Aims

Hip fractures pose a significant burden on the healthcare system. Hyperglycaemia and a state of Type 2 diabetes exists post operatively. Being normoglycaemic has well documented benefits. Pre operative carbohydrate loading has been shown to have two good effects. It decrease hyperglycaemia post operatively and allows the patient to undergo less strict fasting protocols. Insulin resistance to date has not been examined in these patients and this was determined using a validated formula (HOMA/IR).

Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103

Aim. Prosthetic joint infection (PJI) is a much feared complication to arthroplasty with significant patient morbidity. Rifampin is increasingly used in staphylococcal PJIs treated with debridement and retention of the prosthesis. The evidence supporting rifampin combination therapy in PJIs is limited due to the lack of controlled studies. The aim of this study is to evaluate the effect of adding rifampin to conventional antimicrobial therapy in early staphylococcal PJIs treated with debridement and retention. Method. In this multicentre randomized controlled trial, 99 patients with PJI after hip and knee arthroplasties were enrolled. All patients underwent a standardized surgical debridement. 65 patients had PJI caused by staphylococci and further included in the study. They were randomly assigned to receive rifampin or not in addition to standard antimicrobial therapy with cloxacillin, or vancomycin in case of methicillin resistance. They received parenteral antibiotics for two weeks, then oral antibiotics for 4 weeks. In case of methicillin resistance, vancomycin was administered i.v. for 6 weeks. The primary end point was no signs of infection after 2 wears follow-up. Results. 48 patients were included in the final analyses. There were no differences in patient characteristics or co-morbidities between the two groups. There was no significant difference in remission rate between the rifampin combination group (17 of 23 (74%)) and the monotherapy group (18 of 25 (72%), relative risk 1,03; 95% confidence interval 0,73 to 1,45, p=0.88). Five patients aborted the rifampin treatment because of adverse effects and continued with monotherapy. All five had complete remission. These patients were not included in the final analysis. Conclusions. Our study has not proven a statistically significant advantage by adding rifampicin to the antibiotic treatment in staphylococcal PJIs. Bigger studies on the subject are needed. Our good success rate raises the question whether the standardized revision surgery is the key to success in these infections rather than rifampin

Purpose. A recent multicentre randomized control trial (RCT) failed to demonstrate superior quality of life at one year following open reduction and internal fixation (ORIF) compared to nonoperative treatment for unstable isolated fibular fractures. We sought to determine the cost-effectiveness of ORIF compared to non-operative management of unstable fibular fractures. Method. A decision tree was used to model the results of a multicentre trial comparing ORIF versus nonoperative treatment for isolated fibular fractures. A single payer, governmental perspective was used for the analysis. Utilities (a measure of preference for a health state) were obtained from the subjects Short-Form-6D scores and used to calculated Quality Adjusted Life Years (QALYs). Probabilities for each strategy were taken from the one-year trial endpoint. Costs were obtained from the Ontario Case Costing Initiative. Sensitivity analysis was performed for all model variables to determine when ORIF is a cost-effective treatment (incremental cost per QALY gained < $75,000). Results. Nonoperative management was the preferred treatment during the one-year time-horizon. The nonoperative treatment strategy had an average cost of $2,099 $885 for an average gain of 0.717 0.064 QALYs. ORIF had an average cost of $6,455 $3,589 for an average gain of 0.734 0.051 QALYs. The incremental cost effectiveness ratio for the ORIF treatment was $256,235 per QALY. ORIF becomes the preferred treatment at extreme values for its costs (< $1,450) and its effectiveness (QALY > 0.81). Conclusion. From a single-payer, governmental perspective open reduction and internal fixation does not appear to be cost-effective; however, if operative fixation decreases the lifetime incidence of post-traumatic ankle arthrosis or a broader societal perspective with a higher willingness to pay threshold is adopted, then the economic attractiveness of ORIF would improve