Purpose. There is increasing evidence that primary fixation of displaced mid-shaft fractures of the clavicle results in superior short-term outcomes when compared to traditional non-operative methods. However, the results from published studies are limited to relatively short-term (one year or less) follow-up. Accurate data of longer follow-up is important for a number of reasons, including patient prognostication, counseling and care, the design of future trials, and the economic analysis of treatment. The purpose of this paper was to examine the results of the two year follow up of patients enrolled in a previously published randomized clinical trial of operative versus non-operative treatment of displaced fractures of the clavicle. Method. Using a comprehensive and standard assessment that included DASH (Disabilities of the Arm, Shoulder and Hand) and CSS (Constant Shoulder Scores) scores, we evaluated ninety-five patients of the original cohort of one hundred and thirty-two patients at two years following their injury. Results. Statistical analysis performed on the two year follow up data revealed that DASH and CSS scores remained essentially unchanged at two years post-injury compared to one year post-injury for both operative and non-operative groups (p>0.05). Additionally, outcome scores in the operative group remained superior to the non-operative group (DASH operative 4 +/− 7 versus DASH non-operative 11 +/− 20, p<0.014, CSS operative 97 +/− 4 versus CSS non-operative 92 +/− 14, p<0.012) at two years post-injury. Conclusion. The improvement in outcome seen with primary fixation of displaced clavicle fractures persists at two years but does not differ significantly from values seen after one year of follow-up, suggesting that clinically a steady state has been reached whereby outcome is unlikely to change with time. This has clinical, economic, and research implications

The ability to calculate quality-adjusted life-years (QALYs) for degenerative cervical myelopathy (DCM) would enhance treatment decision making and facilitate economic analysis. QALYs are calculated using utilities, or health-related quality-of-life (HRQoL) weights. An instrument designed for cervical myelopathy disease would increase the sensitivity and specificity of HRQoL assessments. The objective of this study is to develop a multi-attribute utility function for the modified Japanese Orthopedic Association (mJOA) Score. We recruited a sample of 760 adults from a market research panel. Using an online discrete choice experiment (DCE), participants rated 8 choice sets based on mJOA health states. A multi-attribute utility function was estimated using a mixed multinomial-logit regression model (MIXL). The sample was partitioned into a training set used for model fitting and validation set used for model evaluation. The regression model demonstrated good predictive performance on the validation set with an AUC of 0.81 (95% CI: 0.80-0.82)). The regression model was used to develop a utility scoring rubric for the mJOA. Regression results revealed that participants did not regard all mJOA domains as equally important. The rank order of importance was (in decreasing order): lower extremity motor function, upper extremity motor function, sphincter function, upper extremity sensation. This study provides a simple technique for converting the mJOA score to utilities and quantify the importance of mJOA domains. The ability to evaluate QALYs for DCM will facilitate economic analysis and patient counseling. Clinicians should use these findings in order to offer treatments that maximize function in the attributes viewed most important by patients

Robotic and navigated TKA procedures have been introduced to improve component placement precision for the purpose of improving implant survivorship and other clinical outcomes. Although numerous studies have shown enhanced precision in placing components, adoption of technology-assistance (TA) for TKA has been relatively slow. One reason for this has been the difficulty in demonstrating the cost-effectiveness of implementing TA-TKA systems and assessing their impact on revision rates. In this study, we aimed to use a simulation approach to answer the following questions: (1) Can we determine the distribution of likely reductions in TKA revision rates attributable to TA-TKA in an average US patient population? And, (2) What reduction in TKA revision rates are required to achieve economic neutrality?. In a previous study, we developed a method for creating large sets of simulated TKA patient populations with distributions of patient-specific factors (age at index surgery, sex, BMI) and one surgeon-controlled factor (coronal alignment) drawn from registry data and published literature. Effect sizes of each factor on implant survival was modeled using large clinical studies. For 10,000 simulated TKA patients, we simulated 20,000 TKA surgeries, evenly split between groups representing coronal alignment precisions reported for manual (±3°) and TA-TKA (±1.0°), calculating the patient-specific survival curve for each group. Extending our previous study, we incorporated the probability of each patient's expected survival into our model using publicly available actuarial data. This allowed us to calculate a patient-specific estimate of the Reduction in Lifetime Risk of Revision (RLRR) for each simulated patient. Our analysis showed that 90% of patients will achieve an RLRRof 1.5% or less in an average US TKA population. We then conducted a simplified economic analysis with the goal of determining the net cost of using TA-TKA per case when factoring in future savings by TKA revision rates. We assumed an average cost of revision surgery to be $75,000 as reported by Delanois (2017) and an average added cost incurred by TA-TKA to be $6,000 per case as reported by Antonis (2019). We estimate the net cost per TA-TKA case (CNet) to be the added cost per TA-TKA intervention (CInt), less the cost of revision surgery (CRev) multiplied by the estimated RLRR: CNet = CInt - CRev∗RLRR. We find that, under these assumptions, use of TA-TKA increases expected costs for all patients with an RLRR of under 8%. Based on these results, it appears that it would not be cost-effective to use TA-TKA on more than a small fraction of the typical US TKA patient population if the goal is to reduce overall costs through reducing revision risks. However, we note that this simulation does not consider other possible reported benefits of TA-TKA surgery, such as improved functional and pain outcome scores which may justify its use on other grounds. Alternative costs incurred by TA-TKA will be evaluated in a future study. To reach economic neutrality, TA-TKA systems either must reduce the added cost per intervention or increase RLRR by better addressing the root causes of revision

Introduction. Total knee arthroplasty is a highly effective procedure to improve the quality of life in patients with advanced osteoarthritis. The number of these procedures are expected to grow 174% by 2030. This growth rate is expected to economically strain the health care system. A potential solution to alleviate this problem is the utilization of single use instruments (SUI). Potential advantages of SUI include: improved operating room efficiencies, decreased costs associated with traditional instrument management (sterile processing, shipping), and decreased infection risk. The present study examines the clinical results of SUI compared to standard instrumentation. Furthermore, economic modeling is performed to examine the cost savings that is potentially realized with their use. Materials and Methods. 51 patients receiving a TKA with use of SUI were prospectively compared to 49 patients utilizing standard instrumentation. Knee Society Scores and Radiographic alignment will be evaluated. Adverse events will be recorded. Economic modeling of SUI will be performed in 4 different areas: 1. Decreased infection burden; 2. Operating room logistics; 3. Sterile processing savings; and 4. Instrument logistical savings. Results. The average Pre-operative KSS (Objective/Functional) scores were 48.7/41.6 for the SIU patients compared to 50.2/38.7 for the standard instrumentation patients. Post-operative improvements measured 84.0/72.8 and 83.9/76.4 for the 2 groups respectively. The Pre-operative Hip-Knee-Ankle Angle was 176.2 and 177.0 for the 2 groups. The SUI HKA improved to 179.3 while the standard improved to 178.9. There were no statistical differences between the 2 groups. Furthermore, there were no cases of subsidence, migration, loosening, or infection in either group. There were no SUI procedure abandonments. Economic analysis revealed a decreased risk of Infection burden of $28.08/case. Operating room efficiencies include reduced set-up/take-down time and case efficiency savings/case. This averages $348.14/case. Instrument sterilization savings occur by bypassing the central sterile-processing department completely and models to $700/case. Finally, instrument logistics savings include time and money spent organizing/turning over/shipping instrument sets for cases. This estimate is $112.88/case for a total economic value of $1, 189.10/case. Discussion. In summary, the present study confirms that SUI provides similar clinical and radiographic results to standard instrumentation for TKA. Furthermore, SUI offers significant cost savings/case via potential benefits of reduced risk of infection, increased operating room productivity, and significant tray sterilization and loaner instrumentation cost savings

There is ongoing debate regarding the optimal surgical treatment of complex proximal humeral fractures in elderly patients. The aim of this study was to evaluate the cost-effectiveness of reverse total shoulder arthroplasty (RTSA) compared to hemiarthroplasty (HA) in the management of these fractures. A cost–utility analysis using decision tree and Markov modelling based on data from the published literature was conducted. A single-payer perspective with a lifetime time horizon was adopted. A willingness to pay threshold of CAD $50,000 was used. The incremental cost-effectiveness ratio (ICER) was used as the study's primary outcome measure. In comparison to HA, the incremental cost per QALY gained for RTSA was $13,679. One-way sensitivity analysis revealed the model to be sensitive to the RTSA implant cost and the RTSA procedural costs. Two-way sensitivity analysis suggested RTSA could also be cost-effective within the first two years of surgery with an early complication rate as high as 25% (if RTSA implant cost was approximately $3,000); or conversely, RTSA implant cost could be as high as $8,500 if its early complication rates were 5%. The ICER of $13,679 is well below the WTP threshold of $50,000 and probabilistic sensitivity analysis demonstrated that 92.6% of model simulations favoured RTSA. Our economic analysis found that RTSA for the treatment of complex proximal humeral fractures in the elderly is the preferred economic strategy when compared to HA. The ICER of RTSA is well-below standard willingness to pay thresholds, and its estimate of cost-effectiveness is similar to other highly successful orthopaedic strategies such as total hip arthroplasty for the treatment of hip arthritis

Aim. Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting. Method. This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%. Results. Of 1054 participants randomised (527 to each arm) endpoint data were available for 1015 (96.30%). Definitive treatment failure was identified in 141/1015 (13.89%) participants, 74/506 (14.62%) of those randomised to IV therapy and 67/509 (13.16%) of those randomised to oral therapy. In the intention to treat analysis, the imputed risk difference (PO-IV) for definitive treatment failure was −1.38% (90% CI: −4.94, 2.19), thus meeting the non-inferiority criterion (i.e. the upper limit of 95%CI being <7.5%). A complete cases analysis, a per-protocol analysis and sensitivity analyses for missing data confirmed this result. With the exception of intravenous catheter complications, there was no significant difference between the two arms in the incidence of serious adverse events (SAEs). Health economic analysis suggests that the non-surgical treatment costs over one year for patients randomised to oral therapy were approximately £2,700 less than those of IV therapy. Conclusions. Oral antibiotic therapy is non-inferior to IV therapy when used during the first six weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within one year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy. Funding. The OVIVA study was funded by the National Institute for Health Research Health Technology Assessment programme (Project number 11/36/29)

Background. Patient specific instrumentation (PSI) for total knee replacement (TKR) has demonstrated mixed success in simplifying the operation, reducing its costs, and improving limb alignment. Evaluation of PSI with tools such as radiostereometric analysis (RSA) has been limited, especially for cut-through style guides providing mechanical alignment. The primary goal of the present study was to compare implant migration following TKR using conventional and PSI surgical techniques, with secondary goals to examine whether the use of PSI reduces operative time, instrumentation, and surgical waste. Methods. The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and conventional groups, powered for the RSA analysis. Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical alignment. All patients received the same posterior-stabilized implant, with marker beads inserted in the bone around the implants to enable RSA imaging. Intraoperative variables such as time, number of instrumentation trays used, and mass of surgical waste were recorded. Patients underwent supine RSA exams at multiple time points (2&6 weeks, 3&6 months and yearly) with 6 months data currently available. Migration of the tibial and femoral components was calculated using model-based RSA software. WOMAC, SF-12, EQ5D, and UCLA outcome measures were recorded pre-operatively and post-operatively. Results. There were no demographic differences between groups. One patient in the PSI group was revised for infection, and three patients required manipulation, with no revisions or manipulations in the conventional group. There was no difference in maximum total point motion between groups for the tibia (mean 0.50 vs. 0.50 mm, p = 0.98) or femur (mean 0.46 vs. 0.48 mm, p = 0.87). The PSI group displayed greater tibial posterior tilt (p = 0.048, Fig. 1) and greater femoral anterior tilt (p = 0.01) and valgus rotation (p = 0.04, Fig. 2) than the conventional group, but there were no other differences in migrations. The PSI group required less instrument trays than the conventional group (mean 4.8 vs. 8.1 trays, p < 0.0001), but procedure time was equivalent (mean 79 vs. 74 min, p = 0.06). The PSI group produced less recyclable waste (mean 0.3 vs. 1.4 kg, p < 0.001), but total waste (Fig. 3) was equivalent between groups (mean 10.1 vs. 10.6 kg, p = 0.32). At 6 months there was no difference between groups for SF-12, WOMAC, EQ5D, or UCLA scores. Discussion. At early RSA follow-up, the two groups were broadly similar in implant fixation except for small rotational changes in the tibial and femoral components. The PSI group provided minimal or no advantage over the conventional group for operative time, instrumentation used, or surgical waste produced. The observed increase in manipulations in the PSI group is concerning, and requires additional investigation. Further radiographic and economic analysis is underway to determine if there is any benefit to the use of PSI for TKR during the perioperative and early follow-up period. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

There is a lack of evidence as to the best way to deliver rehabilitation following TKA. Previous work has suggested that postoperative physiotherapy applied to all patients is not effective at improving one-year post-surgical outcomes. The aim of this study was to target physiotherapy to those at risk of poor outcome following TKA, and to determine if a therapist-led intervention offered superior results compared to a home-exercise based protocol in this ‘at risk’ group. The Targeted Rehabilitation to Improve Outcomes (TRIO) study was a prospective randomised controlled trial run at 15-centres in the UK. Patients were identified as ‘potential poor outcome’ based on an Oxford Knee Score (OKS) classification at 6-weeks post-surgery and randomised to either therapist-led or home-exercise based protocols. Patients were reviewed by a physiotherapist and commenced 18-exercise sessions over 6-weeks. The therapist-led group undertook a progressive functional protocol (modified weekly in 1-1 contact sessions) in contrast to the static home-exercise based regime. Evaluation took place following rehabilitation intervention, then at 6-months and 1-year post-surgery. Primary outcome was comparative group OKS at 1-year. Secondary outcomes included, ‘worst’ and ‘average’ pain scores, OXS and EQ-5D, and satisfaction questionnaire. Health economic (cost-utility) analysis was undertaken from NHS perspective up to 1-year post-surgery. Incremental cost per Quality Adjusted Life Years (QALYs) were calculated from intervention costs, patient reported primary and secondary care usage, and EQ-5D data. 4264 patients were screened, 1296 were eligible, 334 patients were randomised, 8 were lost to follow-up, therapy compliance was >85%. Clinically meaningful improvement in OKS (between baseline and 1-year) was seen in both arms (p < 0 .001). Between group difference in 1-year OKS was 1.91 (95%CI, −0.17–3.99) points favouring the therapist-led arm (p=0.07). Incorporating all time point data, between group difference in OKS was 2.25 points (95%CI, 0.61–3.90, p=0.008). Small, non-significant reductions (< 5 %) in both worst and average pain scores were observed favouring the therapist-led group. Enhanced satisfaction with pain relief (OR 1.65, p < 0 .02), ability to perform daily functional tasks (OR 1.66, p < 0 .02), and perform heavy functional tasks (OR 1.6, p=0.04) was reported in the therapist-led group. There was a small non-significant difference of 0.02 points (95%CI −0.02–0.06) between groups in EQ-5D, resulting in a £12,125 cost per QALY of delivering the therapist led intervention with a 57% chance of being cost-effective at the standard UK policy threshold of £20,000 per QALY. TRIO is the largest randomised trial of physiotherapy following TKA, and the first to target rehabilitation to patients at risk of poor outcomes. Both therapist-led and home-exercise based rehabilitation groups made clinically meaningful improvements in outcome by 1-year. We observed a modest difference in OKS in favour of therapist-led rehabilitation compared to the home-exercises which was not statistically significant. The relatively tight confidence intervals suggests that any difference which might exist is too small to be clinically relevant. Patient satisfaction with outcome was however higher in those that received greater physiotherapist contact. While cost per QALY estimates were below UK policy threshold, this result is uncertain and insufficient to make accept-decline recommendations

The imminent introduction of the new Trauma & Orthopaedic (T&O) curriculum, and the implementation of the Improving Surgical Training initiative, reflect yet another paradigm shift in the recent history of trauma and orthopaedic training. The move to outcome-based training without time constraints is a radical departure from the traditional time-based structure and represents an exciting new training frontier. This paper summarizes the history of T&O training reform, explains the rationale for change, and reflects on lessons learnt from the past.

Cite this article: Bone Jt Open 2021;2-3:181–190.

Introduction

Virtual fracture clinics (VFCs) are being increasingly used to offer safe and efficient orthopaedic review without the requirement for face-to-face contact. With the onset of the COVID-19 pandemic, we sought to develop an online referral pathway that would allow us to provide definitive orthopaedic management plans and reduce face-to-face contact at the fracture clinics.

We examined the rates of infection and colonisation by methicillin-resistant Staphylococcus aureus (MRSA) between January 2003 and May 2004 in order to assess the impact of the introduction of an MRSA policy in October 2003, which required all admissions to be screened. Emergency admissions were treated prophylactically and elective beds ring-fenced. A total of 5594 admissions were cross-referenced with 22 810 microbiology results. The morbidity, mortality and cost of managing MRSA-carrying patients, with a proximal fracture of the femur were compared, in relation to age, gender, American Society of Anaesthesiologists grade and residential status, with a group of matched controls who were MRSA-negative.

In 2004, we screened 1795 of 1796 elective admissions and MRSA was found in 23 (1.3%). We also screened 1122 of 1447 trauma admissions and 43 (3.8%) were carrying MRSA. All ten ward transfers were screened and four (40%) were carriers (all p < 0.001). The incidence of MRSA in trauma patients increased by 2.6% per week of inpatient stay (r = 0.97, p < 0.001). MRSA developed in 2.9% of trauma and 0.2% of elective patients during that admission (p < 0.001). The implementation of the MRSA policy reduced the incidence of MRSA infection by 56% in trauma patients (1.57% in 2003 (17 of 1084) to 0.69% in 2004 (10 of 1447), p = 0.035). Infection with MRSA in elective patients was reduced by 70% (0.56% in 2003 (7 of 1257) to 0.17% in 2004 (3 of 1806), p = 0.06). The cost of preventing one MRSA infection was £3200.

Although colonisation by MRSA did not affect the mortality rate, infection by MRSA more than doubled it. Patients with proximal fractures of the femur infected with MRSA remained in hospital for 50 extra days, had 19 more days of vancomycin treatment and 26 more days of vacuum-assisted closure therapy than the matched controls. These additional costs equated to £13 972 per patient.

From this experience we have been able to describe the epidemiology of MRSA, assess the impact of infection-control measures on MRSA infection rates and determine the morbidity, mortality and economic cost of MRSA carriage on trauma and elective orthopaedic wards.