Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.

Aims: Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. Methods: This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation. Conclusion: This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024.

Cost-utility analysis of cemented hemiarthroplasty versus hydroxyapatite-coated uncemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures : the World Hip Trauma Evaluation 5 (WHiTE 5) trial.

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.

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.

Cost-utility analysis of standard dressing compared with incisional negative-pressure wound therapy among patients with closed surgical wounds following major trauma to the lower limb.

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.

Randomised controlled trial comparing hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: a protocol for the WHITE 5 study.

INTRODUCTION: Hip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture. METHODS AND ANALYSIS: Multicentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted. ETHICS, DISSEMINATION AND FUNDING: Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres. TRIAL REGISTRATION NUMBER: ISRCTN18393176.