We present a review of litigation claims relating
to foot and ankle surgery in the NHS in England during the 17-year period
between 1995 and 2012. A freedom of information request was made to obtain data from
the NHS litigation authority (NHSLA) relating to orthopaedic claims,
and the foot and ankle claims were reviewed. During this period of time, a total of 10 273 orthopaedic claims
were made, of which 1294 (12.6%) were related to the foot and ankle.
1036 were closed, which comprised of 1104 specific complaints. Analysis
was performed using the complaints as the denominator. The cost
of settling these claims was more than £36 million. There were 372 complaints (33.7%) involving the ankle, of which
273 (73.4%) were related to trauma. Conditions affecting the first
ray accounted for 236 (21.4%), of which 232 (98.3%) concerned elective
practice. Overall, claims due to diagnostic errors accounted for
210 (19.0%) complaints, 208 (18.8%) from alleged incompetent surgery
and 149 (13.5%) from alleged mismanagement. Our findings show that the incorrect, delayed or missed diagnosis
of conditions affecting the foot and ankle is a key area for improvement,
especially in trauma practice. Cite this article:
The number of clinical
Payments by the NHS Litigation Authority continue to rise each year, and reflect an increase in successful claims for
Background. In the UK 70,000 knee arthroplasties are performed each year. Although outcomes from knee arthroplasties are usually excellent, they can nevertheless lead to
Claims for clinical
Definitions and perceptions of good and poor outcome vary between patients and surgeons, and perceived inadequate outcome can lead to litigation. We investigated outcomes of litigation claims relating to non-union and deformity following lower limb long bone fractures from 1995 to 2010. The database of all 10456 claims related to Trauma and Orthopaedic Surgery was obtained from the NHS Litigation Authority. Data was searched for “deformity, non-union and mal-union”, excluding spine, arthroplasty, foot and upper limb surgery. The type of complaint, whether defended or not, and costs was analysed. 241 claims met our criteria, 204 of which were closed, and 37 unsettled. Deformity/mal-union constituted 97, and non-union 143. Coronal/sagittal deformity cost £4.2 million, mean £45,487 (60% received compensation). Rotational mal-unions cost £1.6 million, mean £114,263 (87% received compensation). Non-union cost £5.3 million, mean £75,866 (60% received compensation). Mean legal fees for coronal/sagittal deformity was £18,772, rotational deformity £37,384, and non-union £24,680. The total cost of litigation was £12.2 million, with a mean of £59,597 per settled claim. The mean pay-out for all confirmed
The cost of clinical
Background. FORECAST is a prospective longitudinal cohort study exploring mechanism-based prognostic factors for pain persistence in sciatica. Here, we share an update on this largest deeply-phenotyped primary care sciatica cohort. Methods/results. Our cohort includes 180 people with sciatica (score >4 on Stynes’ Sum Score), aged 18–85, within 3 months of symptom onset. Psychosocial factors, self-reported sensory profiling, clinical examination, quantitative sensory testing (QST), biological samples (blood and skin samples), and Magnetic Resonance Neurography of lumbar nerve roots were collected at baseline. Pain persistence was determined at three and twelve months with the Sciatica Bothersomeness Index (SBI) and a numeric pain rating scale (NRS) as primary outcomes. Recruitment nears completion, with 160 participants enrolled to date. 127 and 96 participants have completed 3 and 12 months follow-up respectively. Overall, 56% of our cohort are female, with a mean age (SD) of 54.14yrs (16.57). Ethnicity data approximates local populations. SBI at baseline was (median [IQR]) 13[10-17], and interim longitudinal data shows stepwise improvement at 3 and 12 months. Baseline ‘average’ pain intensity was 5.56 (2.15) for leg pain, and 4.14(2.82) for low back pain (LBP). Overall, pain scores decreased at 3 and 12 months, with greater reductions in leg pain than LBP at 12 months. However, around 55–80% and 40–65% of people reported persistent pain at 3 and 12 months respectively. Conclusion. Leg pain severity was moderate and higher than LBP at baseline. All primary outcome measures demonstrate improvement over time, however 40–65% of patients report persistent pain at 12 months. Conflicts of interest. LR: Paid facilitation of post-graduate courses internationally. SK, MT, FP, KM, WS, CP, CR, SC: No conflicts of interest. GC: Editor in Chief of Health Psychology Review. Director of board of directors, MentalCHealth Care setting NoordWestVlaanderen. JF: Copyright holder of ODI (Oswestry Disability Index). Served on a data monitoring committee for a clinical trial of 2 different surgical approaches to cervical disc herniation (FORVAD). Member of HTA Prioritisation Committee B: Inside hospital Care from 2015-February 2019. Member of HTA Interventional Procedures Panel from 2010–2015. Trustee and board member of 3 spine related charities – Back to Back; British Scoliosis Research Foundation and BackCare. Expert instructed by both claimant and defendant solicitors in
The aim of this study was to review the data held with the NHSLA database over the last 10 years for
Our aim was to determine from the general community an understanding of the implications of informed consent, expectations in regard to self-autonomy, appreciation of risk in surgery, the implications of surgical complications, the degree of acceptability of risk for a given complication and views on surgeon liability. One thousand questionnaires were distributed to members of the general public attending the Palmerston North Hospital as outpatients or visitors (inpatients were excluded). Less than 20% of respondents appreciated the concepts of battery,
The aim is: to point out, in respect of Italian case law trends, the concept and the boundaries of surgeon malpractice liability in evaluating and implanting new prosthesic materials. The surgeon is liable for damages caused by fraudulent intention or fault during his clinical and operating activity. In a civil perspective, it could be the result of either a breach of a contract or a tort, depending on the existing relationship between the surgeon and the patient; but in both case there might be a serious inexperience or a light imprudence or
Shoulder injury related to vaccine administration (SIRVA) is a prolonged episode of shoulder dysfunction that commences within 24 to 48 hours of a vaccination. Symptoms include a combination of shoulder pain, stiffness, and weakness. There has been a recent rapid increase in reported cases of SIRVA within the literature, particularly in adults, and is likely related to the mass vaccination programmes associated with COVID-19 and influenza. The pathophysiology is not certain, but placement of the vaccination in the subdeltoid bursa or other pericapsular tissue has been suggested to result in an inflammatory capsular process. It has been hypothesized that this is associated with a vaccine injection site that is “too high” and predisposes to the development of SIRVA. Nerve conduction studies are routinely normal, but further imaging can reveal deep-deltoid collections, rotator cuff tendinopathy and tears, or subacromial subdeltoid bursitis. However, all of these are common findings within a general asymptomatic population. Medicolegal claims in the UK, based on an incorrect injection site, are unlikely to meet the legal threshold to determine liability. Cite this article:
We assessed the frequency and causes of neurological
deterioration in 59 patients with spinal cord injury on whom reports
were prepared for clinical
Two discrete legal factors enable the surgeon to treat an injured patient the fully informed, autonomous consent of the adult patient with capacity via civil law; and the medical exception to the criminal law. This article discusses current concepts in consent in trauma; and also considers the perhaps less well known medical exception to the Offences against the Person Act 1861, which exempts surgeons from criminal liability as long as they provide ‘proper medical treatment’. Cite this article:
To establish the incidence of litigation in Cauda Equina Syndrome (CES) and the causes of litigation. Review of 10 years of abbreviated records of the National Health Service litigation authority (NHSLA) (1997-2007) and eight years of medical
Fracture is the only clinically relevant aspect of osteoporosis—a major public health problem in many countries. The strongest predictor for a new fragility fracture is a previous one. For instance, a patient with one osteoporotic vertebral compression fracture has about a seven-fold increased hip fracture risk; a patient with two compression fractures a 14-fold hip fracture risk. Today, we have evidence based and efficient osteoporosis drugs as well as non-pharmacologic methods for fracture prophylaxis. In risk group patients it often is possible to halve the fracture risk. The orthopaedic surgeon is the first and sometimes the only doctor a fracture patien sees. Therefore, as orthopaedic surgeons, we have a great opportunity—and indeed an onus—to identify patients with increased fracture risk, and to do something about it. Imagine patients with myocardial infarction or stroke discharged from hospital without blood pressure control or having a biochemical profile taken? Such
The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m2, or THA performed for pain relief in those with severely restricted mobility.Aims
Methods
We review all litigation brought against English Orthopaedic departments involving children under the age of 16 and attempt to highlight areas where they might be avoided. The NHSLA (the National Health Service Litigation Authority) is a special Health Authority responsible for handling
Background Prescriptive guidelines for selection of implants for hip arthroplasty are likely to become increasingly established, on grounds of safety, cost and effectiveness. Such guidelines were introduced in the UK by the National Institute of Clinical Excellence (NICE) in 2000. Most departments were non-compliant in one or more respects, and knowledge of the recommendations was limited among clinicians. Concern exists that the recommendations may replace the Bolam Test in cases of clinical
Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents. Cite this article:
During revision hip surgery, damage to the sciatic nerve is due most commonly to excessive tension. While the nerve is strong in tension and is able to tolerate this remarkably, it is sensitive to lateral compression against angled structures and it is likely that tension causes injury by such pressure. In a personal series of 441 revision hip procedures, sciatic nerve injury occurred in 9 recognised cases:. 2 were complete with no useful recovery. 2 were severe with some incomplete recovery. 3 were predominantly lateral popliteal with incomplete recovery. 2 were transient and clinically fully recovered. In only two of these were the cause and the time of injury identifiable. In these cases, pain was not a serious feature but in eight separate medico-legal cases, burning pain of variable distribution has been the most serious complaint. Medical
Routine metalwork removal, in asymptomatic patients, remains a controversial issue in our daily practice. Current literature emphasized the potential hazards of implant removal and the financial implications encountered from these procedures. However, there is little literature guidance and no published research on current practice. To estimate the current state of practice of orthopaedic surgeons in the United Kingdom regarding implant removal for limb trauma in asymptomatic patients, an analysis of the postal questionnaire replies of 36% (500 out of 1390) of randomly selected UK orthopaedic consultants was performed by two independent observers. 47.4% replies were received. A total of 205 (41%) were found to be suitable for analysis. The most significant results of our study I: 92% of orthopaedic surgeons stated that they do not routinely remove metalwork in asymptomatic skeletally mature patients. II: 60% of trauma surgeons stated that they do routinely remove metalwork in patients aged 16 years and under, while only 12% of trauma surgeons do routinely remove metalwork in the age group between 16–35 years. III: 87% of the practising surgeons indicated that they believe it is reasonable to leave metalwork in for 10 years or more. IV: Only 7% of practising trauma surgeons replied to this questionnaire have departmental or unit policy. No policy is needed for metalwork removal, as most of the orthopaedic surgeons were complying with literature guidance supporting the potential risks associated with implant removal, in spite of the limited number of departmental or units’ policies on implant removal and the paucity of the literature documenting the current practice. However, there is a discrepancy among trauma surgeons in relation to metalwork removal between patient age groups. This indicates guidelines would be helpful to guide the surgeon for the best practice. This is important from a medico-legal standpoint because surgeons are being criticised for not achieving satisfactory results in
We have performed a study comparing the radiological results of Total hip replacements performed by a single, experienced specialist hip surgeon with those reported from the Trent Regional Arthroplasty Study (TRAS) [presented at BOA congress 2000]. Results from TRAS have revealed that inadequate cementation grades and a cement mantle width of <
2mm were the most significant associations predicting early aseptic loosening. Interestingly, their respective incidences were as large as 20% and 50% in a random sample of THRs from the TRAS register. Data is lacking as to whether poorer radiographic cementation grades have a trend towards individual surgeons or whether they are more evenly distributed amongst the surgical population including those adhering to modem techniques. Therefore, we have undertaken an independent review of A-P and lateral radiographs of 33 consecutive Charnley THRs performed by a specialist hip surgeon using carefully controlled modem cementing techniques and compared the results with the same random cohort of THRs from the TRAS. Our results show that the specialist surgeon achieved a significantly higher proportion (82%) of complete cement mantles (>
2mm in all zones) than those achieved by TRAS (50%) [Chi. 2. =7. 79, p=0. 0052]. This suggests that improved cement mantles can be achieved by the adoption of carefully controlled modem cementing techniques. However, use of the Barrack system of grading was unable to detect differences in cementation quality between specialist (88%) and TRAS group (81%) [Chi. 2. =0. 235; p=0. 631 suggesting less sensitivity in this technique for assessing cementation quality. These results are important for the following reasons. Achievement of adequate mantle (>
2mm) can be improved upon by adoption of carefully controlled modem cementing technique. However, regardless of the method of assessment of cementation quality, approximately 18% will appear ‘inadequate’ despite modern techniques suggesting that factors outside the surgeon’s control are involved in determining cementation grade. This has important medico-legal implication in the current climate in which surgeons are being criticised, in
Aims: To determine which radiological features were most significant in aseptic loosening (AL) of Charnley total hip replacement (THR) and to compare the prevalence of these features between a specialist hip surgeon and those from the general setting. Method: An analysis was performed of the initial post-operative radiographs of three groups of Charnley femoral stems: I: Failed stems within 5 years due to AL, as registered in the Trent Regional Arthroplasty Study (TRAS). II: 44 consecutive Charnley THRs performed by a single, ‘specialist’ hip surgeon. III Controls: A randomly selected cohort group from the TRAS (proven to be clinically and radiologically intact at 5 years). Results: The most significant radiographic features of failure were: (i) mantle width <
2mm in any zone giving an odds ratio of 21.0 for failure (CI 3.3 to∞; p<
0.05); (ii) “inadequate” cementation grade (Barrack grades C and D) giving an odds ratio of 9.5 for failure (CI 3.2 to 28; p<
0.05). The specialist hip surgeon achieved a significantly higher proportion (79.5%) of complete cement mantles (>
2mm) than the controls (50%) (Chi^2 = 9.455, df = 1, p=0.002). There were also a higher proportion of adequate cementation grades (88.6% vs 82%) although this difference was not significant (Chi^2= 0.947, df = 1, p=0.330). Conclusion: We have demonstrated features identified on radiographs of Charnley femoral stems predictive of failure. In our study a specialist hip surgeon achieved fewer flaws than those detected across a regional ‘average’. This suggests surgical technique can influence radiological results and thus outcome. This needs to be emphasized, particularly during training, in the hope of improving overall results in the future. However, even a specialist’s cementation appeared inadequate in 11.4% of cases, suggesting that factors outside the surgeon’s control, influence cement grading. This is important from a medico-legal standpoint because surgeons are being criticised for not achieving adequate cementation in
In Sweden 99 % of all complaints against doctors are handled by a public authority, The Medical Responsibility Board (HSAN). This way it is very rare fore a medical complaint to reach the judicial courts in Sweden. HSAN is a national authority that assesses medical
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. 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.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
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:
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. 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.Aims
Patients and Methods
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:
The results of hip and knee replacement surgery
are generally regarded as positive for patients. Nonetheless, they are
both major operations and have recognised complications. We present
a review of relevant claims made to the National Health Service
Litigation Authority. Between 1995 and 2010 there were 1004 claims
to a value of £41.5 million following hip replacement surgery and
523 claims to a value of £21 million for knee replacement. The most common
complaint after hip surgery was related to residual neurological
deficit, whereas after knee replacement it was related to infection.
Vascular complications resulted in the highest costs per case in
each group. Although there has been a large increase in the number of operations
performed, there has not been a corresponding relative increase
in litigation. The reasons for litigation have remained largely
unchanged over time after hip replacement. In the case of knee replacement,
although there has been a reduction in claims for infection, there
has been an increase in claims for technical errors. There has also
been a rise in claims for non-specified dissatisfaction. This information
is of value to surgeons and can be used to minimise the potential
mismatch between patient expectation, informed consent and outcome. Cite this article: