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should be aware of the guidance and legal cases so that they can inform patients fully, and prevent legal problems if outdated practices are followed.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

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

The diagnostic sub-categorization of cauda equina syndrome (CES) is used to aid communication between doctors and other healthcare professionals. It is also used to determine the need for, and urgency of, MRI and surgery in these patients. A recent paper by Hoeritzauer et al (2023) in this journal examined the interobserver reliability of the widely accepted subcategories in 100 patients with cauda equina syndrome. They found that there is no useful interobserver agreement for the subcategories, even for experienced spinal surgeons. This observation is supported by the largest prospective study of the treatment of cauda equina syndrome in the UK by Woodfield et al (2023). If the accepted subcategories are unreliable, they cannot be used in the way that they are currently, and they should be revised or abandoned. This paper presents a reassessment of the diagnostic and prognostic subcategories of cauda equina syndrome in the light of this evidence, with a suggested cure based on a more inclusive synthesis of symptoms, signs, bladder ultrasound scan results, and pre-intervention urinary catheterization.

Cite this article: Bone Joint J 2024;106-B(3):227–231.

The importance of registries has been brought into focus by recent UK national reports focusing on implant (Cumberlege) and surgeon (Paterson) performance. National arthroplasty registries provide real-time, real-world information about implant, hospital, and surgeon performance and allow case identification in the event of product recall or adverse surgical outcomes. They are a valuable resource for research and service improvement given the volume of data recorded and the longitunidal nature of data collection. This review discusses the current value of registry data as it relates to both clinical practice and research.

Cite this article: Bone Joint J 2023;105-B(4):356–360.

The transition from shutdown of elective orthopaedic services to the resumption of pre-COVID-19 activity presents many challenges. These include concerns about patient safety, staff safety, and the viability of health economies. Careful planning is necessary to allow patients to benefit from orthopaedic care in a safe and sustainable manner.

Cite this article: Bone Joint J 2020;102-B(7):807–810.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called ‘stem cell’ preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers.

Cite this article: Bone Joint J 2020;102-B(2):148–154

Aims

The optimal treatment for independent patients with a displaced intracapsular fracture of the hip remains controversial. The recognised alternatives are hemiarthroplasty and total hip arthroplasty. At present there is no established standard of care, with both types of arthroplasty being used in many centres.

In this paper, we critically appraise the recent publication of the United Kingdom Heel Fracture Trial, which concluded that when patients with an absolute indication for surgery were excluded, there was no advantage of surgical over non-surgical treatment in the management of calcaneal fractures.

We believe that selection bias in that study did not permit the authors to reach a firm conclusion that surgery was not justified for most intra-articular calcaneal fractures.

Cite this article: Bone Joint J 2015;97-B:880–2.

The results of the DRAFFT (distal radius acute fracture fixation trial) study, which compared volar plating with Kirschner (K-) wire fixation for dorsally displaced fractures of the distal radius, were published in August 2014. The use of K-wires to treat these fractures is now increasing, with a concomitant decline in the use of volar locking plates.

We provide a critical appraisal of the DRAFFT study and question whether surgeons have been unduly influenced by its headline conclusions.

Cite this article: Bone Joint J 2016;98-B:298–300.

Despite being one of the most common orthopaedic operations, it is still not known how many arthroscopies of the knee must be performed during training in order to develop the skills required to become a Consultant. A total of 54 subjects were divided into five groups according to clinical experience: Novices (n = 10), Junior trainees (n = 10), Registrars (n = 18), Fellows (n = 10) and Consultants (n = 6). After viewing an instructional presentation, each subject performed a simple diagnostic arthroscopy of the knee on a simulator with visualisation and probing of ten anatomical landmarks. Performance was assessed using a validated global rating scale (GRS). Comparisons were made against clinical experience measured by the number of arthroscopies which had been undertaken, and ROC curve analysis was used to determine the number of procedures needed to perform at the level of the Consultants.

There were marked differences between the groups. There was significant improvement in performance with increasing experience (p < 0.05).

ROC curve analysis identified that approximately 170 procedures were required to achieve the level of skills of a Consultant.

We suggest that this approach to identify what represents the level of surgical skills of a Consultant should be used more widely so that standards of training are maintained through the development of an evidenced-based curriculum.

Cite this article: Bone Joint J 2015;97-B:1309–15.

Payments by the NHS Litigation Authority continue to rise each year, and reflect an increase in successful claims for negligence against NHS Trusts. Information about the reasons for which Trusts are sued in the field of trauma and orthopaedic surgery is scarce.

We analysed 130 consecutive cases of alleged clinical negligence in which the senior author had been requested to act as an expert witness between 2004 and 2006, and received information on the outcome of 97 concluded cases from the relevant solicitors. None of the 97 cases proceeded to a court hearing. Overall, 55% of cases were abandoned by the claimants’ solicitors, and the remaining 45% were settled out of court. The cases were settled for sums ranging from £4500 to £2.7 million, the median settlement being £45 000. The cases that were settled out of court were usually the result of delay in treatment or diagnosis, or because of substandard surgical technique.

The Canadian Orthopaedic Trauma Society was started in an endeavour to answer the difficult problem of obtaining enough patients to perform top-quality research into fractures. By maintaining a high standard, including randomised study design, inclusivity, open discussion among surgeons and excellent long-term follow-up, this group has become a leader in the orthopaedic research community. This annotation describes the short history, important components and spirit necessary to build a research community or team which will function well despite the difficult research environment facing individual surgeons.

Since the introduction of the first National Arthroplasty Register in Sweden in 1975, many other countries have tried to adopt the successful Scandinavian system. However, not all have overcome the political and practical difficulties of establishing a working register. We have surveyed the current registries to establish the key factors required for an effective database. We have received detailed information from 15 arthroplasty registers worldwide. The legal conditions under which they operate together with the methods of collection and handling of the data differ widely, but the fulfilment of certain criteria is necessary achieve a high degree of completeness of the data to ensure the provision of statistically relevant information.

Procedures performed at the incorrect anatomical site are commonly perceived as being relatively rare. However, they can be a devastating event for patients and doctors. Evidence from the United Kingdom and North America suggests that wrong-site, wrong-procedure and wrong-patient events occur more commonly than we think. Furthermore, their incidence may be increasing as NHS Trusts increase the volume and complexity of procedures undertaken in order to cope with increasing demands on the system. In previous studies from North America orthopaedic surgery has been found to be the worst-offending specialty.

In this paper we review the existing literature on wrong-site surgery and analyse data from the National Patient Safety Agency and NHS Litigation Authority on 292 cases of wrong-site surgery in England and Wales. Orthopaedic surgery accounted for 87 (29.8%) of these cases. In the year 2006 to 2007, the rate of wrong-site surgery in England and Wales was highest in orthopaedic surgery, in which the estimated rate was 1:105 712 cases.

Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.