Aims. Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods. The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch–Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results. The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion. Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253–9

A recent Supreme Court ruling in the United Kingdom has significantly altered the emphasis of informed consent, moving from a historically ‘doctor-focused’ to a more ‘patient-focused’ approach, in line with the situation in other international jurisdictions. . The reasons for the change are discussed with some recommendations about how our attitudes need to change in the future. Cite this article: Bone Joint J 2015;97-B:1159–61

Our aim in this paper was to investigate the guidelines and laws governing informed consent in the English-speaking world. We noted a recent divergence from medical paternalism within the United Kingdom, highlighted by the Montgomery v Lanarkshire Health Board ruling of 2015. We investigated the situation in the United Kingdom, Australia, New Zealand, Canada, and the United States of America. We read the national guidance regarding obtaining consent for surgical intervention for each country. We used the references from this guidance to identify the laws that helped inform the guidance, and reviewed the court documents for each case. There has been a trend towards a more patient-focused approach in consent in each country. Surgeons should be aware of the guidance and legal cases so that they can inform patients fully, and prevent legal problems if outdated practices are followed. Cite this article: Bone Joint J 2018;100-B:687–92

Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery. Cite this article: Bone Joint J 2019;101-B:355–360

Traditionally, informed consent for clinical research involves the patient reading an approved Participant Information Sheet, considering the information presented and having as much time as they need to discuss the study information with their friends and relatives, their clinical care and the research teams. This system works well in the ‘planned’ or ‘elective’ setting. But what happens if the patient requires urgent treatment for an injury or emergency?. This article reviews the legal framework which governs informed consent in the emergency setting, discusses how the approach taken may vary according to the details of the emergency and the treatment required, and reports on the patients’ view of providing consent following a serious injury. We then provide some practical tips for managing the process of informed consent in the context of injuries and emergencies. Cite this article: Bone Joint J 2017;99-B:147–150

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of “failure to warn”, i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on “failure to warn” and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550–555

The British Orthopaedic Association has endorsed a website, . www.orthoconsent.com. , allowing surgeons free access to a bank of pre-written consent forms. These are designed to improve the level of information received by the patient and lessen the risk of successful litigation against surgeons and Health Trusts

Telehealth has the potential to change the way we approach patient care. From virtual consenting to reducing carbon emissions, costs, and waiting times, it is a powerful tool in our clinical armamentarium. There is mounting evidence that remote diagnostic evaluation and decision-making have reached an acceptable level of accuracy and can safely be adopted in orthopaedic surgery. Furthermore, patients’ and surgeons’ satisfaction with virtual appointments are comparable to in-person consultations. Challenges to the widespread use of telehealth should, however, be acknowledged and include the cost of installation, training, maintenance, and accessibility. It is also vital that clinicians are conscious of the medicolegal and ethical considerations surrounding the medium and adhere strictly to the relevant data protection legislation and storage framework. It remains to be seen how organizations harness the full spectrum of the technology to facilitate effective patient care. Cite this article: Bone Joint J 2023;105-B(8):843–849

Aims. Reverse total shoulder arthroplasty (rTSA) can be used in complex cases when the glenoid requires reconstruction. In this study, a baseplate with composite bone autograft and a central trabecular titanium peg was implanted, and its migration was assessed for two years postoperatively using radiostereometric analysis (RSA). Methods. A total of 14 patients who underwent a rTSA with an autograft consented to participate. Of these, 11 had a primary rTSA using humeral head autograft and three had a revision rTSA with autograft harvested from the iliac crest. The mean age of the patients was 66 years (39 to 81). Tantalum beads were implanted in the scapula around the glenoid. RSA imaging (stereographic radiographs) was undertaken immediately postoperatively and at three, six, 12, and 24 months. Analysis was completed using model-based RSA software. Outcomes were collected preoperatively and at two years postoperatively, including the Oxford Shoulder Score, the American Shoulder and Elbow Score, and a visual analogue score for pain. A Constant score was also obtained for the assessment of strength and range of motion. Results. RSA analysis showed a small increase in all translation and rotational values up to six months postoperatively, consistent with settling of the implant. The mean values plateaued by 12 months, with no evidence of further migration. In four patients, there was significant variation outside the mean, which corresponded to postoperative complications. There was a significant improvement in the clinical and patient-reported outcomes from the preoperative values to those at two years postoperatively (p < 0.001). Conclusion. These findings show, using RSA, that a glenoid baseplate composite of a trabecular titanium peg with autograft stabilizes within the glenoid about 12 months after surgery, and reinforce findings from a previous study of this implant/graft with CT scans at two years postoperatively, indicating that this type of structural composite results in sound early fixation. Cite this article: Bone Joint J 2023;105-B(8):912–919

Aims. To identify the incidence and risk factors for five-year same-site recurrent disc herniation (sRDH) after primary single-level lumbar discectomy. Secondary outcome was the incidence and risk factors for five-year sRDH reoperation. Methods. A retrospective study was conducted using prospectively collected data and patient-reported outcome measures, including the Oswestry Disability Index (ODI), between 2008 and 2019. Postoperative sRDH was identified from clinical notes and the centre’s MRI database, with all imaging providers in the region checked for missing events. The Kaplan-Meier method was used to calculate five-year sRDH incidence. Cox proportional hazards model was used to identify independent variables predictive of sRDH, with any variable not significant at the p < 0.1 level removed. Hazard ratios (HRs) were calculated with 95% confidence intervals (CIs). Results. Complete baseline data capture was available for 733 of 754 (97.2%) consecutive patients. Median follow-up time for censored patients was 2.2 years (interquartile range (IQR) 1.0 to 5.0). sRDH occurred in 63 patients at a median 0.8 years (IQR 0.5 to 1.7) after surgery. The five-year Kaplan-Meier estimate for sRDH was 12.1% (95% CI 9.5 to 15.4), sRDH reoperation was 7.5% (95% CI 5.5 to 10.2), and any-procedure reoperation was 14.1% (95% CI 11.1 to 17.5). Current smoker (HR 2.12 (95% CI 1.26 to 3.56)) and higher preoperative ODI (HR 1.02 (95% CI 1.00 to 1.03)) were independent risk factors associated with sRDH. Current smoker (HR 2.15 (95% CI 1.12 to 4.09)) was an independent risk factor for sRDH reoperation. Conclusion. This is one of the largest series to date which has identified current smoker and higher preoperative disability as independent risk factors for sRDH. Current smoker was an independent risk factor for sRDH reoperation. These findings are important for spinal surgeons and rehabilitation specialists in risk assessment, consenting patients, and perioperative management. Cite this article: Bone Joint J 2023;105-B(3):315–322

Aims. The aim of this study was to inform the epidemiology and treatment of slipped capital femoral epiphysis (SCFE). Methods. This was an anonymized comprehensive cohort study, with a nested consented cohort, following the the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework. A total of 143 of 144 hospitals treating SCFE in Great Britain participated over an 18-month period. Patients were cross-checked against national administrative data and potential missing patients were identified. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. A total of 486 children (513 hips) were newly affected, with a median of two patients (interquartile range 0 to 4) per hospital. The annual incidence was 3.34 (95% confidence interval (CI) 3.01 to 3.67) per 100,000 six- to 18-year-olds. Time to diagnosis in stable disease was increased in severe deformity. There was considerable variation in surgical strategy among those unable to walk at diagnosis (66 urgent surgery vs 43 surgery after interval delay), those with severe radiological deformity (34 fixation with deformity correction vs 36 without correction) and those with unaffected opposite hips (120 prophylactic fixation vs 286 no fixation). Independent risk factors for avascular necrosis (AVN) were the inability of the child to walk at presentation to hospital (adjusted odds ratio (aOR) 4.4 (95% CI 1.7 to 11.4)) and surgical technique of open reduction and internal fixation (aOR 7.5 (95% CI 2.4 to 23.2)). Overall, 33 unaffected untreated opposite hips (11.5%) were treated for SCFE by two-year follow-up. Age was the only independent risk factor for contralateral SCFE, with age under 12.5 years the optimal cut-off to define ‘at risk’. Of hips treated with prophylactic fixation, none had SCFE, though complications included femoral fracture, AVN, and revision surgery. PROMs demonstrated the marked impact on quality of life on the child because of SCFE. Conclusion. The experience of individual hospitals is limited and mechanisms to consolidate learning may enhance care. Diagnostic delays were common and radiological severity worsened with increasing time to diagnosis. There was unexplained variation in treatment, some of which exposes children to significant risks that should be evaluated through randomized controlled trials. Cite this article: Bone Joint J 2022;104-B(4):519–528

Aims. Total ankle arthroplasty (TAA) surgery is complex and attracts a wide variety of complications. The literature lacks consistency in reporting adverse events and complications. The aim of this article is to provide a comprehensive analysis of each of these complications from a literature review, and to compare them with rates from our Unit, to aid clinicians with the process of informed consent. Patients and Methods. A total of 278 consecutive total ankle arthroplasties (251 patients), performed by four surgeons over a six-year period in Wrightington Hospital (Wigan, United Kingdom) were prospectively reviewed. There were 143 men and 108 women with a mean age of 64 years (41 to 86). The data were recorded on each follow-up visit. Any complications either during initial hospital stay or subsequently reported on follow-ups were recorded, investigated, monitored, and treated as warranted. Literature search included the studies reporting the outcomes and complications of TAA implants. Results. There were wound-healing problems in nine ankles (3.2%), superficial infection in 20 ankles (7.2%), and deep infection in six ankles (2.2%). Intraoperative fractures occurred in medial malleoli in 27 ankles (9.7%) and in lateral malleoli in four ankles (1.4%). Aseptic loosening and osteolysis were seen 16 ankles (5.8%). Fracture of the polyethylene component occurred in one ankle (0.4%) and edge-loading in seven ankles (2.5%). We observed medial gutter pain in 31 ankles (11.1%). The incidence of thromboembolism occurred in two ankles (0.7%). The results were found to be comparable to the previously reported complications of total ankle arthroplasty in the literature. Conclusion. Total ankle arthroplasty continues to evolve and improve the ankle function. Despite high overall complication rates with TAA surgery, most complications appear to be minor and do not affect final clinical outcome. Our results and literature review will help in the consent process and provide detailed complication rates for an informed consent. Cite this article: Bone Joint J 2018;100-B:1352–8

Aims. Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods. Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results. In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion. This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471

Aims. The aim of this study was to evaluate the epidemiology and treatment of Perthes’ disease of the hip. Methods. This was an anonymized comprehensive cohort study of Perthes’ disease, with a nested consented cohort. A total of 143 of 144 hospitals treating children’s hip disease in the UK participated over an 18-month period. Cases were cross-checked using a secondary independent reporting network of trainee surgeons to minimize those missing. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. Overall, 371 children (396 hips) were newly affected by Perthes’ disease arising from 63 hospitals, with a median of two patients (interquartile range 1.0 to 5.5) per hospital. The annual incidence was 2.48 patients (95% confidence interval (CI) 2.20 to 2.76) per 100,000 zero- to 14-year-olds. Of these, 117 hips (36.4%) were treated surgically. There was considerable variation in the treatment strategy, and an optimized decision tree identified joint stiffness and age above eight years as the key determinants for containment surgery. A total of 348 hips (88.5%) had outcomes to two years, of which 227 were in the late reossification stage for which a hip shape outcome (Stulberg grade) was assigned. The independent predictors of a poorer radiological outcome were female sex (odds ratio (OR) 2.27 (95% CI 1.19 to 4.35)), age above six years (OR 2.62 (95% CI (1.30 to 5.28)), and over 50% radiological collapse at inclusion (OR 2.19 (95% CI 0.99 to 4.83)). Surgery had no effect on radiological outcomes (OR 1.03 (95% CI 0.55 to 1.96)). PROMs indicated the marked effect of the disease on the child, which persisted at two years. Conclusion. Despite the frequency of containment surgery, we found no evidence of improved outcomes. There appears to be a sufficient case volume and community equipoise among surgeons to embark on a randomized clinical trial to definitively investigate the effectiveness of containment surgery. Cite this article: Bone Joint J 2022;104-B(4):510–518

Aims. One-stage revision hip arthroplasty for periprosthetic joint infection (PJI) has several advantages; however, resection of the proximal femur might be necessary to achieve higher success rates. We investigated the risk factors for resection and re-revisions, and assessed complications and subsequent re-revisions. Methods. In this single-centre, case-control study, 57 patients who underwent one-stage revision arthroplasty for PJI of the hip and required resection of the proximal femur between 2009 and 2018 were identified. The control group consisted of 57 patients undergoing one-stage revision without bony resection. Logistic regression analysis was performed to identify any correlation with resection and the risk factors for re-revisions. Rates of all-causes re-revision, reinfection, and instability were compared between groups. Results. Patients who required resection of the proximal femur were found to have a higher all-cause re-revision rate (29.8% vs 10.5%; p = 0.018), largely due to reinfection (15.8% vs 0%; p = 0.003), and dislocation (8.8% vs 10.5%; p = 0.762), and showed higher rate of in-hospital wound haematoma requiring aspiration or evacuation (p = 0.013), and wound revision (p = 0.008). The use of of dual mobility components/constrained liner in the resection group was higher than that of controls (94.7% vs 36.8%; p < 0.001). The presence and removal of additional metal hardware (odds ratio (OR) = 7.2), a sinus tract (OR 4), ten years’ time interval between primary implantation and index infection (OR 3.3), and previous hip revision (OR 1.4) increased the risk of proximal femoral resection. A sinus tract (OR 9.2) and postoperative dislocation (OR 281.4) were associated with increased risk of subsequent re-revisions. Conclusion. Proximal femoral resection during one-stage revision hip arthroplasty for PJI may be required to reduce the risk of of recurrent or further infection. Patients with additional metalware needing removal or transcortical sinus tracts and chronic osteomyelitis are particularly at higher risk of needing proximal femoral excision. However, radical resection is associated with higher surgical complications and increased re-revision rates. The use of constrained acetabular liners and dual mobility components maintained an acceptable dislocation rate. These results, including identified risk factors, may aid in preoperative planning, patient consultation and consent, and intraoperative decision-making. Cite this article: Bone Joint J 2021;103-B(11):1678–1685

Aims. To compare rates of serious adverse events in patients undergoing revision knee arthroplasty with consideration of the indication for revision (urgent versus elective indications), and compare these with primary arthroplasty and re-revision arthroplasty. Methods. Patients undergoing primary knee arthroplasty were identified in the national Hospital Episode Statistics (HES) between 1 April 1997 to 31 March 2017. Subsequent revision and re-revision arthroplasty procedures in the same patients and same knee were identified. The primary outcome was 90-day mortality and a logistic regression model was used to investigate factors associated with 90-day mortality and secondary adverse outcomes, including infection (undergoing surgery), pulmonary embolism, myocardial infarction, and stroke. Urgent indications for revision arthroplasty were defined as infection or fracture, and all other indications (e.g. loosening, instability, wear) were included in the elective indications cohort. Results. A total of 939,021 primary knee arthroplasty procedures were included (939,021 patients), of which 40,854 underwent subsequent revision arthroplasty, and 9,100 underwent re-revision arthroplasty. Revision surgery for elective indications was associated with a 90-day rate of mortality of 0.44% (135/30,826; 95% confidence interval (CI) 0.37 to 0.52) which was comparable to primary knee arthroplasty (0.46%; 4,292/939,021; 95% CI 0.44 to 0.47). Revision arthroplasty for infection was associated with a much higher mortality of 2.04% (184/9037; 95% CI 1.75 to 2.35; odds ratio (OR) 3.54; 95% CI 2.81 to 4.46), as was revision for periprosthetic fracture at 5.25% (52/991; 95% CI 3.94 to 6.82; OR 6.23; 95% CI 4.39 to 8.85). Higher rates of pulmonary embolism, myocardial infarction, and stroke were also observed in the infection and fracture cohort. Conclusion. Patients undergoing revision arthroplasty for urgent indications (infection or fracture) are at higher risk of mortality and serious adverse events in comparison to primary knee arthroplasty and revision arthroplasty for elective indications. These findings will be important for patient consent and shared decision-making and should inform service design for this patient cohort. Cite this article: Bone Joint J 2021;103-B(10):1578–1585

Many hospitals do not have a structured process of consent, the attainment of which can often be rather ‘last-minute’ and somewhat chaotic. This is a surprising state of affairs as spinal surgery is a high-risk surgical specialty with potential for expensive litigation claims. More recently, the Montgomery ruling by the United Kingdom Supreme Court has placed the subject of informed consent into the spotlight. . There is a paucity of practical guidance on how a consent process can be achieved in a busy clinical setting. The British Association of Spinal Surgeons (BASS) has convened a working party to address this need. To our knowledge this is the first example of a national professional body, representing a single surgical specialty, taking such a fundamental initiative. . In a hard-pressed clinical environment, the ability to achieve admission reliably on the day of surgery, in patients at ease with their situation and with little likelihood of late cancellation, will be of great benefit. It will reduce litigation and improve the patient experience. Cite this article: Bone Joint J 2016;98-B:1427–30

Aims. Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common surgical complications. In the UK, the Best Practice Tariff incentivizes the screening of delirium in patients with hip fracture. Further, a National Hip Fracture Database (NHFD) performance indicator is the reduction in the incidence of POD. To aid in its recognition, we sought to determine factors associated with POD and POCD in patients with hip fractures. Methods. We interrogated the NHFD data on patients presenting with hip fractures to our institution from 2016 to 2018. POD was determined using the 4AT score, as recommended by the NHFD and UK Department of Health. POCD was defined as a decline in Abbreviated Mental Test Score (AMTS) of two or greater. Using logistic regression, we adjusted for covariates to identify factors associated with POD and POCD. Results. Of the 1,224 patients presenting in the study period, 1,023 had complete datasets for final analysis. POD was observed in 242 patients (25%). On multivariate analysis only preoperative AMTS and American Society of Anesthesiologists grade (ASA) were independent predictors of POD. Every point increase in AMTS was associated with a fall in the odds of POD by a factor of 0.60 (95% confidence interval (CI) 0.56 to 0.63, p < 0.001). Every grade increase in ASA led to a 1.7-fold increase in the odds of POD (95% CI 1.13 to 2.50, p = 0.009). A preoperative AMTS of less than 8 was strongly predictive of POD with area under the receiver operating characteristic of 0.86 (95% CI 0.84 to 0.89). Only ASA was predictive of POCD—every grade increase in ASA led to a 2.6-fold increase in the odds of POCD (95% CI 1.7 to 4.0, p < 0.001). Conclusion. POD and POCD are common in the hip fracture patients. Preoperative AMTS and ASA are strong predictors of POD, and ASA predictive of POCD. This may aid in the earlier identification of those most at risk and suited for the patient consent and decision-making process. Cite this article: Bone Joint J 2020;102-B(12):1675–1681