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. 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.Aims
Methods
Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.Aims
Methods
The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial. Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.Aims
Methods
Component mal-positioning in total hip replacement (THR) and total knee replacement (TKR) can increase the risk of revision for various reasons. Compared to conventional surgery, relatively improved accuracy of implant positioning can be achieved using computer assisted technologies including navigation, patient-specific jigs, and robotic systems. However, it is not known whether application of these technologies has improved prosthesis survival in the real-world. This study aimed to compare risk of revision for all-causes following primary THR and TKR, and revision for dislocation following primary THR performed using computer assisted technologies compared to conventional technique. We performed an observational study using National Joint Registry data. All adult patients undergoing primary THR and TKR for osteoarthritis between 01/04/2003 to 31/12/2020 were eligible. Patients who received metal-on-metal bearing THR were excluded. We generated propensity score weights, using Sturmer weight trimming, based on: age, gender, ASA grade, side, operation funding, year of surgery, approach, and fixation. Specific additional variables included position and bearing for THR and patellar resurfacing for TKR. For THR, effective sample sizes and duration of follow up for conventional versus computer-guided and robotic-assisted analyses were 9,379 and 10,600 procedures, and approximately 18 and 4 years, respectively. For TKR, effective sample sizes and durations of follow up for conventional versus computer-guided, patient-specific jigs, and robotic-assisted groups were 92,579 procedures over 18 years, 11,665 procedures over 8 years, and 644 procedures over 3 years, respectively. Outcomes were assessed using Kaplan-Meier analysis and expressed using hazard ratios (HR) and 95% confidence intervals (CI).Abstract
Introduction
Methods
The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.Aims
Methods
To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. 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.Aims
Methods
Prosthetic joint infections (PJI) are a devastating consequence in total hip arthroplasties (THA) with both significant morbidity and sometimes mortality, posing a significant health economic burden. Studies, both clinical and in-vitro have suggested possible reduction in PJI with the use of ceramic bearings. We have investigated the relationship of ceramic-on-ceramic (CoC), ceramic-on-polyethylene (CoP) or metal-on-polyethylene (MoP) bearing surface in affecting outcome of revision surgery after primary THA using data collected from National Joint Registry for England and Wales, Northern Ireland and the Isle of Man between 2002 and 2016. We used a competing risk regression model to investigate predictors of each revision outcome, such as infection, dislocation, aseptic revision and all cause revisions. The results were adjusted for age, gender, ASA grade, BMI, indication for surgery, intraoperative complications and implant data. We identified 456,457 THA (228,786 MoP, 128,403 CoC and 99,268 CoP). In a multivariable model, the adjusted risk of revision for PJI was lower with CoC (OR-0.748, p<0.001) and CoP (OR-0.775, p<0.001) when compared to MoP bearing. Additionally there was also a significant reduction in the risk of all cause revision for CoC (OR-0.918, p=0.002) and CoP (0.806, p<0.001), bearings as compared with MoP. The protective effect of ceramic bearing was predominantly seen after two years of implantation with a significant (p<0.0001) reduction of revision for PJI in both CoC (by 42.8%) and CoP (by 41.3%) group. Similarly significant effect was seen for aseptic revision beyond two years and overall all cause revision rate beyond two years reduced by 21.6% for CoC and 27.1% for CoP (p<0.001). Within the limits of registry analysis, this study has demonstrated an association between the use of ceramic bearing and lower rates of revision for all cause revisions especially infection and aseptic loosening. This finding supports the use of ceramic bearings in THA.
Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.Aims
Methods
Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre.Aims
Methods
National Institute for Health and Clinical Excellence (NICE) guidelines recommend the use of total hip replacement (THR) for displaced intracapsular fractured neck of femur (NOF) in cognitively intact patients who were independently mobile prior to the injury. The National Joint Registry for England and Wales (NJR) has collected data on THRs performed since 2003. This retrospective cohort study explores risk factors independently associated with implant failure and perioperative mortality. NJR data recording a THR performed for acute fractured NOF between 2003 and 2010 were analysed. Cox proportional hazards models were used to analyse the extent to which risk of implant revision was related to specific covariates. Multivariable logistic regression was used to analyse factors affecting 90-day perioperative mortality. Significance was taken as p< 0.01.Introduction
Methods
Following in-depth analysis of the market leading brand combinations in which we identified implant influences on risk of revision, we compared revision in patients implanted with different categories of hip replacement in order to find implant with the lowest revision risk, once known flawed options were removed. All patients with osteoarthritis who underwent a hip replacement (2003–2010) using an Exeter-Contemporary (cemented), Corail-Pinnacle (cementless), Exeter-Trident (Hybrid) or a Birmingham Hip resurfacing (BHR) were initially included within the analysis. Operations involving factors that were significant predictors of revision were excluded. Cox proportional hazard models were then used to assess the relative risk of revision for a category of implant (compared with cemented), after adjustment for patient covariates.Introduction
Methods
Total knee replacements (TKR) are among the commonest operations performed in orthopaedic practice. Literature review showed that 10-30% of patients who underwent TKR needed 1-3 units of blood. Tranexamic acid (TXA) has been popularised as an effective way to reduce blood loss and subsequent blood transfusion. Our aim was to investigate the value of TXA in reducing blood loss and blood transfusion after TKR and other clinical outcomes such as deep venous thrombosis (DVT), pulmonary embolism (PE), ischaemic heart diseases and mortality. A systematic review and meta-analysis of published randomised and quasi-randomised trials which used TXA to reduce blood loss in knee arthroplasty were conducted.Introduction
Patients and Methods
To investigate the value of tranexamic acid (TA) in reducing blood loss and blood transfusion after TKR and other clinical outcomes such as deep venous thrombosis (DVT), pulmonary embolism (PE), ischaemic heart diseases and mortality. A systematic review and meta-analysis of published randomised and quasi-randomised trials which used TA to reduce blood loss in knee arthroplasty was conducted. The data was evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group.Objectives
Methods
Although safer than ever, allogeneic transfusion is still associated with risks for the recipient (haemolysis, infection, immunosuppression, transfusion-related acute lung injury and even death). Tranexamic acid (TA) is a synthetic antifibrinolytic agent that has been successfully used to stop bleeding after dental operation, removal of tonsils, prostate surgery, heavy menstrual bleeding, eye injuries and in patients with Haemophilia. In this study Tranexamic acid was applied topically to the exposed tissue around the knee joint prior to the wound closure and tourniquet release. It is anticipated that this method of administration is quick, easy, associated with less systemic side effect. Also, it provides a higher concentration of the Tranexamic acid at the bleeding site.
Since the era of total knee replacement (TKR) began in the late 1960s, total knee replacement has become one of the commonest operations in orthopaedic practice. TKR is frequently associated with transfusion of allogenic blood Benoni G 1995; Seppo T 1997. In our centre, 30 % of patients who had undergone TKR received allogenc blood transfusion perioperatively. Although, serological screening has reduced the risk for viral infection to a very low levelKlein HG 1995; Schreiber GB 1996, the public is still concerned about this potential serious complication. Allogenic blood transfusion can be also associated with other non infectious complications such as haemolysis, immunosuppression, transfusion-related acute lung injury and even death.Madjdpour C 2005 Therefore, further refinement of strategies to avoid exposure to allogeneic blood is needed. Amongst the technologies to minimise the need for blood transfusion is the use of the anti-fibrinolytic drugs aprotinin, tranexamic acid (TXA), and epsilon amino-caproic acid (EACA).New Reference
