DD patients who were surgically treated. A longitudinal cohort study and self-controlled case series were conducted. Between 1 April 2007 and 31 March 2017, 121,488 adults underwent 158,119 operations for DD. The cumulative incidence of 90-day serious local complications was low at 1.2% (95% CI 1.1-1.2). However, the amputation rate for re-operation by limited fasciectomy following dermofasciectomy was 8%. 90-day systemic complications were also uncommon at 0.78% (95% CI 0.74-0.83), however operations routinely performed under general or regional anaesthesia carried an increased risk of serious systemic complications such as myocardial infarction. Re-operation was lower than previous reports (33.7% for percutaneous needle fasciotomy, 19.5% for limited fasciectomy, and 18.2% for dermofasciectomy). Overall, DD surgery performed in England was safe; however, re-operation by after dermofasciectomy carries a high risk of amputation. Furthermore, whilst serious systemic complications were unusual, the data suggest that high-risk patients should undergo treatment under local anaesthesia. These data will inform better shared decision-making regarding this common condition.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Shoulder replacement surgery for osteoarthritis and rotator cuff tear arthropathy.

BACKGROUND: Shoulder replacement surgery is an established treatment for patients with end-stage glenohumeral osteoarthritis or rotator cuff tear arthropathy who have not improved with non-operative treatment. Different types of shoulder replacement are commonly used, but their relative benefits and risks compared versus one another and versus other treatments are uncertain. This expanded scope review is an update of a Cochrane Review first published in 2010. OBJECTIVES: To determine the benefits and harms of shoulder replacement surgery in adults with osteoarthritis (OA) of the shoulder, including rotator cuff tear arthropathy (RCTA). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, CINAHL, SportDiscus, and Web of Science up to January 2019. We also searched clinical trial registers, conference proceedings, and reference lists from previous systematic reviews and included studies. SELECTION CRITERIA: We included randomised studies comparing any type of shoulder replacement surgery versus any other surgical or non-surgical treatment, no treatment, or placebo. We also included randomised studies comparing any type of shoulder replacement or technique versus another. Study participants were adults with osteoarthritis of the glenohumeral joint or rotator cuff tear arthropathy. We assessed the following major outcomes: pain, function, participant-rated global assessment of treatment success, quality of life, adverse events, serious adverse events, and risk of revision or re-operation or treatment failure. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. We collected trial data on benefits and harms. MAIN RESULTS: We included 20 studies involving 1083 participants (1105 shoulders). We found five studies comparing one type of shoulder replacement surgery to another type of shoulder replacement surgery, including three studies comparing conventional stemmed total shoulder replacement (TSR) surgery to stemmed humeral hemiarthroplasty. The remaining 15 studies compared one type of shoulder replacement to the same type of replacement performed with a technical modification or a different prosthetic component. We found no studies comparing shoulder replacement surgery to any other type of surgical treatment or to any type of non-surgical treatment. We found no studies comparing reverse total shoulder replacement surgery to any other type of treatment or to any type of replacement. Trial size varied from 16 to 161 participants. Participant mean age ranged from 63 to 81 years. 47% of participants were male. Sixteen trials reported participants with a diagnosis of osteoarthritis and intact rotator cuff tendons. Four trials reported patients with osteoarthritis and a rotator cuff tear or rotator cuff tear arthropathy. All studies were at unclear or high risk of bias for at least two domains, and only one study was free from high risk of bias (included in the main comparison). The most common sources of bias were lack of blinding of participants and assessors, attrition, and major baseline imbalance. Three studies allowed a comparison of conventional stemmed TSR surgery versus stemmed humeral hemiarthroplasty in people with osteoarthritis. At two years, low-quality evidence from two trials (downgraded for bias and imprecision) suggested there may be a small but clinically uncertain improvement in pain and function. On a scale of 0 to 10 (0 is no pain), mean pain was 2.78 points after stemmed humeral hemiarthroplasty and 1.49 points lower (0.1 lower to 2.88 lower) after conventional stemmed TSR. On a scale of 0 to 100 (100 = normal function), the mean function score was 72.8 points after stemmed humeral hemiarthroplasty and 10.57 points higher (2.11 higher to 19.02 higher) after conventional stemmed TSR. There may be no difference in quality of life based on low-quality evidence, downgraded for risk of bias and imprecision. On a scale of 0 to 100 (100 = normal), mean mental quality of life was rated as 57.4 points after stemmed humeral hemiarthroplasty and 1.0 point higher (5.1 lower to 7.1 higher) after conventional stemmed TSR. We are uncertain whether there is any difference in the rate of adverse events or the rate of revision, re-operation, or treatment failure based on very low-quality evidence (downgraded three levels for risk of bias and serious imprecision). The rate of any adverse event following stemmed humeral hemiarthroplasty was 286 per 1000, and following conventional stemmed TSR 143 per 1000, for an absolute difference of 14% fewer events (25% fewer to 21% more). Adverse events included fractures, dislocations, infections, and rotator cuff failure. The rate of revision, re-operation, or treatment failure was 103 per 1000, and following conventional stemmed TSR 77 per 1000, for an absolute difference of 2.6% fewer events (8% fewer to 15% more). Participant-rated global assessment of treatment success was not reported. AUTHORS' CONCLUSIONS: Although it is an established procedure, no high-quality randomised trials have been conducted to determine whether shoulder replacement might be more effective than other treatments for osteoarthritis or rotator cuff tear arthropathy of the shoulder. We remain uncertain about which type or technique of shoulder replacement surgery is most effective in different situations. When humeral hemiarthroplasty was compared to TSR surgery for osteoarthritis, low-quality evidence led to uncertainty about whether there is a clinically important benefit for patient-reported pain or function and suggested there may be little or no difference in quality of life. Evidence is insufficient to show whether TSR is associated with greater or less risk of harm than humeral hemiarthroplasty. Available randomised studies did not provide sufficient data to reliably inform conclusions about adverse events and harm. Although reverse TSR is now the most commonly performed type of shoulder replacement, we found no studies comparing reverse TSR to any other type of treatment.

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

BACKGROUND: Shoulder replacement is an increasingly common treatment for end-stage degenerative shoulder conditions. Some shoulder replacements are unsuccessful and additional operations might be required. It is important for patients and clinicians to know how long shoulder replacements last and how effectively they reduce pain and improve function. This study aims to determine the longevity and long-term efficacy of shoulder replacements. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and Embase from their inception to Sept 24, 2019, for case series and registry data reporting 10-year or longer survival of total shoulder replacements, humeral hemiarthroplasties, and reverse total shoulder replacements of a specific brand of implant. Survival, implant, and patient-reported outcome measures data were extracted. The primary outcome was implant survival. We reviewed and analysed national joint replacement registries separately. We weighted each series by SE and calculated a pooled survival estimate at years 10, 15, and 20. For patient-reported outcome measures we pooled the standardised mean difference at 10 years. This study is registered with PROSPERO, CRD42019140221. FINDINGS: 927 non-duplicate articles were identified by our search, nine articles (reporting ten series) were eligible for analysis of survival and six articles were eligible for analysis of patient reported outcomes. The ten series reported all-cause survival of 529 total shoulder replacements and 364 humeral hemiarthroplasties; no series for reverse total shoulder replacement met the inclusion criteria. The estimated 10-year survival for total shoulder replacement was 94·6% (95% CI 93·6-97·6) and humeral hemiarthroplasties was 90·4% (87·0-94·0). A single registry contributed 7651 total shoulder replacements, 1395 humeral hemiarthroplasties, and 7953 reverse total shoulder replacements. The pooled registry 10-year survival was 92·0% (95% CI 91·0-93·0) for total shoulder replacement, 85·5% (83·3-87·7) for humeral hemiarthroplasties, and 94·4% (93·4-95·7) for patients with osteoarthritis who had reverse total shoulder replacement and 93·6% (91·1-95·8) for patients with rotator cuff arthropathy who had reverse total shoulder replacement. Pooled 10-year patient-reported outcome measures showed a substantial improvement from baseline scores, with a standardised mean difference of 2·13 (95% CI 1·93-2·34). INTERPRETATION: Our data show that approximately 90% of shoulder replacements last for longer than 10 years and patient-reported benefits are sustained. Our findings will be of use to surgeons and patients in the informed consent process and to health-care providers for resource planning. FUNDING: The National Institute for Health Research, the National Joint Registry for England, Wales, Northern Ireland, and Isle of Man, and the Royal College of Surgeons of England.