Association between the Orthopaedic Trauma Society classification of open fractures and economic costs.

AIMS: The aim of this study was to investigate the relationship between the Orthopaedic Trauma Society (OTS) classification of open fractures and economic costs. METHODS: Resource use was measured during the six months that followed open fractures of the lower limb in 748 adults recruited as part of two large clinical trials within the UK Major Trauma Research Network. Resource inputs were valued using unit costs drawn from primary and secondary sources. Economic costs (GBP sterling, 2017 to 2018 prices), estimated from both a NHS and Personal Social Services (PSS) perspective, were related to the degree of complexity of the open fracture based on the OTS classification. RESULTS: Adjusted mean total NHS and PSS costs were £13,785 following treatment of complex fractures and £3,550 following treatment of simple fractures, where the open fracture wound is closed at the end of the first wound debridement, generating a mean difference of £10,235 (95% confidence interval £8,074 to £12,396). CONCLUSION: Following previous work correlating clinical outcomes with the OTS classification of open fractures, this study suggests that the new OTS classification also correlates with economic costs estimated from alternative study perspectives. Cite this article: Bone Joint J 2022;104-B(3):408-412.

Complications and its impact in patients with closed and open tibial shaft fractures requiring open reduction and internal fixation.

Aim: To evaluate the rates of infection and nonunion and determine the impact of infections on healthcare resource use and costs following open and closed fractures of the tibial shaft requiring open reduction internal fixation. Methods: Healthcare use and costs were compared between patients with and without infections following pen reduction internal fixation using MarketScan® databases. Results: For commercial patients, the rates of infection and nonunion ranged from 1.82 to 7.44% and 0.48 to 8.75%, respectively, over the 2-year period. Patients with infection had significantly higher rates of hospital readmissions, emergency room visits and healthcare costs compared with patients without infection. Conclusion: This real-world study showed an increasing rate of infection up to 2 years and infection significantly increased healthcare resource use and costs.

Cost-effectiveness of negative-pressure wound therapy in adults with severe open fractures of the lower limb: evidence from the WOLLF randomized controlled trial.

AIMS: The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb. PATIENTS AND METHODS: An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation. RESULTS: The base case analysis produced an incremental cost-effectiveness ratio of £267 910 per QALY gained, reflecting higher costs on average (£678; 95% confidence interval (CI) -£1082 to £2438) and only marginally higher QALYS (0.002; 95% CI -0.054 to 0.059) in the NPWT group. The probability that NPWT is cost-effective in this patient population did not exceed 27% regardless of the value of the cost-effectiveness threshold. This result remained robust to several sensitivity and subgroup analyses. CONCLUSION: This trial-based economic evaluation suggests that NPWT is unlikely to be a cost-effective strategy for improving outcomes in adult patients with severe open fractures of the lower limb. Cite this article: Bone Joint J 2019;101-B:1392-1401.

Economic outcomes associated with deep surgical site infection in patients with an open fracture of the lower limb.

AIMS: The aim of this study was to estimate economic outcomes associated with deep surgical site infection (SSI) in patients with an open fracture of the lower limb. PATIENTS AND METHODS: A total of 460 patients were recruited from 24 specialist trauma hospitals in the United Kingdom Major Trauma Network. Preference-based health-related quality-of-life outcomes, assessed using the EuroQol EQ-5D-3L and the 6-Item Short-Form Health Survey questionnaire (SF-6D), and economic costs (£, 2014/2015 prices) were measured using participant-completed questionnaires over the 12 months following injury. Descriptive statistics and multivariate regression analysis were used to explore the relationship between deep SSI and health utility scores, quality-adjusted life-years (QALYs), and health and personal social service (PSS) costs. RESULTS: Deep SSI was associated with lower EQ-5D-3L derived QALYs (adjusted mean difference -0.102, 95% confidence interval (CI) -0.202 to 0.001, p = 0.047) and increased health and social care costs (adjusted mean difference £1950; 95% CI £1383 to £5285, p = 0.250) versus patients without deep SSI over the 12 months following injury. CONCLUSION: Deep SSI may lead to significantly impaired health-related quality of life and increased economic costs. Our economic estimates can be used to inform clinical and budgetary service planning and can act as reference data for future economic evaluations of preventive or treatment interventions. Cite this article: Bone Joint J 2018;100-B:1506-10.

Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb-a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST).

INTRODUCTION: Patients with closed high-energy injuries associated with major trauma have surprisingly high rates of surgical site infection in incisions created during fracture fixation. One factor that may reduce the risk of surgical site infection is the type of dressing applied over the closed surgical incision. In this multicentre randomised clinical trial, negative-pressure wound therapy will be compared with standard dressings with outcomes of deep infection, quality of life, pain and disability. METHODS AND ANALYSIS: Adult patients presenting to hospital within 72 hours of sustaining major trauma, requiring a surgical incision to treat a fractured lower limb, are eligible for inclusion. Randomisation, stratified by trial centre, open/closed fracture at presentation and Injury Severity Score (ISS) ≤15 versus ISS ≥16 will be administered via a secure web-based service using minimisation. The random allocation will be to either standard wound management or negative-pressure wound therapy.Trial participants will usually have clinical follow-up at the local fracture clinic for a minimum of 6 months, as per standard National Health Service practice. Diagnosis of deep infection will be recorded at 30 days. Functional, pain and quality of life outcome data will be collected using the Disability Rating Index, Douleur Neuropathique Questionnaire and Euroqol - 5 Dimension - 5 level (EQ-5D-5L) questionnaires at 3 months and 6 months postinjury. Further data will be captured on resource use and any late postoperative complications.Longer term outcomes will be assessed annually for 5 years and reported separately. ETHICS AND DISSEMINATION: National Research Ethics Committee approved this study on 16 February 2016 16/WM/0006.The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of this trial. The results of this trial will inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. TRIAL REGISTRATION NUMBER: ISRCTN12702354; Pre-results.

A representative assessment of the management of open fractures of the lower limb within UK orthoplastic centres: A two-centre audit of compliance with national standards.

BACKGROUND: Open fractures of the lower limb represent a complex and varied array of injuries. The BOAST 4 document produced by BAPRAS and the BOA provides standards on how to manage these patients, and NICE have recently produced additional guidance. We aimed to assess concordance with these standards in a large cohort representative of UK orthoplastic centres. METHODS: Patients admitted to the orthoplastic units at Norfolk and Norwich University Hospital and Royal Stoke University Hospital with open lower limb fractures between 2009 and 2014 were included. Data was gathered from notes and endpoints based on the BOAST 4 document. RESULTS: In total, 84 patients were included across the two sites, with 83 having their initial debridement within 24h (98.8%). Forty-two patients had a documented out-of-hours initial surgery. Of these, 10 (23.8%) had an indication for urgent surgery. This pattern was consistent across both hospitals. A plastic surgeon was present at 33.3% of initial operations. Of 78 patients receiving definitive soft tissue cover, 56.4% had cover within 72h and 78.2% within 7days. Main reasons for missing these targets were transfer from other hospitals, plastic surgeons not present at initial operation and intervening critical illness. CONCLUSIONS: This study has identified key areas for improving compliance with the national BOAST 4 and NICE standards. Out-of-hours operating is occurring unnecessarily and time targets are being missed. The development of dedicated referral pathways and a true orthoplastic approach are required to improve the management of this complex set of injuries.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Open lower limb fractures in Major Trauma Centers - A loss leader?

PURPOSE: Open lower limb fractures are resource intensive injuries. Regardless of the financing model, the cost of treatment is an important consideration for any healthcare provider. METHODS: Open lower limb fractures treated at our centre were identified over a six-month period. Isolated open femur or tibia fractures were included as well as cases with multiple fractures. Direct inpatient care costs were calculated and income was reviewed for each case according to 'Healthcare Resource Group' (HRG) cost codes. RESULTS: A total of 41 open lower limb fractures (32 patients) were identified. There were isolated open fractures in twenty-five and multiple lower limb open fractures in seven patients. Twenty-three patients (72%) were male and nine were female (28%) with an average age of 40 years (range 10-89 years). The fractures were classified according to Gustilo and Anderson (GA) and divided into two main groups; there were 13 mild and 28 severe open fractures. The median direct cost of inpatient treatment for open lower limb fractures was £19,189 per patient. There was a net gain of £6,288 per fracture in the mild group and a loss of £7,582 in the severe group. The total deficit was £149,545 over the six-month period for this cohort of 41 fractures. CONCLUSION: Open lower limb fractures are expensive to treat at a cost of approximately £19,200 per patient and associated with a significant loss of income in our MTC. Cost codes should reflect the complex and more expensive treatment of these patients to avoid the inadvertent financial 'penalties' of treating such patients. This study is the first to calculate the direct inpatient treatment costs of open lower limb fractures in a major trauma centre. It highlights the need for cost saving strategies and for appropriate remuneration in MTCs.

The cost of infection in severe open tibial fractures treated with a free flap.

PURPOSE: Open tibial fractures needing soft tissue cover are challenging injuries. Infection risk is high, making treatment difficult and expensive. Delayed skin closure has been shown to increase the infection rate in several studies. We aimed at calculating the direct and indirect cost of treatment, and to determine the effect of delayed skin closure on this cost. METHODS: We reviewed all records of patients treated with a free flap in our institution for an open tibial fracture from 2002 to 2013. We calculated direct costs based on length of stay (LOS) and orthopaedic and plastic surgical procedures performed, including medications and intensive care. We analysed indirect cost in terms of absenteeism and unemployment benefits. The primary goal was to establish the extra cost incurred by an infection. RESULTS: We analysed 46 injuries in 45 patients. Infection increased the LOS from 41 to 74 days and increased the cost of treatment from € 49,817 in uninfected fractures to € 81,155 for infected fractures. Employed patients spent 430 days more on unemployment benefits, than a matched cohort in the background population. Achieving skin cover within seven days of injury decreased the infection rate from 60 to 27 %. CONCLUSIONS: Severe open tibial fractures covered with free flaps, cause over a year of absenteeism. Infection increases direct cost of treatment over 60 % and roughly doubles LOS. Early soft-tissue cover and correct antibiotics have been shown to improve outcomes-underscoring the need for rapid referral to centres with an ortho-plastic set-up to handle such injuries.

Pre-packing of cost effective antibiotic cement beads for the treatment of traumatic osteomyelitis in the developing world - an in-vitro study based in Cambodia.

The developing world often lacks the resources to effectively treat the most serious injuries including osteomyelitis following open fractures or surgical fracture treatment. Antibiotic cement beads are a widely accepted method of delivering antibiotics locally to the infected area following trauma. This study is based in Cambodia, a low income country struggling to recover from a recent genocide. The study aims to test the effectiveness of locally made antibiotic beads and analyse their effectiveness after being gas sterilised, packaged and kept in storage Different antibiotic beads were manufactured locally using bone cement and tested against MRSA bacteria grown from a case of osteomyelitis. Each antibiotic was tested before and after a process of gas sterilisation as well as later being tested after storage in packaging up to 42 days. The gentamicin, vancomycin, amikacin and ceftriaxone beads all inhibited growth of the MRSA on the TSB and agar plates, both before and after gas sterilisation. All four antibiotics continued to show similar zones of inhibition after 42 days of storage. The results show significant promise to produce beads with locally obtainable ingredients in an austere environment and improve cost effectiveness by storing them in a sterilised condition.

The service impact of failed locking plate fixation of distal tibial fractures: a service and financial evaluation at a major trauma centre.

INTRODUCTION: The surgical treatment of distal tibial fractures is challenging and controversial. Recently, locking plate fixation has become popular, but the outcomes of this treatment are mixed with complication rates as high as 50 % in the published literature. There are no reports specifically relating to the financial and resource costs of failed treatment in the literature. METHOD: Retrospective service analysis of patients who had undergone locking plate fixation of a distal third tibial fracture between 2008 and 2011 with at least 12 months follow-up. Rates of readmission, reoperation, bony union and infection were ascertained. The financial and resource (hospital stay and number of outpatient appointments) implications of failed treatment were calculated. RESULTS: Forty-two patients were identified. There were 31 type A fractures, one type B fracture and 10 type C fractures. Three injuries were open. Twenty patients were treated with minimally invasive percutaneous osteosynthesis (MIPO). The readmission and reoperation rates were 26 % (n = 11) and 19 % (n = 8), respectively. A total of 89 % of readmissions were due to infection. All patients had received appropriate antibiotic regimens. The average costs of successful and failed treatment were £ 5538 and £ 18,335, respectively. The average time to union was 24.5 weeks. The rate of non-union was 21 % (n = 9). The rate of infection was 28 % (n = 12), with all patients with open fracture incurring an infection. Tourniquet time had no effect on the incidence of complications. Smokers were more likely to incur a complication (p < 0.05), and non-union was lower in the MIPO group (p < 0.05). The length and total cost of inpatient care were significantly lower in the MIPO group (p < 0.05). MIPO patients were five times less likely to incur readmission or reoperation. Failed treatment was three times more expensive and four times longer than successful treatment. CONCLUSION: The study identified a large burden to the service following failure of locking plate treatment of these fractures, but the outcomes were similar to series published in the literature. Readmission rates were high following these injuries, and failed treatment was costly and had a significant impact on hospital resources. The implementation of major trauma networks and centralised subspecialised units should improve quality and value for money.

Effects of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III open tibia fractures treated with unreamed nails-A clinical and health-economic analysis.

Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) is licensed in Europe for open tibia fractures treated with unreamed nails. However, there is limited data available on the specific use of rhBMP-2 in combination with unreamed nails for open tibia fractures. The intention of the current study was to evaluate the medical and health-economic effects of rhBMP-2 in Gustilo-Anderson grade III open tibia fractures treated with unreamed nails based on individual patient data from two previously published studies. Linear regression analysis was performed on raw data of 90 patients that were either treated by standard of care with soft tissue management and unreamed nailing (SOC group) (n=50) or with rhBMP-2 in addition to soft tissue management and unreamed nailing (rhBMP-2 group) (n=40). For all types of revision, a significant lower percentage of patients (27.5%) of the rhBMP-2 group had to be revised compared to 48% of the patients of the SOC group (p=0.04). When only invasive secondary interventions such as bone grafting and nail exchange were considered, there was also a statistically significant reduction in the rhBMP-2 group with a revision rate of 10.0% (4 of 40 patients) compared to the SOC group with a revision rate of 28.0% (14 of 50 patients) (p=0.01). Mean fracture healing time of 228 days in the rhBMP-2 compared to 266 days in the SOC group was not statistically significant (p=0.24). Health-economic analysis based on a societal perspective with calculation of overall treatment costs after initial surgery and including productivity losses revealed savings of €6,239 per patient for Germany and €4,752 for the UK in favour of rhBMP-2 which was mainly driven by reduction of productivity losses. In conclusion, rhBMP-2 reduces secondary interventions in patients with grade III open tibia fractures treated with an unreamed nail and its use leads to financial savings for Germany and the UK from a societal perspective.

Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Lower Limb Fractures (UK WOLLF).

INTRODUCTION: Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures. METHODS AND ANALYSIS: All adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12 months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patients' experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12 months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12 months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1 year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05. ETHICS AND DISSEMINATION: Ethical approval was given by NRES Committee West Midlands-Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences. TRIAL REGISTRATION NUMBER: ISRCTN33756652.

The use of secure anonymised data linkage to determine changes in healthcare utilisation following severe open tibial fractures.

Severe open fractures of the lower limbs are complex injuries requiring expert multidisciplinary management in appropriate orthoplastic centres. This study aimed to assess the impact of open fractures on healthcare utilisation and test the null hypotheses that there is no difference in healthcare utilisation between the year before and year after injury, and that there is no difference in healthcare utilisation in the year post-injury between patients admitted directly to an orthoplastic centre in keeping with the joint BOA/BAPRAS standards and those having initial surgery elsewhere. This retrospective cohort study utilising secure anonymised information linkage (SAIL), a novel databank of anonymised nationally pooled health records, recruited patients over 18 years of age sustaining severe open lower limb fractures managed primarily or secondarily at our centre and who had data available in the SAIL databank. 101 patients met inclusion criteria and 90 of these had records in the SAIL databank. The number of days in hospital, number of primary care attendances, number of outpatient attendances and number of emergency department attendances in the years prior and subsequent to injury were recorded. Patients sustaining open fractures had significantly different healthcare utilisation in the year after injury when compared with the year before, in terms of days spent in hospital (23.42 vs. 1.70, p=0.000), outpatient attendances (11.98 vs. 1.05, p=0.000), primary care attendances (29.48 vs. 11.99, p=0.000) and emergency department presentations (0.2 vs. 0.01, p=0.025). Patients admitted directly to orthoplastic centres had significantly fewer operations (1.78 vs. 3.31) and GP attendances (23.6 vs. 33.52) than those transferred in subsequent to initial management in other units. There is a significant increase in healthcare utilisation after open tibial fracture. Adherence to national standards minimises the impact of this on both patients and health services.

Decision analysis for fracture management in cattle.

Bovine fractures are common and each bovine patient is unique, presents innumerable challenges, and requires careful judgment. In cattle the fracture repair usually should be of acceptable quality to not cause a decrease in milk or meat production or interfere with natural breeding. The decision to treat a fracture in cattle is made by evaluating the cost and success rates of the treatment, the value of the animal, and the location and type of fracture.

The cost of after-hours operative debridement of open tibia fractures.

OBJECTIVES: The aim of this study was to evaluate the additional cost associated with performing after-hours operative debridement of open fractures within 6 hours of injury. DATA SOURCES: The economic model is based on population estimates obtained from the National Trauma Database and the National Inpatient Sample on the number of open tibia fractures that occur annually in the United States and the number that present after-hours (between 6 PM and 2 AM) that undergo operative debridement within 6 hours. This model estimates incremental cost for after-hours surgery based on overtime wages for on-call personnel (nurses and surgical technicians) required to staff after-hours cases as published by the US Department of Labor and data from our own institution. As many level 1 hospitals are capable of performing after-hours cases without additional cost, a sensitivity analysis was performed to determine the effect of designated level of care of the trauma hospital. DATA EXTRACTION AND SYNTHESIS: A total of 17,414 open tibia fractures were recorded in the National Inpatient Sample for 2009, and an estimated 7485 open tibia fractures presented after-hours, 4242 of which underwent operative debridement within 6 hours of presentation. Based on wage statistics from the US Department of Labor and our own institution, the estimated total additional cost for after-hours operative debridement of open tibia fractures within 6 hours is from $2,210,895 to $4,046,648 annually, respectively. For level 2 hospitals and below, the cost of performing after-hours operative debridement of open tibia fractures is calculated as from $1,532,980 to $2,805,846 annually. CONCLUSIONS: The data indicated an increased overall financial cost of performing after-hours operative debridement of open tibia fractures. Given that there is minimal documented benefit to this practice, and with increased pressure to practice cost containment, elective delay of operative debridement of open fractures and/or transfer to a higher level of care trauma hospital may be an acceptable way to address these issues. LEVEL OF EVIDENCE: Economic analysis level III. See instructions for authors for a complete description of levels of evidence.

The influence of procedure delay on resource use: a national study of patients with open tibial fracture.

BACKGROUND: The purpose of this study was to (1) understand national variation in delay of emergency procedures in patients with open tibial fracture at the hospital level and (2) compare length of stay and cost in patients cared for at the best- and worst-performing hospitals for delay. METHODS: The authors retrospectively analyzed the 2003 to 2009 Nationwide Inpatient Sample. Adult patients with open tibial fracture were included. Hospital probability of delay in performing emergency procedures beyond the day of admission was calculated. Multilevel linear regression random-effects models were created to evaluate the relationship between the treating hospital's tendency for delay (in quartiles) and the log-transformed outcomes of length of stay and cost. RESULTS: The final sample included 7029 patients from 332 hospitals. Patients treated at hospitals in the fourth (worst) quartile for delay were estimated to have 12 percent (95 percent CI, 2 to 21 percent) higher cost compared with patients treated at hospitals in the first quartile. In addition, patients treated at hospitals in the fourth quartile had an estimated 11 percent (95 percent CI, 4 to 17 percent) longer length of stay compared with patients treated at hospitals in the first quartile. CONCLUSIONS: Patients with open tibial fracture treated at hospitals with more timely initiation of surgical care had lower cost and shorter length of stay than patients treated at hospitals with less timely initiation of care. Policies directed toward mitigating variation in care may reduce unnecessary waste.