Aims. Describe a statistical and
The aim of this study was to perform the first population-based description of the epidemiological and health economic burden of fracture-related infection (FRI). This is a retrospective cohort study of operatively managed orthopaedic trauma patients from 1 January 2007 to 31 December 2016, performed in Queensland, Australia. Record linkage was used to develop a person-centric, population-based dataset incorporating routinely collected administrative, clinical, and health economic information. The FRI group consisted of patients with International Classification of Disease 10th Revision diagnosis codes for deep infection associated with an implanted device within two years following surgery, while all others were deemed not infected. Demographic and clinical variables, as well as healthcare utilization costs, were compared.Aims
Methods
Open lower limb fractures are resource-intensive fractures, accounting for a significant proportion of the workload and cost of orthopaedic trauma units. A recent study has evaluated that the median cost of direct inpatient treatment of open lower-limb fractures in the National Health Service (NHS) is steep, at £19189 per patient. Healthcare providers are expected to be aware of the costs of treatments, although there is very limited dissemination of this information, neither on a national or local level. Older adults (>65 years old) are at an increased risk of the types of high-energy injuries that can result in open lower limb fractures. Generally, there remains a significant lack of literature surrounding the cost of open fracture management, especially in specific patient groups that are disproportionately affected by these fractures. This study has calculated the direct inpatient care costs of older adults with open lower limb fractures. Open lower limb fractures in adult patients over 65 years old treated at Addenbrooke's Hospital of Cambridge University Hospitals NHS Trust were identified over the period of March 2014-March 2019. Isolated fractures of the femur, tibia and fibula over this time period were included. Direct inpatient care costs were calculated using information about the sustained fracture, operative time, implant(s) and theatre kit(s) used, the number of patient bed-days on the orthopaedic ward and critical care unit, and the number of hours of inpatient physiotherapy received. Direct inpatient care costs were compared with the income received by our centre for each of these cases, according to Healthcare Resource Group (HRG) cost codes. Our data was also compared with existing literature on Patient Level Costing (PLC) figures for open lower limb fractures. We extracted data from 58 patients over the age of 65 years treated for open isolated lower limb fractures at Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, between March 2014 and March 2019. The median cost of inpatient care calculated in this study was £20,398 per patient, resulting in a financial loss to the hospital of £5113 per patient. When the results were disaggregated by sex, the median cost for an open lower limb fracture in a male patient was £20,886 compared to £19,304 in a female patient. Data were also disaggregated by the site of injury, which produced a median cost for an open femur fracture of £23,949, and £24,549 and £15,362 for open tibia and ankle fractures, respectively. The absence of published primary literature and clinical audits on this topic continues to hinder the inclusion of cost-effectiveness as an important factor in clinical decision-making. This study provides valuable insight into the true cost of open lower limb fractures in a key patient population in a Major Trauma Centre in England and highlights the large losses incurred by hospitals in treating these cases. These results support the revision of the remuneration structures in the NHS for the treatment of elderly patients with these injuries.
Purpose. There is increasing evidence that primary fixation of displaced mid-shaft fractures of the clavicle results in superior short-term outcomes when compared to traditional non-operative methods. However, the results from published studies are limited to relatively short-term (one year or less) follow-up. Accurate data of longer follow-up is important for a number of reasons, including patient prognostication, counseling and care, the design of future trials, and the
Using current analysis/methodology, new implant technology is unlikely to demonstrate a large enough change in patient function to impact on the cost-effectiveness of the procedure. Cost effectiveness is an increasingly important metric in today's healthcare environment, and decisions surrounding which arthroplasty prosthesis to implant are not exempt from such health economic concerns. Quality adjusted life years (QALYs) are the typical assessment tool for this type of evaluation. Using this methodology, joint arthroplasty has been shown to be cost effective, however studies directly comparing the QALY achieved by differing prostheses are lacking.Summary Statement
Purpose
Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.Aims
Methods
The introduction of new treatments needs to be both clinically effective and cost effective. Clinicians tend to be unaware of the importance of the latter, and how health economic assessments are undertaken, especially in a public health system where the inclusion of funded treatments is made on a national basis. The purpose of this study was to determine the cost savings from a societal perspective in the use of recombinant human Bone Morphogenetic Protein -2 (rhBMP-2) in grade III A and B open tibia fractures treated with a locked intramedullary nail and soft-tissue management in the UK, Germany, and France. Healthcare system (direct healthcare costs) and costs for productivity losses (indirect health-care costs) were calculated using the raw data from the Bone Morphogenetic Protein Evaluation Group in Surgery for Tibial Trauma “BESTT study”. Return-to-work time for estimation of productivity losses was assumed to correspond with the time of fracture healing. For calculation of secondary interventions costs and productivity losses the respective 2007/08 national tariffs for surgical procedures and average national wages for the UK, Germany, and France were used. From a societal perspective, overall savings per case of €7911 for the UK, €9270 for Germany, and €9291 were calculated. Those savings largely offset the upfront price of rhBMP-2 of €2266(£1,790) in the UK, €2970 in Germany, and €2950 in France. Total net savings can be estimated to be €9.6 million for the UK, €14.5 million for Germany, and €11.4 million for France. For all three countries reduced productivity losses are the key driver for the overall savings. In summary, despite the apparent high direct cost of rhBMP-2 in grade III A and B open tibia fractures, at a national level there are net cost-savings from a societal perspective for all three countries.
The ability to calculate quality-adjusted life-years (QALYs) for degenerative cervical myelopathy (DCM) would enhance treatment decision making and facilitate
Aims. It is unclear if a supportive bandage, removable splint, or walking cast offers the best outcome following low-risk ankle fractures in children. The aim of this study was to evaluate the feasibility of a randomized controlled trial to compare these treatments. Methods. Children aged five to 15 years with low-risk ankle fractures were recruited to this feasibility trial from 1 February 2020 to 30 March 2023. Children were randomized to supportive bandage, removable splint, or walking cast for two weeks. Follow-up at two, six, and 12 weeks was undertaken to determine feasibility for a definitive trial. Outcomes collected included complications, the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility score, Paediatric Quality of Life Inventory, youth version of the EuroQol five-dimension health questionnaire, and Activities Scale for Kids - Performance. Results. A total of 87 children from six hospitals were randomized at a rate of 0.9 participants per site per month. Two children in the supportive bandage group crossed over to an alternative device. Complications were reported in six children. One child in the cast group developed skin blisters. One child in cast and one in bandage sustained a reinjury during the 12-week follow-up, and two children (one splint and one cast) required additional immobilization after the two-week treatment for persistent pain. Of the 84 participants who remained in the study at six weeks, 43 (51.2%) returned follow-up questionnaires at six weeks. Of the patient-reported outcome measures (PROMs), proxy-reported PROMIS mobility showed good responsiveness, low ceiling effects, and low missing item rates. In an exploratory analysis, small differences were observed between groups, with no evidence that any of the treatments were superior. Conclusion. This feasibility study showed acceptable recruitment and retention rates. There remains equipoise regarding the best treatment of these injuries. All three treatments appear well tolerated with similar complication rates. A primary outcome of complications or treatment failure would provide the highest study retention with secondary PROMs and
Aims. Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. Methods. This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel
Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021). Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings. The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training. We conclude that a full RCT with
Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an
Purpose and background. To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. Methods and results. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health
Abstract. Introduction. This multi-centre randomised controlled trial evaluated the clinical and cost effectiveness of liposomal bupivacaine for pain and recovery following knee replacement. Methodology. 533patients undergoing primary knee replacement were randomised to receive either liposomal bupivacaine (266mg) plus bupivacaine hydrochloride (100mg) or control (bupivacaine hydrochloride 100mg), administered at the surgical site. The co-primary outcomes were pain visual analogue score (VAS) area under the curve (AUC) 6 to 72hours and the Quality of Recovery 40 (QoR-40) score at 72hours. Results. Primary analysis found no difference in pain VAS AUC 6 to 72hours between liposomal bupivacaine and control (MD -21.5 (97.5% CI -46.8 to 3.8; p=0.057)), nor the QoR-40 at 72hours (MD 0.54, 97.5% CI -2.05 to 3.13, p=0.643). Analyses of pain VAS and QoR-40 scores on days 0, 1, 2 and 3 demonstrated only one significant difference, with the liposomal bupivacaine arm having lower pain scores the evening of surgery (day0; MD -0.54, 97.5% CI -1.07 to -0.02; p=0.021). No difference in cumulative opioid consumption or functional outcome at 6weeks, 6months or 1year was detected. Heath
Robotic and navigated TKA procedures have been introduced to improve component placement precision for the purpose of improving implant survivorship and other clinical outcomes. Although numerous studies have shown enhanced precision in placing components, adoption of technology-assistance (TA) for TKA has been relatively slow. One reason for this has been the difficulty in demonstrating the cost-effectiveness of implementing TA-TKA systems and assessing their impact on revision rates. In this study, we aimed to use a simulation approach to answer the following questions: (1) Can we determine the distribution of likely reductions in TKA revision rates attributable to TA-TKA in an average US patient population? And, (2) What reduction in TKA revision rates are required to achieve economic neutrality?. In a previous study, we developed a method for creating large sets of simulated TKA patient populations with distributions of patient-specific factors (age at index surgery, sex, BMI) and one surgeon-controlled factor (coronal alignment) drawn from registry data and published literature. Effect sizes of each factor on implant survival was modeled using large clinical studies. For 10,000 simulated TKA patients, we simulated 20,000 TKA surgeries, evenly split between groups representing coronal alignment precisions reported for manual (±3°) and TA-TKA (±1.0°), calculating the patient-specific survival curve for each group. Extending our previous study, we incorporated the probability of each patient's expected survival into our model using publicly available actuarial data. This allowed us to calculate a patient-specific estimate of the Reduction in Lifetime Risk of Revision (RLRR) for each simulated patient. Our analysis showed that 90% of patients will achieve an RLRRof 1.5% or less in an average US TKA population. We then conducted a simplified
Background. There are advantages and disadvantages of Unicompartmental (UKR) and Total Knee Replacement, with UKR having better functional outcomes with fewer complications but a higher revision rate. The relative merits depend on patient characteristics. The aim was to compare UKR and TKR risk-benefits and cost-effectiveness in patients with severe systemic morbidity. Methods. Data from the National Joint Registry for England, Wales and Northern Ireland was linked to hospital inpatient and patient-reported outcomes data. Patients with American Society of Anesthesiologists (ASA) grade ≥3 undergoing UKR or TKR were identified. Propensity score stratification was used to compare 90-day complications and 5-year revision and mortality of 2,256 UKR and 57,682 TKR, and in a subset of 145 UKR and 23,344 TKR Oxford Knee Scores (OKS). A health-economic analysis was based on EQ-5D and NHS hospital costs. Results. The OKS was significantly better following UKR than TKR with a difference of 1.83 (95%CI 0.10–3.56). UKR was associated with lower relative risks of venous thromboembolism (0.33, CI0.15–0.74), myocardial infarction (0.73, CI0.36–1.45) and early joint infection (0.85, CI0.33–2.19) but only the decrease in venous thromboembolism was significant. The revision risk following UKR was significantly higher than following TKR (hazard ratio 2.70, CI2.15–3.38) and the mortality was significantly lower (0.52, CI0.36–0.74). At five years the cumulative incidence of revision was 8% higher with UKR, and the cumulative incidence of death was 13% lower. The health
Introduction. Total knee arthroplasty is a highly effective procedure to improve the quality of life in patients with advanced osteoarthritis. The number of these procedures are expected to grow 174% by 2030. This growth rate is expected to economically strain the health care system. A potential solution to alleviate this problem is the utilization of single use instruments (SUI). Potential advantages of SUI include: improved operating room efficiencies, decreased costs associated with traditional instrument management (sterile processing, shipping), and decreased infection risk. The present study examines the clinical results of SUI compared to standard instrumentation. Furthermore, economic modeling is performed to examine the cost savings that is potentially realized with their use. Materials and Methods. 51 patients receiving a TKA with use of SUI were prospectively compared to 49 patients utilizing standard instrumentation. Knee Society Scores and Radiographic alignment will be evaluated. Adverse events will be recorded. Economic modeling of SUI will be performed in 4 different areas: 1. Decreased infection burden; 2. Operating room logistics; 3. Sterile processing savings; and 4. Instrument logistical savings. Results. The average Pre-operative KSS (Objective/Functional) scores were 48.7/41.6 for the SIU patients compared to 50.2/38.7 for the standard instrumentation patients. Post-operative improvements measured 84.0/72.8 and 83.9/76.4 for the 2 groups respectively. The Pre-operative Hip-Knee-Ankle Angle was 176.2 and 177.0 for the 2 groups. The SUI HKA improved to 179.3 while the standard improved to 178.9. There were no statistical differences between the 2 groups. Furthermore, there were no cases of subsidence, migration, loosening, or infection in either group. There were no SUI procedure abandonments.
There is ongoing debate regarding the optimal surgical treatment of complex proximal humeral fractures in elderly patients. The aim of this study was to evaluate the cost-effectiveness of reverse total shoulder arthroplasty (RTSA) compared to hemiarthroplasty (HA) in the management of these fractures. A cost–utility analysis using decision tree and Markov modelling based on data from the published literature was conducted. A single-payer perspective with a lifetime time horizon was adopted. A willingness to pay threshold of CAD $50,000 was used. The incremental cost-effectiveness ratio (ICER) was used as the study's primary outcome measure. In comparison to HA, the incremental cost per QALY gained for RTSA was $13,679. One-way sensitivity analysis revealed the model to be sensitive to the RTSA implant cost and the RTSA procedural costs. Two-way sensitivity analysis suggested RTSA could also be cost-effective within the first two years of surgery with an early complication rate as high as 25% (if RTSA implant cost was approximately $3,000); or conversely, RTSA implant cost could be as high as $8,500 if its early complication rates were 5%. The ICER of $13,679 is well below the WTP threshold of $50,000 and probabilistic sensitivity analysis demonstrated that 92.6% of model simulations favoured RTSA. Our
