Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation

Summary Statement. Using current analysis/methodology, new implant technology is unlikely to demonstrate a large enough change in patient function to impact on the cost-effectiveness of the procedure. Purpose. Cost effectiveness is an increasingly important metric in today's healthcare environment, and decisions surrounding which arthroplasty prosthesis to implant are not exempt from such health economic concerns. Quality adjusted life years (QALYs) are the typical assessment tool for this type of evaluation. Using this methodology, joint arthroplasty has been shown to be cost effective, however studies directly comparing the QALY achieved by differing prostheses are lacking. Methods. Data was gathered in a single centre prospective double-blind randomised controlled trial comparing the outcome a modern implant, the Triathlon total knee replacement, with its traditionally designed predecessor the Kinemax, using the Short Form 6 dimensional (SF-6D) score and quality adjusted life year (QALY) methodology. The study cohort consisted of 64 patients that were randomised to a Triathlon and 60 randomised to a Kinemax. Results. There was a significant improvement in the SF-6D score for both groups at one year compared with pre-operative scores (p<0.0001). The calculated overall life expectancy for the study cohort was 15.1 years, which resulted in an overall QALY gain of 2.144 (95% CI 1.752–2.507). The modern implant group demonstrated only a small improvement in the SF-6D score compared to the traditional design at one year (0.141 versus 0.143, p=0.94). This difference in health gain resulted in the modern implant costing £298 less per QALY at one year, however this saving diminished to less than £30 per year over the lifetime of the cohort. Discussion. This study demonstrates that despite comparing 2nd and 4th generation design, modern implant technology does not influence the cost-effectiveness of TKA using the SF-6D and QALY methodology. As most implants demonstrate similar longevity, differences in patient function will likely carry the greatest influence on QALY. This type of analysis however assesses health status, and is not sensitive to joint specific function. Dramatic differences in patient outcome would be required to influence QALY score. Evolutionary design changes in implant technology are thus unlikely to influence QALY analysis following joint replacement, which has important implication for implant procurement

Background. The Arthroplasty Pain Experience (APEX) studies are two randomised controlled trials in primary total hip (THR) and knee replacement (TKR) at a large UK orthopaedics centre. APEX investigated the effect of local anaesthetic wound infiltration (LAI), administered before wound closure, in addition to standard analgesia, on pain severity at 12 months. This abstract reports results of the within-trial economic evaluations. Methods. Cost-effectiveness was assessed from the health and social care payer perspective in relation to quality adjusted life years (QALYs). Resource use was collected from hospital records and patient-completed postal questionnaires, and valued using unit cost estimates from local NHS Trust and national tariffs. Missing data were imputed using chained equations. Costs and outcomes were compared per trial arm and plotted in cost-effectiveness planes. The economic results were bootstrapped incremental net monetary benefit statistics (INMB) and cost-effectiveness acceptability curves. One-way deterministic sensitivity analyses explored any methodological uncertainty. Results. In both trials, LAI was cost-saving and more effective than standard care. Using the £20,000 per QALY threshold, in THR, the INMB was £1,125 (95%BCI, £183 to £2,067) and the probability of being cost-effective was over 98%. In TKR, the INMB was £264 (95%BCI, −£710 to £1,238), with only 62% probability of being cost-effective. Considering an NHS perspective only, LAI was no longer dominant in THR, but still highly cost-effective, with an INMB of £961 (95%BCI, £50 to £1,873). Conclusions. Administering LAI is a cost-effective treatment option in THR and TKR surgeries. The evidence is stronger for THR, because of larger QALY gain. In TKR, there is more uncertainty around the economic result, and smaller QALY gains, but results point to LAI being cheaper than standard analgesia, which includes a femoral nerve block. Trial Registration. ISRCTN96095682, 29/04/2010. Funding. NIHR Programme Grant for Applied Research RP-PG-0407-10070

Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total hip replacement (THR). We assessed the effectiveness of LAI using a systematic review and a fully powered randomised controlled trial (RCT) with economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving THR. Two reviewers screened abstracts, extracted data, and liaised with authors. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. If feasible, we conducted meta-analysis. In the APEX RCT, we randomised 322 patients awaiting THR to receive additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline) or standard anaesthesia alone. Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, we identified 13 studies (909 patients). Patients undergoing THR receiving LAI experienced greater pain reduction at 24 hours at rest, standardised mean difference (SMD) −0.61 (95%CI −1.05, −0.16; p=0.008) and at 48 hours during activity, SMD −0.43 (95%CI −0.78, −0.09; p=0.014). Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Long-term outcomes were not a focus of these studies. In the APEX RCT, pain levels in hospital were broadly similar between groups, probably due to patient-controlled analgesia. Opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. Patients receiving LAI were less likely to report severe pain at 12 months than those receiving standard care, odds ratio 10.2 (95%CI 2.1, 49.6; p=0.004). Complications were similar between groups. In the economic evaluation, LAI was associated with lower costs and greater cost-effectiveness than standard care. Using a £20,000 per QALY threshold, the incremental net monetary benefit was £1,125 (95%CI £183, £2,067) and the probability of being cost-effective was greater than 98 %. The evidence suggests that peri-operative LAI is a cost-effective intervention for reducing acute and chronic post-surgical pain after THR

Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total knee replacement (TKR). To assess the effectiveness of peri-operative LAI for pain management in patients receiving TKR we conducted a systematic review, fully powered randomised controlled trial (RCT) and economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving TKR. Two reviewers screened abstracts and extracted data. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. Authors were contacted if required. When feasible, we conducted meta-analysis with studies analysed separately if a femoral nerve block (FNB) was provided. In the APEX RCT, we randomised 316 patients awaiting TKR to standard anaesthesia which included FNB, or to the same regimen with additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline). Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, 23 studies including 1,439 patients were identified. Compared with patients receiving no intervention, LAI reduced WOMAC-Pain by standardised mean difference (SMD) −0.40 (95%CI −0.58, −0.22; p<0.001) at 24 hours at rest and by SMD −0.27 (95%CI −0.50, −0.05; p=0.018) at 48 hours during activity. In three studies there was no difference in pain at any time point between randomised groups where all patients received FNB. Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Few studies reported long-term outcomes. In the APEX RCT, pain levels in hospital were broadly similar between groups. Overall opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. There were no differences in pain outcomes between groups at 12 months. In the economic evaluation, LAI was marginally associated with lower costs. Using the NICE £20,000 per QALY threshold, the incremental net monetary benefit was £264 (95%CI, −£710, £1,238) and the probability of being cost-effective was 62%. Although LAI appeared to have some benefit for reduced pain in hospital after TKR there was no evidence of pain control additional to that provided by femoral nerve block, however it would be cost-effective at the current NICE thresholds