Abstract: The impact of FOI and the rising tide of litigation have focused clinicians on their vulnerability. As the British Orthopaedic News states, the Bristol Enquiry made 198 recommendations of which only a few were specific to paediatric cardiac surgery. With this climate in mind, a Research Project on a system of Risk Management has been established in Trauma & Orthopaedics and A& E in Sligo General Hospital. A “Clinical Incident Data Collection Form” has been developed to collect and analyse different classifications such as potential risks, near misses, clinical incident, equipment failure and drug error. Trauma, Orthopaedic and Emergency speciality trigger lists will be set up. A Research Officer is in post and a Multidisciplinary Steering Group has been developed, and speciality links have been established. An education programme has commenced for multidisciplinary staff. The aim is to design and test the Clinical Risk Management in action in order to control and reduce risk in clinical care in the Trauma & Orthopaedic and A& E Department in Sligo General Hospital

We summarise and highlight the safety concerns within the field of trauma and orthopaedic surgery with particular emphasis placed on current controversies and reforms within the United Kingdom National Health Service.

Purpose and Background. Clinical practice guidelines (CPGs) recommend self-management for low back pain (LBP). Our recent narrative review on self-management needs revealed a consensus with respect to the critical components of self-management interventions. With mobile health advancements, apps offer innovative support for LBP management. This study aims to identify current apps for the self-management of LBP, assessing them for their quality, intervention content, theoretical approaches, and risk management approaches. Methods and Results. We identified 69 apps for LBP self-management from a systematic search in the UK iTunes and Google Play stores. The most recommended interventions are muscle stretching (n=51, 73.9%), muscle strengthening (n=42, 60.9%), and core stability exercises (n=32, 46.4%). The average MARS (SD) overall score for the included apps was 2.4 (0.44) out of a possible 5 points, with the engagement and information dimension scoring the lowest at 2.1. In terms of theoretical and risk management approaches, no apps offered a theoretical care model and all failed to specify the age group targeted; only one (1.4%) provided a tailored care approach; 18 (26.1%) included intervention progression; and 11 (15.9%) reported management safety checks. Conclusion. This study shows that app developers generally select interventions endorsed by CPGs. However, the application of a biopsychosocial care model is not being considered. Most of them are of low quality, lacking theoretical approaches to care and consideration of associated risks. It is essential to involve clinicians and patients in developing LBP self-management apps to improve the quality and related approach. Conflicts of interest. None. Sources of funding. No funding obtained. This study has been published in JMIR mHealth and uHealth

Prosthetic joint infections (PJI) are devastating complications. Our knowledge on hip fractureassociated hemiarthroplasty PJI (HHA-PJI) is limited compared to elective arthroplasty. The goal of this study was to describe the epidemiology, risk factors, management, and outcomes for HHA-PJI. A population-based (465,000) multicentre retrospective analysis of HHAs between 2006-2018 was conducted. PJI was defined by international consensus and treatment success as no return to theatre and survival to 90 days after the initial surgical management of the infection. Univariate, survival and competing risk regression analyses were performed. 1852 HHAs were identified (74% female; age:84±7yrs;90-day-mortality:16.7%). Forty-three (2.3%) patients developed PJI [77±10yrs; 56% female; 90-day-mortality: 20.9%, Hazard-Ratio 1.6 95%CI 1.1-2.3,p=0.023]. The incidence of HHA-PJI was 0.77/100,000/year and 193/100,000/year for HHA. The median time to PJI was 26 (IQR 20-97) days with 53% polymicrobial growth and 41% multi-drug resistant organisms (MDRO). Competing risk regression identified younger age [Sub-Hazard-Ratio(SHR) 0.86, 95%CI 0.8-0.92,p<0.001], chronic kidney disease (SHR 3.41 95%CI 1.36-8.56, p=0.01), body mass index>35 (SHR 6.81, 95%CI 2.25-20.65, p<0.001), urinary tract infection (SHR 1.89, 95%CI 1.02-3.5, p=0.04) and dementia (SHR 9.4, 95%CI 2.89-30.58,p<0.001) as significant risk factors for developing HHA-PJI. When infection treatment was successful (n=15, 38%), median survival was 1632 days (IQR 829-2084), as opposed to 215 days (IQR 20-1245) in those who failed, with a 90-day mortality of 30%(n=12). There was no significant difference in success among debridement, excision arthroplasty or revision arthroplasty. HHA PJI is uncommon but highly lethal. All currently identified predictors are non-modifiable. Due to the common polymicrobial and MDRO infections our standard antibiotic prophylaxis may not be adequate HHA-PJI is a different disease compared to elective PJI with distinct epidemiology, pathogens, risk factors and outcomes, which require targeted research specific to this unique population

Fracture related infections (FRI) are debilitating complications of musculoskeletal trauma surgery that can result in permanent functional loss or amputation. This study aims to determine risk factors associated with FRI treatment failure, allowing clinicians to optimise them prior to treatment and identify patients at higher risk. A major trauma centre database was retrospectively reviewed over a six-year period. Of the 102 patients identified with a FRI (66 male, 36 female), 29.4% (n=30) had acute infections (onset <6 weeks post-injury), 34.3% (n=35) had an open fracture. Open fractures were classified using Gustilo-Anderson (GA) classification (type 2:n=6, type 3A:n=16, type 3B:n=10, type 3C:n=3). Patients with periprosthetic infections of the hip and knee joint, those without prior fracture fixation, soft tissue infections, diabetic foot ulcers, pressure sore infections, patients who died within one month of injury, <12 months follow-up were excluded. FRI treatment failure was defined as either infection recurrence, non-union, or amputation. Lifestyle, clinical, and intra-operative data were documented via retrospective review of medical records. Factors with a P-value of p<0.05 in univariate analysis were included in a stepwise multivariate logistic regression model. FRI treatment failure was encountered in 35.3% (n=36). The most common FRI site was the femoral shaft (16.7%; n=17), and 15.7% (n=16) presented with signs of systemic sepsis. 20.6% (n=21) had recurrent infection, 9.8% (n=10) had non-union, and 4.9% (n=5) required an amputation. The mean age at injury was 49.71 years old. Regarding cardiovascular risk factors, 37 patients were current smokers (36.3%), 31 patients were diabetics (30.4%), and 32 patients (31.4%) were obese (BMI≥30.0). Average follow-up time was 2.37 (range: 1.04-5.14) years. Risk factors for FRI treatment failure were BMI>30, GA type 3c, and implant retention. Given that FRI treatment in 35.3% (36/102) ended up in failure, clinicians need to take into account the predictive variables analysed in this study, and implement a multidisciplinary team approach to optimise these factors. This study could aid clinicians to redirect efforts to improve high risk patient management, and prompt future studies to trial adjuvant technologies for patients at higher risk of failure

Aims

The influence of metabolic syndrome (MetS) on the outcome after hip and knee arthroplasty is debated. We aimed to investigate the change in patient-reported outcome measure (PROM) scores after hip and knee arthroplasty, comparing patients with and without MetS.

Aims. Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees. Methods. A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed. Results. There were 22 periprosthetic fractures; they occurred exclusively in the femur: two in the femoral neck, 14 intertrochanteric and six subtrochanteric, representing 4.2% of 518 osseointegration operations and 6.3% of 347 femoral implants. The vast majority (19/22, 86.4%) occurred within 2 cm of the proximal tip of the implant and after a fall. No fractures occurred spontaneously. Fixation most commonly involved dynamic hip screws (10) and reconstruction plates (9). No osseointegration implants required removal, the K-level was not reduced after fixation of the fracture in any patient, and all retained a K-level of ≥ 2. All fractures united, 21 out of 22 patients (95.5%) wear their osseointegration-mounted prosthetic limb longer daily than when using a socket, with 18 out of 22 (81.8%) reporting using it for ≥ 16 hours daily. Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046). No increased risk was identified for bilateral implants (p = 0.083), time from amputation to osseointegration (p = 0.974), age at osseointegration (p = 0.331), or bone density (g/cm2, p = 0.560; T-score, p = 0.247; Z-score, p = 0.312). Conclusion. The risks and sequelae of periprosthetic fracture after press-fit osseointegration for amputation should not deter patients or clinicians from considering this procedure. Females and heavier patients are likely to have an increased risk of fracture. Age, years since amputation, and bone density do not appear influential. Cite this article: Bone Joint J 2020;102-B(2):162–169

Background. The ability to identify those at risk for longer inpatient stay helps providers with postoperative planning and patient expectations. Decreasing length of stay in the future will be determined by appropriate patient selection, risk stratification, and pre-operative patient optimization. The purpose of this study was to identify factors that place patients at risk for extended postoperative lengths of stay. Methods. The prospective study cohort included 2009 primary total knee arthroplasty (TKA) patients and 905 total hip arthroplasty (THA) patients. Patient comorbidities were prospectively identified and the length of stay for each patient was tracked following a primary arthroplasty. Statistical analysis was performed to correlate which comorbidities were associated with longer inpatient stays. Results. In the TKA population, gender, smoking status, venous thromboembolism history, body mass index and diabetes status were not found to be a significant predictors for length of stay. Age was found to be a factor in univariate regression testing (P<0.001). In the THA population, univariate testing showed female gender (P<0.001), smoking status (P=0.002), and age (p<0.001) to be factors, but like the TKA population venous thromboembolism history or diabetes status were not significant. In THA multivariate analysis, age (p<0.001) and female gender (p=0.018) continued to be factors, but smoking was determined to be a confounding variable. Conclusions. Age and gender were associated with a longer length of stay after THA, whereas only age was a significant factor after TKA. Development of age adjusted LOS models may help aid patient expectations and risk management

Aims

With the ageing population, fragility fractures have become one of the most common conditions. The objective of this study was to investigate whether microbiological outcomes and fracture-healing in osteoporotic bone is worse than normal bone with fracture-related infection (FRI).

The ATTUNE™ Knee System (DePuy Synthes) comprises of a tibial insert that is made from AOX™, an antioxidant-stabilized polyethylene. The antioxidant used in AOX is pentaerythritol tetrakis [3-(3, 5-di-tertiary butyl-4-hydroxyphenyl)] propionate (PBHP). A biological risk assessment of the degradation products arising from PBHP has been performed. This assessment focuses on the requirements of ISO 10993–1:2009, ISO 14971:2007, and the Medical Device Directive 93/42/EEC. Because the orthopedic implant is a permanent implant, consideration has been given to all relevant endpoints defined by ISO 10993–1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Comprehensive biocompatibility testing including long-term (26 weeks) subcutaneous implantation has been conducted which confirms the biosafety of the polyethylene compound[1]. In addition to the biological safety testing completed, the overall safety and the associated toxicological risk of exposure to degradation products of PBHP has been given due consideration. The guidelines for the Threshold for Toxicological Concern (TTC) provided by The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group were used in the assessment[2]. This working group is a collaboration of chemists and toxicologists from the U.S. Food and Drug Administration (FDA), industry, and academia. The TTC principle allows safety assessment in the absence of substance-specific hazard data, based on very low levels of exposure to that substance. A Margin of Safety (MOS) is calculated as the ratio of the threshold safety value to the actual exposure quantities determined and used in the assessment. A MOS value greater than 1 is typically judged by risk assessors and regulatory bodies to be unlikely to cause harm and the risk may be considered low. The identity of the degradation products as well as the corresponding 30-day leachable quantities from a water:acetone extraction media has been previously reported [3] and provided here (Table 1). The amount of leachables determined from Table 1 for all products were well below the TTC of 150 ng/device and hence no toxicological risks were identified for these compounds. In order to further examine the toxicological risk assessment, aggressive extraction using Dynamic Head Space (DHS) extraction was done and analytical testing was performed on the degradation products of PBHP using gas chromatography/mass spectrometry (GC /MS). These estimated quantities along with literature information from biological safety studies of the chemicals that were identified from the quantitative GC/MS analysis of degradation products of PBHP were used in the review and toxicological assessment per the methodology described in ISO 14971 and ISO 10993–18. The extraction and analysis confirmed the same sixteen compounds previously identified. The quantities and the calculated margins of safety are summarized (Table 2). In conclusion, upon review of actual test results of PBHP degradation products (Table 1), there is little probability that these organic degradation products would cause a systemic reaction and not be safe. Thus, the potential biological hazards identified in ISO 10993–1:2009 due to the quantified leachables have been verified to be minimal with a high Margin of Safety relative to the Threshold of Toxicological Concern

Aims

Displaced distal radius fractures were investigated at a level 1 major trauma centre during the COVID-19 2020 lockdown due to the implementation of temporary changes in practice. The primary aim was to establish if follow-up at one week in place of the 72-hour British Orthopaedic Association Standards for Trauma & Orthopaedics (BOAST) guidance was safe following manipulation under anaesthetic. A parallel adaptation during lockdown was the non-expectation of Bier’s block. The secondary aim was to compare clinical outcomes with respect to block type.

This fiducial role implies special duties imposed where one person (the fiduciary) must act in the best interest of the other (the beneficiary), even if it is in the fiduciary's detriment to do so. While a doctor/patient relationship is not generally a fiduciary relationship, part of the relationship may involve a fiduciary role for the surgeon. The fiduciary duties include:. Keeping a patient's medical information confidential. Open disclosure of surgical error. Notification of an emergent medical risk to the patient. Avoiding gifts from patients not freely given. Avoiding conflict of interest in implant selection. Disclosing financial involvement with healthcare facility. Candour when a known risk has materialised. E.g. implant failure. Share crucial information with patients to mitigate potential harm. Follow up until the treatment period is over with relevant information. Limit therapeutic privilege as grounds for non-disclosure. Follow the Association's guidelines on product endorsement. New procedures may require ethics approved clinical trials. Avoid personal relationships with patients. While the doctor–patient relationship requires a duty of care, a fiduciary duty implies a duty of loyalty and honesty. As per using navigation techniques in hip and knee surgery, the surgeon can use the above fiducials (markers) to navigate his way through his fiduciary role in managing patients; whether it is disclosing emergent risks arising during treatment, with new products or during clinical trials. Fiduciary roles are independent of informed consent, which occurs before the event, but mitigate a risk that occurs after the event. It is an inbuilt quality assurance mechanism in risk management

Background: It remains unclear and controversial whether preoperative magnetic resonance imaging (MRI) in patients with adolescent idiopathic scoliosis (AIS) should be mandatory. Aim: (1) To review our own practice, (2) conduct a national survey of United Kingdom Consultants, and (3) to perform a literature review. Methods: Our own practice was established by identifying patients with AIS and examining whether an MRI scan was performed preoperatively. A survey of Consultants practice in the UK (British Scoliosis Members) was conducted by either an e-mail or telephone conversation. Finally, a literature survey was performed to establish current views. Results: 118 patients with AIS were identified between 2003 and 2007. 78% of these patients underwent pre-operative MRI scans. Neural axis abnormalities were found in 8% of these patients. They included syrinx’s, chiari malformations, tonsillar herniation, cord tethering, central canal dilatation and undiagnosed spina bifida. Only 1 patient required intervention by the neurosurgeons. 92% of respondents to the national survey routinely performed preoperative MRI scans. The literature was not conclusive with regards to mandatory preoperative imaging. Conclusion: Despite the literature showing little evidence, our survey shows a widespread consensus in clinical practice across the UK that routine preoperative MRI should be performed from a risk management viewpoint. It is mandatory in our unit to perform pre-operative MRI scans on all patients with AIS and would recommend that this becomes standard practice in all other units. Ethics Approval: None/Audit. Interest Statement: None

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 negligence claims made against NHS bodies in England. In addition to dealing with claims when they arise, there is an active risk management programme to help raise standards of care in the NHS and hence reduce the number of incidents leading to claims. By analysing the claims data, we have had the opportunity to see trends for which Trusts have litigation brought against them, how much this costs the Health Service and most importantly how this information can aid in clinical practice. Between 1995 until 2005/06 there were 408 cases involving orthopaedics in England that had reached a conclusion. Of those considered in our study (341), by far the most common broad category for litigation is missed or delayed diagnosis of a condition 179 cases (57% of all litigation cases) with 44% (80 cases) of those being upper limb traumatic injuries. Humeral supracondylar fractures and elbow injuries constitute 24% (44 cases) of all missed diagnoses with each having an average total payout of £27,998. Missed or poorly managed developmental disorders of the hip (DDH or SUFE) also have large total payouts. Other common causes for litigation are intra-operative errors with poor results/complications for fixation of humeral supracondylar fractures again being the most common. Complications of plasters also represent 7.3% of all claims, all with high total payouts. In assessing these trends, we suggest highlighting the potential for error during training of juniors and taking extra care during clinical practice. There are also implications identified for the planned provision of Orthopaedic care of children

Purpose: Litigation continues to be a concern in orthopaedic surgery despite suggestions on how to contain liability. The purpose of this study was to characterize orthopaedic litigation in Canada from 1997–2006. Method: This study reviewed all closed claims reported to the Canadian Medical Protective Association (CMPA) for 1997–2006 in which orthopaedic surgeons were named. There were 11,983 closed legal actions involving CMPA members (> 73,000 physicians), and 1,353 involved orthopaedic surgeons. A careful review of closed legal actions is a recognized tool for risk identification, assessment and management. The CMPA identifies any critical incidents within the closed legal files. A critical incident is defined as any omission or commission in the evaluation or management which led to the problem(s) that triggered the legal action. Each closed legal action can have more than one critical incident. Results: Performance, diagnostic and communication issues were the most frequently identified problems. These three areas account for 55% of the critical incidents identified. Performance related issues accounted for 395 critical incidents (29%). Diagnostic issues, including deficient histories and general evaluations, were identified in 281 cases (21%). Communication-related critical incidents included those concerning informed consent. The lack of informed consent was a common allegation, proven in 71 cases. In 439 cases (32%) there was no identifiable critical incident for the orthopaedic surgeon involved. Seventy-eight per cent of patients experienced minor or no disability and 22% experienced major disability or death. Events related to tibia trauma and knee arthroscopy formed the two major categories of claims. Patient care areas of high risk include the operating room and outpatient clinic. Overall, 31% of legal actions against orthopaedic surgeons had outcomes in favour of the plaintiffs, compared with 33% of all CMPA members’ claims. Conclusion: Although the likelihood for an orthopaedic surgeon to be sued in Canada has decreased over the last 10 years, the percentage of legal cases resolved in favour of plaintiffs has remained stable. Performance-related deficiencies, delays in diagnosis, and failures in communication represent areas of high medico-legal risk. Suggestions for risk management are provided to further decrease adverse events and the medico-legal risks for Canadian orthopaedic surgeons

Introduction Dedicated software has been developed to allow computerised pre-operative planning for joint replacements where digital x-rays of known magnification are placed on a computer screen and templates are matched to produce an accurate plan. Improving efficiency, reducing error and improving patient outcomes are the goals. Methods Two methods for determining magnification of x-rays have been considered. 1: a metal marker of known size is placed on the limb in the same plane as the joint and the software matches the template to the x-ray. Several problems arise including unrecognizable markers in the obese or when taking full pelvis x-ray. 2: a computer tomogram scout film provides a digital format, accurate magnification, a film of adequate quality and the capacity to plan on the normal hip in unilateral disease. The new software was developed using digital radiology to provide; certainty of patient identification, tools for measurement, tools for drawing and to allow linear and angular movement of components of the image. Risk management was undertaken. Data concerning component details completed the program. Results The phase one trial demonstrated that the tool achieved the goals set. A digital image could be matched to implant component data. The tools allowed; measurement of relevant anatomy, consideration of leg length difference, and angular deformity, identification of landmarks such as center of rotation of the socket and offset, and comparison between the normal and pathological sides. Components could be chosen and errors detected, such as incompatible components or wrong side, and an order generated for forwarding to the supplier. Choice of stem was always within one size of pre-operative templating. Choice of socket was within two sizes. Conclusions The explanation for discrepancy may be the intra-operative desire to judge size according to “feel” at surgery. A surgeon may wish to demonstrate accuracy by “forcing” intra-operative decision towards verifying pre-operative planning. What is surprisingly is that surgeons do not have uniform views as to the “ideal” socket position or stem position. In relation to the conduct of this study, one or more the authors have received, or are likely to receive direct material benefits

Per definition we distinguish between shaft fractures of the tibia and fibula (lower leg), proximal tibial fractures, distal tibial fractures and isolated tibial shaft fractures. There are different criteria to classify a tibial fracture: 1. age, 2. soft tissue damage. Not only the terms, “open” and, “closed” but also coexistent neurovascular damage and the presence of a compartment syndrome have to be mentioned. 3. Furthermore there are well known anatomical classifications of tibial fractures (AO, OTA). Special conditions, as osteoporosis, osteopenia, pathological fractures and osteogenesis imperfecta have to be recognized. The optimal treatment concept depends on the correct diagnosis, the manifestation of priorities, calculation of risks, management of complications and rehabilitation. The treatment options of severe tibial fractures are: The interlocking nail in reamed or unreamed technique, the external fixator and in very rare cases plating or screw fixation. The following principles in the treatment of severe tibial fractures should be mentioned:. The method of choice in closed and I° open tibial fractures is the reamed intramedullary nailing. If there is a coexistent fibular fracture at the same level as the tibial fracture, plating of the fibula should be performed. The preferred method in closed tibial fractures with moderate soft tissue damage and in II° open tibial fractures is the unreamed interlocking nailing. The closed tibial fracture with severe soft tissue damage as well as the III° open fracture are preferable treated by external fixation. The changing to intamedullary stabilization should be included in the therapeutic plan, primarily, or should be indicated later on. Plating (ORIF) of severe tibial fractures has become a very rare performed procedure and is presently done just in some special exemptions. A complementary osteo-synthesis, including nailing and plating, is not included in our therapeutic concept. Proximal and distal tibial fractures involving the joint surface are not included in this consideration. The indication for fasciotomy must not be too restrictive. A compartment syndrome should not prevent intramedullary nailing and a standardized protocol for second look procedures to protect bone and soft tissue has to be made. In children the method of choice in severe tibial fractures is the external fixation The own experiences, during a three year period (1999–2001), including 208 tibial/ fibular shaft fractures are presented. We had 77% closed and 23% open fractures. Overall 90% were treated by intramedullary nailing. In the open fractures, we fixed all I° open fractures by nailing and 56% of the II° open fractures. 67% of III°a fractures, 90% of III°b and all III°c fractures were initially stabilized by external fixation

Aims

Slipped capital femoral epiphysis (SCFE) is one of the most common hip diseases of adolescence that can cause marked disability, yet there is little robust evidence to guide treatment. Fundamental aspects of the disease, such as frequency, are unknown and consequently the desire of clinicians to undertake robust intervention studies is somewhat prohibited by a lack of fundamental knowledge.

Introduction

There is widespread variation in the management of rare orthopaedic disease, in a large part owing to uncertainty. No individual surgeon or hospital is typically equipped to amass sufficient numbers of cases to draw robust conclusions from the information available to them. The programme of research will establish the British Orthopaedic Surgery Surveillance (BOSS) Study; a nationwide reporting structure for rare disease in orthopaedic surgery.

Aims

Intraoperative 3D navigation (ION) allows high accuracy to be achieved in spinal surgery, but poor workflow has prevented its widespread uptake. The technical demands on ION when used in patients with adolescent idiopathic scoliosis (AIS) are higher than for other more established indications. Lean principles have been applied to industry and to health care with good effects. While ensuring optimal accuracy of instrumentation and safety, the implementation of ION and its associated productivity was evaluated in this study for AIS surgery in order to enhance the workflow of this technique. The aim was to optimize the use of ION by the application of lean principles in AIS surgery.