Aims. Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. Methods. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment. Results. This paper describes the full details of the planned methods of analysis and descriptive statistics. The DRAFFT2 study protocol has been published previously. Conclusion. The planned analysis strategy described records our intent to conduct statistical and within-trial cost-utility analyses. Cite this article: Bone Joint Open 2020;1-6:245–252

Aim

This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial.

Economic evaluation provides a framework for assessing the costs and consequences of alternative programmes or interventions. One common vehicle for economic evaluations in the healthcare context is the decision-analytic model, which synthesizes information on parameter inputs (for example, probabilities or costs of clinical events or health states) from multiple sources and requires application of mathematical techniques, usually within a software program. A plethora of decision-analytic modelling-based economic evaluations of orthopaedic interventions have been published in recent years. This annotation outlines a number of issues that can help readers, reviewers, and decision-makers interpret evidence from decision-analytic modelling-based economic evaluations of orthopaedic interventions. Cite this article: Bone Joint J 2023;105-B(1):17–20

Aims. 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). Methods. 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. Results. There were 111,402 patients operatively managed for orthopaedic trauma, with 2,775 of these (2.5%) complicated by FRI. The development of FRI had a statistically significant association with older age, male sex, residing in rural/remote areas, Aboriginal or Torres Strait Islander background, lower socioeconomic status, road traffic accident, work-related injuries, open fractures, anatomical region (lower limb, spine, pelvis), high injury severity, requiring soft-tissue coverage, and medical comorbidities (univariate analysis). Patients with FRI had an eight-times longer median inpatient length of stay (24 days vs 3 days), and a 2.8-times higher mean estimated inpatient hospitalization cost (AU$56,565 vs AU$19,773) compared with uninfected patients. The total estimated inpatient cost of the FRI cohort to the healthcare system was AU$156.9 million over the ten-year period. Conclusion. The results of this study advocate for improvements in trauma care and infection management, address social determinants of health, and highlight the upside potential to improve prevention and treatment strategies. Cite this article: Bone Joint J 2024;106-B(1):77–85

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

Aims. This study aims to estimate economic outcomes associated with 30-day deep surgical site infection (SSI) from closed surgical wounds in patients with lower limb fractures following major trauma. Methods. Data from the Wound Healing in Surgery for Trauma (WHiST) trial, which collected outcomes from 1,547 adult participants using self-completed questionnaires over a six-month period following major trauma, was used as the basis of this empirical investigation. Associations between deep SSI and NHS and personal social services (PSS) costs (£, 2017 to 2018 prices), and between deep SSI and quality-adjusted life years (QALYs), were estimated using descriptive and multivariable analyses. Sensitivity analyses assessed the impact of uncertainty surrounding components of the economic analyses. Results. Compared to participants without deep SSI, those with deep SSI had higher mean adjusted total NHS and PSS costs (adjusted mean difference £1,577 (95% confidence interval (CI) -951 to 4,105); p = 0.222), and lower mean adjusted QALYs (adjusted mean difference -0.015 (95% CI -0.032 to 0.002); p = 0.092) over six months post-injury, but this difference was not statistically significant. The results were robust to the sensitivity analyses performed. Conclusion. This study found worse economic outcomes during the first six months post-injury in participants who experience deep SSI following orthopaedic surgery for major trauma to the lower limb. However, the increase in cost associated with deep SSI was less than previously reported in the orthopaedic trauma literature. Cite this article: Bone Jt Open 2022;3(5):398–403

Health economic evaluations potentially provide valuable information to clinicians, health care administrators, and policy makers regarding the financial implications of decisions about the care of patients. The highest quality research should be used to inform decisions that have direct impact on the access to care and the outcome of treatment. However, economic analyses are often complex and use research methods which are relatively unfamiliar to clinicians. Furthermore, health economic data have substantial national, regional, and institutional variability, which can limit the external validity of the results of a study. Therefore, minimum guidelines that aim to standardise the quality and transparency of reporting health economic research have been developed, and instruments are available to assist in the assessment of its quality and the interpretation of results. The purpose of this editorial is to discuss the principal types of health economic studies, to review the most common instruments for judging the quality of these studies and to describe current reporting guidelines. Recommendations for the submission of these types of studies to The Bone & Joint Journal are provided. Cite this article: Bone Joint J 2016;98-B:147–51

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

Aims. The aim of this study was to estimate the clinical and economic burden of dislocation following primary total hip arthroplasty (THA) in England. Methods. This retrospective evaluation used data from the UK Clinical Practice Research Datalink database. Patients were eligible if they underwent a primary THA (index date) and had medical records available 90 days pre-index and 180 days post-index. Bilateral THAs were excluded. Healthcare costs and resource use were evaluated over two years. Changes (pre- vs post-THA) in generic quality of life (QoL) and joint-specific disability were evaluated. Propensity score matching controlled for baseline differences between patients with and without THA dislocation. Results. Among 13,044 patients (mean age 69.2 years (SD 11.4), 60.9% female), 191 (1.5%) had THA dislocation. Two-year median direct medical costs were £15,333 (interquartile range (IQR) 14,437 to 16,156) higher for patients with THA dislocation. Patients underwent revision surgery after a mean of 1.5 dislocations (1 to 5). Two-year costs increased to £54,088 (IQR 34,126 to 59,117) for patients with multiple closed reductions and a revision procedure. On average, patients with dislocation had greater healthcare resource use and less improvement in EuroQol five-dimension index (mean 0.24 (SD 0.35) vs 0.44 (SD 0.35); p < 0.001) and visual analogue scale (0.95 vs 8.85; p = 0.038) scores, and Oxford Hip Scores (12.93 vs 21.19; p < 0.001). Conclusion. The cost, resource use, and QoL burden of THA dislocation in England are substantial. Further research is required to understand optimal timing of revision after dislocation, with regard to cost-effectiveness and impact on QoL. Cite this article: Bone Joint J 2022;104-B(7):811–819

Aims. The practice of alternating operating theatres has long been used to reduce surgeon idle time between cases. However, concerns have been raised as to the safety of this practice. We assessed the payments and outcomes of total knee arthroplasty (TKA) performed during overlapping and nonoverlapping days, also comparing the total number of the surgeon’s cases and the total time spent in the operating theatre per day. Materials and Methods. A retrospective analysis was performed on the Centers for Medicare & Medicaid Services (CMS) Limited Data Set (LDS) on all primary elective TKAs performed at the New England Baptist Hospital between January 2013 and June 2016. Using theatre records, episodes were categorized into days where a surgeon performed overlapping and nonoverlapping lists. Clinical outcomes, economic outcomes, and demographic factors were calculated. A regression model controlling for the patient-specific factors was used to compare groups. Total orthopaedic cases and aggregate time spent operating (time between skin incision and closure) were also compared. Results. A total of 3633 TKAs were performed (1782 on nonoverlapping days; 1851 on overlapping days). There were no differences between the two groups for length of inpatient stay, payments, mortality, emergency room visits, or readmission during the 90-day postoperative period. The overlapping group had 0.74 fewer skilled nursing days (95% confidence interval (CI) -0.26 to -1.22; p < 0.01), and 0.66 more home health visits (95% CI 0.14 to 1.18; p = 0.01) than the nonoverlapping group. On overlapping days, surgeons performed more cases per day (5.01 vs 3.76; p < 0.001) and spent more time operating (484.55 minutes vs 357.17 minutes; p < 0.001) than on nonoverlapping days. Conclusion. The study shows that the practice of alternating operating theatres for TKA has no adverse effect on the clinical outcome or economic utilization variables measured. Furthermore, there is opportunity to increase productivity with alternating theatres as surgeons with overlapping cases perform more cases and spend more time operating per day. Cite this article: Bone Joint J 2019;101-B:1081–1086

Aims. 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. Methods. 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. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213

Cost is a factor in the choice of prosthetic components in joint replacement. For a given performance, the least expensive components are the most cost-effective. When evaluating a new prosthesis with an unknown outcome, the use of an economic model allows estimation of potential cost-effectiveness. We used published data for the survival of cemented total hip replacements from Sweden, and cost and demographic information from New South Wales, Australia, in such a model. In young active total hip recipients a new prosthetic design which offered a 90% improvement in survivorship over 15 years and a 15% reduction in the cost of revision surgery, could be sold at a price of 2 to 2.5 times that of conventional cemented components such as the Charnley Low Friction Arthroplasty and still be cost-effective. Using more likely estimates of the improved performance of new technology, however, the upper limit of cost-effectiveness is an increase of 1.5 to 1. Only a very small increase in the cost of a prosthesis could ever be justified for older patients of either sex. Most of the potential benefits of a better level of survivorship appear towards the end of the 15-year period. The results of modelling may be incorporated in clinical trial design. Given the known performance of some well-established and relatively inexpensive designs of prostheses, very large randomised studies would be required to prove an improvement in performance

Aims. The aim of this study was to evaluate the healthcare costs and benefits of enoxaparin compared to aspirin in the prevention of symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA) or total knee arthroplasty (TKA) using data from the CRISTAL trial. Methods. This trial-based economic analysis reports value for money as incremental cost per quality-adjusted life-year (QALY) gained in 2022 Australian dollars, compared to a single threshold value of AUD$70,000 per QALY. Event costs were estimated based on occurrence of VTEs and bleeds, and on published guidelines for treatment. Unit costs were taken from Australian sources. QALYs were estimated using CRISTAL six-month follow-up data. Sensitivity analyses are presented that vary the cost of VTE treatment, and extend the analyses to two years. Results. The CRISTAL trial found that enoxaparin was more effective than aspirin in preventing symptomatic VTE within 90 days of THA or TKA (risk difference 1.97% (95% confidence interval (CI) 0.54% to 3.41%; p = 0.007)). The additional cost after a THA or TKA was AUD$83 (95% CI 68 to 97) for enoxaparin, and enoxaparin resulted in an additional 0.002 QALYs (95% CI -0.002 to 0.005). Incremental cost per QALY gained was AUD$50,567 (95% CI 15,513, dominated) for enoxaparin. We can be 60% confident that the incremental cost per QALY does not exceed the willingness-to-pay threshold of AUD$70,000. Increasing the cost of VTE treatment and extension of costs and consequences to two years suggested greater confidence that enoxaparin is good value for money (70% and 63% confidence, respectively). Conclusion. This analysis provides strong evidence that enoxaparin thromboprophylaxis following THA or TKA reduced VTEs, but weak evidence of net economic benefits over aspirin. If the value of avoiding VTEs is high, and there is a strong likelihood of VTE-related health impairments, we can be more confident that enoxaparin is cost-effective compared to aspirin. Cite this article: Bone Joint J 2024;106-B(6):589–595

Aims. To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. Methods. A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically. Results. The incremental cost and QALYs of using brace over a 12-month period were £46.73 (95% confidence interval (CI) £-9 to £147) and 0.0141 (95% CI -0.005 to 0.033), respectively. The cost per QALY gained was £3,318. The probability of brace being cost-effective at a £30,000 per QALY willingness-to-pay threshold was 88%. The results remained robust to a range of sensitivity analyses. Conclusion. This within-trial economic evaluation found that it is probable that using a removable brace provides good value to the NHS when compared to cast, in the management of adults with ankle fracture. Cite this article: Bone Jt Open 2022;3(6):455–462

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

Aims. To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Methods. Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The base-case analysis showed that high-dose, dual-antibiotic cement had a significantly higher mean cost (£224 (95% confidence interval (CI) -408 to 855)) and almost the same QALYs (0.001 (95% CI -0.002 to 0.003)) relative to single-antibiotic cement from the UK NHS and PSS perspective. The probability of the high-dose, dual-antibiotic cement being cost-effective was less than 0.3 at alternative cost-effectiveness thresholds, and its net monetary benefit was negative. This finding remained robust in the sensitivity analyses. Conclusion. This study shows that high-dose, dual-antibiotic cement is unlikely to be cost-effective compared to single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Cite this article: Bone Joint J 2023;105-B(10):1070–1077

Aims. The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment. Results. The offer of a soft bandage significantly reduced cost per patient (saving £12.55 (95% confidence interval (CI) -£5.30 to £19.80)) while QALYs were similar (QALY difference between groups: 0.0013 (95% CI -0.0004 to 0.003)). The high probability (95%) that offering a bandage is a cost-effective option was consistent when examining the data in a range of sensitivity analyses. Conclusion. In addition to the known clinical equivalence, this study found that the offer of a bandage reduced cost compared with rigid immobilization among children with a torus fracture of the distal radius. While the cost saving was small for each patient, the high frequency of these injuries indicates a significant saving across the healthcare system. Cite this article: Bone Joint J 2024;106-B(6):623–630

Aims. The aim of this study was to compare the cost-effectiveness of surgical fixation with Kirschner (K-)wire ersus moulded casting after manipulation of a fracture of the distal radius in an operating theatre setting. Methods. An economic evaluation was conducted based on data collected from the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) multicentre randomized controlled trial in the UK. Resource use was collected at three, six, and 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from an NHS and personal social services perspective. Sensitivity analyses were conducted to examine the robustness of cost-effectiveness estimates, and decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. In the base case analysis, surgical fixation with K-wire was more expensive (£29.65 (95% confidence interval (CI) -94.85 to 154.15)) and generated lower QALYs (0.007 (95% CI -0.03 to 0.016)) than moulded casting, but this difference was not statistically significant. The probability of K-wire being cost-effective at a £20,000 per QALY cost-effectiveness threshold was 24%. The cost-effectiveness results remained robust in the sensitivity analyses. Conclusion. The findings suggest that surgical fixation with K-wire is unlikely to be a cost-effective alternative to a moulded cast in adults, following manipulation of a fracture of the distal radius in a theatre setting. Cite this article: Bone Joint J 2022;104-B(11):1225–1233

Aims. Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. Methods. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments. Discussion. There is currently no high-quality evidence comparing the clinical and cost effectiveness of the tension suture repair to the traditional tension band wiring currently offered for the internal fixation of displaced fractures of the olecranon. The Simple Olecranon Fracture Fixation Trial (SOFFT) is a randomized controlled trial with sufficient power and design rigour to provide this evidence for the subtype of Mayo grade IIA fractures. Cite this article: Bone Jt Open 2023;4(1):27–37

Aims. To estimate the potential cost-effectiveness of adalimumab compared with standard care alone for the treatment of early-stage Dupuytren’s disease (DD) and the value of further research from an NHS perspective. Methods. We used data from the Repurposing anti-TNF for Dupuytren’s disease (RIDD) randomized controlled trial of intranodular adalimumab injections in patients with early-stage progressive DD. RIDD found that intranodular adalimumab injections reduced nodule hardness and size in patients with early-stage DD, indicating the potential to control disease progression. A within-trial cost-utility analysis compared four adalimumab injections with no further treatment against standard care alone, taking a 12-month time horizon and using prospective data on EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and resource use from the RIDD trial. We also developed a patient-level simulation model similar to a Markov model to extrapolate trial outcomes over a lifetime using data from the RIDD trial and a literature review. This also evaluated repeated courses of adalimumab each time the nodule reactivated (every three years) in patients who initially responded. Results. The within-trial economic evaluation found that adalimumab plus standard care cost £503,410 per quality-adjusted life year (QALY) gained versus standard care alone over a 12-month time horizon. The model-based extrapolation suggested that, over a lifetime, repeated courses of adalimumab could cost £14,593 (95% confidence interval £7,534 to £42,698) per QALY gained versus standard care alone. If the NHS was willing to pay £20,000/QALY gained, there is a 77% probability that adalimumab with retreatment is the best value for money. Conclusion. Repeated courses of adalimumab are likely to be a cost-effective treatment for progressive early-stage DD. The value of perfect parameter information that would eliminate all uncertainty around the parameters estimated in RIDD and the duration of quiescence was estimated to be £105 per patient or £272 million for all 2,584,411 prevalent cases in the UK. Cite this article: Bone Jt Open 2022;3(11):898–906

Aims. Within healthcare, several measures are used to quantify and compare the severity of health conditions. Two common measures are disability weight (DW), a context-independent value representing severity of a health state, and utility weight (UW), a context-dependent measure of health-related quality of life. Neither of these measures have previously been determined for developmental dysplasia of the hip (DDH). The aim of this study is to determine the DW and country-specific UWs for DDH. Methods. A survey was created using three different methods to estimate the DW: a preference ranking exercise, time trade-off exercise, and visual analogue scale (VAS). Participants were fully licensed orthopaedic surgeons who were contacted through national and international orthopaedic organizations. A global DW was calculated using a random effects model through an inverse-variance approach. A UW was calculated for each country as one minus the country-specific DW composed of the time trade-off exercise and VAS. Results. Over a four-month period, 181 surgeons participated in the survey, with 116 surgeons included in the final analysis. The global DW calculated to be 0.18 (0.11 to 0.24), and the country-specific UWs ranged from 0.26 to 0.89. Conclusion. This is the first time that a global disability weight and country-specific utility weights have been estimated for DDH, which should assist in economic evaluations and the development of health policy. The methodology may be applied to other orthopaedic conditions. Cite this article: Bone Jt Open 2023;4(3):120–128

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 economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment. Anticipated impact. The 12-month results will be presented and published internationally. This is anticipated to be the only pragmatic trial reporting outcomes comparing surgical with non-surgical treatment in unstable ankle fractures in younger adults (aged 60 years and younger), and, as such, will inform the National Institute for Health and Care Excellence (NICE) ‘non-complex fracture’ recommendations at their scheduled update in 2024. A report of long-term outcomes at five years will be produced by January 2027. Cite this article: Bone Jt Open 2024;5(3):184–201

Aims. The aim of this study was to compare the cost-effectiveness of cemented hemiarthroplasty (HA) versus hydroxyapatite-coated uncemented HA for the treatment of displaced intracapsular hip fractures in older adults. Methods. A within-trial economic evaluation was conducted based on data collected from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized controlled trial in the UK. Resource use was measured over 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from the NHS and personal social service perspective. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was represented graphically using confidence ellipses and cost-effectiveness acceptability curves. Results. The base-case analysis showed that cemented implants were cost-saving (mean cost difference -£961 (95% confidence interval (CI) -£2,292 to £370)) and increased QALYs (mean QALY difference 0.010 (95% CI 0.002 to 0.017)) when compared to uncemented implants. The probability of the cemented implant being cost-effective approximated between 95% and 97% at alternative cost-effectiveness thresholds held by decision-makers, and its net monetary benefit was positive. The findings remained robust against all the pre-planned sensitivity analyses. Conclusion. This study shows that cemented HA is cost-effective compared with hydroxyapatite-coated uncemented HA in older adults with displaced intracapsular hip fractures. Cite this article: Bone Joint J 2022;104-B(8):922–928

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication. Cite this article: Bone Jt Open 2024;5(5):411–418

Aims. The aim of this systematic review and meta-analysis was to gather epidemiological information on selected musculoskeletal injuries and to provide pooled injury-specific incidence rates. Methods. PubMed (National Library of Medicine) and Scopus (Elsevier) databases were searched. Articles were eligible for inclusion if they reported incidence rate (or count with population at risk), contained data on adult population, and were written in English language. The number of cases and population at risk were collected, and the pooled incidence rates (per 100,000 person-years) with 95% confidence intervals (CIs) were calculated by using either a fixed or random effects model. Results. The screening of titles yielded 206 articles eligible for inclusion in the study. Of these, 173 (84%) articles provided sufficient information to be included in the pooled incidence rates. Incidences of fractures were investigated in 154 studies, and the most common fractures in the whole adult population based on the pooled incidence rates were distal radius fractures (212.0, 95% CI 178.1 to 252.4 per 100,000 person-years), finger fractures (117.1, 95% CI 105.3 to 130.2 per 100,000 person-years), and hip fractures (112.9, 95% CI 82.2 to 154.9 per 100,000 person-years). The most common sprains and dislocations were ankle sprains (429.4, 95% CI 243.0 to 759.0 per 100,000 person-years) and first-time patellar dislocations (32.8, 95% CI 21.6 to 49.7 per 100,000 person-years). The most common injuries were anterior cruciate ligament (17.5, 95% CI 6.0 to 50.2 per 100,000 person-years) and Achilles (13.7, 95% CI 9.6 to 19.5 per 100,000 person-years) ruptures. Conclusion. The presented pooled incidence estimates serve as important references in assessing the global economic and social burden of musculoskeletal injuries. Cite this article: Bone Joint Res 2022;11(11):814–825

Implant-related infection is one of the leading reasons for failure in orthopaedics and trauma, and results in high social and economic costs. Various antibacterial coating technologies have proven to be safe and effective both in preclinical and clinical studies, with post-surgical implant-related infections reduced by 90% in some cases, depending on the type of coating and experimental setup used. Economic assessment may enable the cost-to-benefit profile of any given antibacterial coating to be defined, based on the expected infection rate with and without the coating, the cost of the infection management, and the cost of the coating. After reviewing the latest evidence on the available antibacterial coatings, we quantified the impact caused by delaying their large-scale application. Considering only joint arthroplasties, our calculations indicated that for an antibacterial coating, with a final user’s cost price of €600 and able to reduce post-surgical infection by 80%, each year of delay to its large-scale application would cause an estimated 35 200 new cases of post-surgical infection in Europe, equating to additional hospital costs of approximately €440 million per year. An adequate reimbursement policy for antibacterial coatings may benefit patients, healthcare systems, and related research, as could faster and more affordable regulatory pathways for the technologies still in the pipeline. This could significantly reduce the social and economic burden of implant-related infections in orthopaedics and trauma. Cite this article: C. L. Romanò, H. Tsuchiya, I. Morelli, A. G. Battaglia, L. Drago. Antibacterial coating of implants: are we missing something? Bone Joint Res 2019;8:199–206. DOI: 10.1302/2046-3758.85.BJR-2018-0316

Aims. Degenerative cervical spondylosis (DCS) is a common musculoskeletal disease that encompasses a wide range of progressive degenerative changes and affects all components of the cervical spine. DCS imposes very large social and economic burdens. However, its genetic basis remains elusive. Methods. Predicted whole-blood and skeletal muscle gene expression and genome-wide association study (GWAS) data from a DCS database were integrated, and functional summary-based imputation (FUSION) software was used on the integrated data. A transcriptome-wide association study (TWAS) was conducted using FUSION software to assess the association between predicted gene expression and DCS risk. The TWAS-identified genes were verified via comparison with differentially expressed genes (DEGs) in DCS RNA expression profiles in the Gene Expression Omnibus (GEO) (Accession Number: GSE153761). The Functional Mapping and Annotation (FUMA) tool for genome-wide association studies and Meta tools were used for gene functional enrichment and annotation analysis. Results. The TWAS detected 420 DCS genes with p < 0.05 in skeletal muscle, such as ribosomal protein S15A (RPS15A) (PTWAS = 0.001), and 110 genes in whole blood, such as selectin L (SELL) (PTWAS = 0.001). Comparison with the DCS RNA expression profile identified 12 common genes, including Apelin Receptor (APLNR) (PTWAS = 0.001, PDEG = 0.025). In total, 148 DCS-enriched Gene Ontology (GO) terms were identified, such as mast cell degranulation (GO:0043303); 15 DCS-enriched Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways were identified, such as the sphingolipid signalling pathway (ko04071). Nine terms, such as degradation of the extracellular matrix (R-HSA-1474228), were common to the TWAS enrichment results and the RNA expression profile. Conclusion. Our results identify putative susceptibility genes; these findings provide new ideas for exploration of the genetic mechanism of DCS development and new targets for preclinical intervention and clinical treatment. Cite this article: Bone Joint Res 2023;12(1):80–90

Aims. The primary aim was to estimate the cost-effectiveness of routine operative fixation for all patients with humeral shaft fractures. The secondary aim was to estimate the health economic implications of using a Radiographic Union Score for HUmeral fractures (RUSHU) of < 8 to facilitate selective fixation for patients at risk of nonunion. Methods. From 2008 to 2017, 215 patients (mean age 57 yrs (17 to 18), 61% female (n = 130/215)) with a nonoperatively managed humeral diaphyseal fracture were retrospectively identified. Union was achieved in 77% (n = 165/215) after initial nonoperative management, with 23% (n = 50/215) uniting after surgery for nonunion. The EuroQol five-dimension three-level health index (EQ-5D-3L) was obtained via postal survey. Multiple regression was used to determine the independent influence of patient, injury, and management factors upon the EQ-5D-3L. An incremental cost-effectiveness ratio (ICER) of < £20,000 per quality-adjusted life-year (QALY) gained was considered cost-effective. Results. At a mean of 5.4 yrs (1.2 to 11.0), the mean EQ-5D-3L was 0.736 (95% confidence interval (CI) 0.697 to 0.775). Adjusted analysis demonstrated the EQ-5D-3L was inferior among patients who united after nonunion surgery (β = 0.103; p = 0.032). Offering routine fixation to all patients to reduce the rate of nonunion would be associated with increased treatment costs of £1,542/patient, but would confer a potential EQ-5D-3L benefit of 0.120/patient over the study period. The ICER of routine fixation was £12,850/QALY gained. Selective fixation based on a RUSHU < 8 at six weeks post-injury would be associated with reduced treatment costs (£415/patient), and would confer a potential EQ-5D-3L benefit of 0.335 per ‘at-risk patient’. Conclusion. Routine fixation for patients with humeral shaft fractures to reduce the rate of nonunion observed after nonoperative management appears to be a cost-effective intervention at five years post-injury. Selective fixation for patients at risk of nonunion based on their RUSHU may confer even greater cost-effectiveness, given the potential savings and improvement in health-related quality of life. Cite this article: Bone Jt Open 2022;3(7):566–572

Aims. To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. Methods. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results. The incremental cost of standard dressing versus iNPWT over six months was £2,037 (95% confidence interval (CI) £349 to £3,724). There was an insignificant increment in QALYs gained in the iNPWT group (0.005, 95% CI -0.018 to 0.028). The probability of iNPWT being cost-effective at £20,000 per QALY was 1.9%. The results remained robust in the sensitivity analysis. Conclusion. The within-trial economic evaluation suggests that iNPWT is unlikely to be a cost-effective alternative to standard dressing in adults with closed surgical wounds to their lower limbs. Cite this article: Bone Joint J 2020;102-B(8):1072–1081

Aims. To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty. Methods. A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature; analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision; prospective data analyses from 560 patients to understand how patients present for revision surgery; qualitative interviews with NHS managers and orthopaedic surgeons; and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas. Results. The UK poSt Arthroplasty Follow-up rEcommendations (UK SAFE) recommendations apply to post-primary hip and knee arthroplasty follow-up. The ten-year time point is based on a lack of robust evidence beyond ten years. The term 'complex cases' refers to individual patient and surgical factors that may increase the risk for arthroplasty failure. For Orthopaedic Data Evaluation Panel (ODEP) 10A* minimum implants, it is safe to disinvest in routine follow-up from one to ten years post-non-complex hip and knee arthroplasty provided there is rapid access to orthopaedic review. For ODEP 10A* minimum implants in complex cases, or non-ODEP 10A* minimum implants, periodic follow-up post-hip and knee arthroplasty may be required from one to ten years. At ten years post-hip and knee arthroplasty, clinical and radiological evaluation is recommended. After ten years post-hip and knee arthroplasty, frequency of further follow-up should be based on the ten-year assessment; ongoing rapid access to orthopaedic review is still required. Conclusion. Complex cases, implants not meeting the ODEP 10A* criteria, and follow-up after revision surgery are not covered by this recommendation. Cite this article: Bone Jt Open 2023;4(2):72–78

Aims. Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579

Aim. The aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and ‘locking’ plate fixation in the treatment of extra-articular fractures of the distal tibia. Patients and Methods. An economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates. Results. Mean NHS and PSS costs were significantly lower for patients treated with an intramedullary nail than for those treated with a locking plate (-£970, 95% confidence interval (CI) -1685 to -256; p = 0.05). There was a small increase in QALYs gained in the nail fixation group (0.01, 95% CI -0.03 to 0.06; p = 0.52). The probability of cost-effectiveness for nail fixation exceeded 90% at cost-effectiveness thresholds as low as £15 000 per additional QALY. The cost-effectiveness results remained robust to several sensitivity analyses. Conclusion. This trial-based economic evaluation suggests that nail fixation is a cost-effective alternative to locking plate fixation. Cite this article: Bone Joint J 2018;100-B:624–33

Aims. Total hip arthroplasty (THA) is one of the most successful surgical procedures. The objectives of this study were to define whether there is a correlation between socioeconomic status (SES) and surgical complications after elective primary unilateral THA, and investigate whether access to elective THA differs within SES groups. Methods. We conducted a retrospective, population-based cohort study involving 202 hospitals in Ontario, Canada, over a 17-year period. Patients were divided into income quintiles based on postal codes as a proxy for personal economic status. Multivariable logistic regression models were then used to primarily assess the relationship between SES and surgical complications within one year of index THA. Results. Of 111,359 patients who underwent elective primary THA, those in the lower SES groups had statistically significantly more comorbidities and statistically significantly more postoperative complications. While there was no increase in readmission rates within 90 days, there was a statistically significant difference in the primary and secondary outcomes including all revisions due (with a subset of deep wound infection and dislocation). Results showed that those in the higher SES groups had proportionally more cases performed than those in lower groups. Compared to the highest SES quintile, the lower groups had 61% of the number of hip arthroplasties performed. Conclusion. Patients in lower socioeconomic groups have more comorbidities, fewer absolute number of cases performed, have their procedures performed in lower-volume centres, and ultimately have higher rates of complications. This lack of access and higher rates of complications is a “double hit” to those in lower SES groups, and indicates that we should be concentrating efforts to improve access to surgeons and hospitals where arthroplasty is routinely performed in high numbers. Even in a universal healthcare system where there are no penalties for complications such as readmission, there seems to be an inequality in the access to THA. Cite this article: Bone Joint J 2022;104-B(5):589–597

Aims. The rate of dislocation when traditional single bearing implants are used in revision total hip arthroplasty (THA) has been reported to be between 8% and 10%. The use of dual mobility bearings can reduce this risk to between 0.5% and 2%. Dual mobility bearings are more expensive, and it is not clear if the additional clinical benefits constitute value for money for the payers. We aimed to estimate the cost-effectiveness of dual mobility compared with single bearings for patients undergoing revision THA. Methods. We developed a Markov model to estimate the expected cost and benefits of dual mobility compared with single bearing implants in patients undergoing revision THA. The rates of revision and further revision were calculated from the National Joint Registry of England and Wales, while rates of transition from one health state to another were estimated from the literature, and the data were stratified by sex and age. Implant and healthcare costs were estimated from local procurement prices and national tariffs. Quality-adjusted life-years (QALYs) were calculated using published utility estimates for patients undergoing THA. Results. At a minimum five-year follow-up, the use of dual mobility was cost-effective with an estimated incremental cost-effectiveness ratio (ICER) of between £3,006 and £18,745/QALY for patients aged < 55 years and between 64 and 75 years, respectively. For those aged > 75 years dual mobility was only cost-effective if the timeline was beyond seven years. The use of dual mobility bearings was cost-saving for patients aged < 75 years and cost-effective for those aged > 75 years if the time horizon was beyond ten years. Conclusion. The use of dual mobility bearings is cost-effective compared with single bearings in patients undergoing revision THA. The younger the patient is, the more likely it is that a dual mobility bearing can be more cost-effective and even cost-saving. The results are affected by the time horizon and cost of bearings for those aged > 75 years. For patients aged > 75 years, the surgeon must decide whether the use of a dual mobility bearing is a viable economic and clinical option. Cite this article: Bone Joint J 2020;102-B(9):1128–1135

Aims. The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose pragmatic suggestions for its introduction into medical assessment. Methods. We reviewed the literature concerning the present status of online medical and surgical assessment to establish the perceived benefits, limitations, and potential problems with this method of assessment. Results. Global experience with online, remote virtual examination has been largely successful with many benefits conferred to the trainee, and both an economic and logistical advantage conferred to the assessor or organization. Advances in online examination software and remote proctoring are overcoming practical caveats including candidate authentication, cheating prevention, cybersecurity, and IT failure. Conclusion. Virtual assessment provides benefits to both trainee and assessor in medical and surgical examinations and may also result in cost savings. Virtual assessment is likely to be increasingly used in the post-COVID world and we present recommendations for the continued adoption of virtual examination. It is, however, currently unable to completely replace clinical assessment of trainees. Cite this article: Bone Jt Open 2021;2(2):111–118

Aims. The aim of this study was to assess the quality and scope of the current cost-effectiveness analysis (CEA) literature in the field of hand and upper limb orthopaedic surgery. Materials and Methods. We conducted a systematic review of MEDLINE and the CEA Registry to identify CEAs that were conducted on or after 1 January 1997, that studied a procedure pertaining to the field of hand and upper extremity surgery, that were clinical studies, and that reported outcomes in terms of quality-adjusted life-years. We identified a total of 33 studies that met our inclusion criteria. The quality of these studies was assessed using the Quality of Health Economic Analysis (QHES) scale. Results. The mean total QHES score was 82 (high-quality). Over time, a greater proportion of these studies have demonstrated poorer QHES quality (scores < 75). Lower-scoring studies demonstrated several deficits, including failures in identifying reference perspectives, incorporating comparators and sensitivity analyses, discounting costs and utilities, and disclosing funding. Conclusion. It will be important to monitor the ongoing quality of CEA studies in orthopaedics and ensure standards of reporting and comparability in accordance with Second Panel recommendations. Cite this article: Bone Joint J 2018;100-B:1416–23

Aims. This aim of this study was to assess the feasibility of designing and introducing generic 3D-printed instrumentation for routine use in total knee arthroplasty. Materials and Methods. Instruments were designed to take advantage of 3D-printing technology, particularly ensuring that all parts were pre-assembled, to theoretically reduce the time and skill required during surgery. Concerning functionality, ranges of resection angle and distance were restricted within a safe zone, while accommodating either mechanical or anatomical alignment goals. To identify the most suitable biocompatible materials, typical instrument shapes and mating parts, such as dovetails and screws, were designed and produced. Results. Before and after steam sterilization, dimensional analysis showed that acrylonitrile butadiene styrene could not withstand the temperatures without dimensional changes. Oscillating saw tests with slotted cutting blocks produced debris, fractures, or further dimensional changes in the shape of Nylon-12 and polymethylmethacrylate (MED610), but polyetherimide ULTEM 1010 was least affected. Conclusion. The study showed that 3D-printed instrumentation was technically feasible and had some advantages. However, other factors, such as whether all procedural steps can be accomplished with a set of 3D-printed instruments, the logistics of delivery, and the economic aspects, require further study. Cite this article: Bone Joint J 2019;101-B(7 Supple C):115–120

Aims. The routine use of dual-mobility (DM) acetabular components in total hip arthroplasty (THA) may not be cost-effective, but an increasing number of patients undergoing THA have a coexisting spinal disorder, which increases the risk of postoperative instability, and these patients may benefit from DM articulations. This study seeks to examine the cost-effectiveness of DM components as an alternative to standard articulations in these patients. Patients and Methods. A decision analysis model was used to evaluate the cost-effectiveness of using DM components in patients who would be at high risk for dislocation within one year of THA. Direct and indirect costs of dislocation, incremental costs of using DM components, quality-adjusted life-year (QALY) values, and the probabilities of dislocation were derived from published data. The incremental cost-effectiveness ratio (ICER) was established with a willingness-to-pay threshold of $100 000/QALY. Sensitivity analysis was used to examine the impact of variation. Results. In the base case, patients with a spinal deformity were modelled to have an 8% probability of dislocation following primary THA based on published clinical ranges. Sensitivity analysis revealed that, at its current average price ($1000), DM is cost-effective if it reduces the probability of dislocation to 0.9%. The threshold cost at which DM ceased being cost-effective was $1180, while the ICER associated with a DM THA was $71 000 per QALY. Conclusion. These results indicate that under specific clinical and economic thresholds, DM components are a cost-effective form of treatment for patients with spinal deformity who are at high risk of dislocation after THA. Cite this article: Bone Joint J 2018;100-B:1297–1302

Aims. This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. Patients and Methods. Data for patients’ use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. Results. With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. Conclusion. At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526–32

It is becoming widely accepted that research which considers only the outcome and not the costs associated with new technologies in health care, is of limited value in making decisions about the use of scarce resources. Economic evaluation is becoming a standard feature of clinical research but many published economic evaluations fall short of best practice in their methodology. We have described the essential features of economic evaluation, using published studies in orthopaedics, in order to try to improve the ability of orthopaedic surgeons to read, understand and appraise such studies critically, and to encourage them to consider including economic evaluation in future investigations

Aims. Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. Patients and Methods. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients. Results. All measures showed significant changes between the preoperative score and the various postoperative times (p < 0.001). Most improvement occurred during the first three months, with small but significant changes between three and six months, and no further change between six and 12 months postoperatively. SRM scores for EQ-5D, PROMIS-10, and OKS were large (> 0.8). ROC curves showed that both EQ-5D and PROMIS-10 were able to discriminate between patients who achieved the OKS MCID and those who did not (area under the curve (AUC) of 0.7 to 0.82). Conclusion. The PROMIS-10 physical health tool showed greater responsiveness to change than the EQ-5D, most probably due to the additional questions on physical health parameters that are more susceptible to modification following TKA. The EQ-5D was, however, shown to be sensitive to clinically meaningful change following TKA, and provides the additional ability to calculate health economic utility scores. It is likely, therefore, that EQ-5D will continue to be the global health metric of choice in the United Kingdom. Cite this article: Bone Joint J 2019;101-B:832–837

Aims. The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. Patients and Methods. Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. Results. OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. Conclusion. These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383–92

Aims

To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS).

Aims

The aim of this study was to describe the current pathways of care for patients with a fracture of the hip in five low- and middle-income countries (LMIC) in South Asia (Nepal and Sri Lanka) and Southeast Asia (Malaysia, Thailand, and the Philippines).

Aims. We reviewed all patients who sustained a fracture of the hip and were treated in Northern Ireland over a period of 15 years to identify trends in incidence, the demographics of the patients, the rates of mortality, the configuration of the fracture and the choice of implant. Patients and Methods. Since 01 January 2001 data about every fracture of the hip sustained in an adult have been collected centrally in Northern Ireland. All adults with such a fracture between 2000 and 2015 were included in the study. Temporal changes in their demographics, the mode of treatment, and outcomes including mortality were analysed. Results. The incidence of fractures of the hip, in Northern Ireland, rose from 54 in 100 000 in 2000 to 86 in 100 000 in 2015. If these trends continue, we predict this rising to 128 in 100 000 in 2030. We found that these patients are becoming older and increasingly frail, as assessed by the American Association of Anesthesiology grade. Complex extracapsular fractures have become more common since 2009, which may explain the increased use of cephalomedullary nails. Despite increasing frailty, the 30-day and 12-month rates of mortality fell significantly (p = 0.002 and 0.001, respectively). Conclusion. Fractures of the hip are becoming more common and more complex in an aging, increasingly frail population. We expect these trends to continue. This will place an increasing economic and clinical strain on healthcare systems. Forward planning is essential to put systems in place that can deal with the increasing demand. Cite this article: Bone Joint J 2017;99-B:1223–31

Aims

The aim of this study was to report the pooled prevalence of post-traumatic osteoarthritis (PTOA) and examine whether the risk of developing PTOA after anterior cruciate ligament (ACL) injury has decreased in recent decades.