Aims. This study, using a surgeon-maintained database, aimed to explore the risk factors for surgery-related complications in patients undergoing primary cervical spine surgery for degenerative diseases. Methods. We studied 5,015 patients with degenerative cervical diseases who underwent primary cervical spine surgery from 2012 to 2018. We investigated the effects of diseases, surgical procedures, and patient demographics on surgery-related complications. As subcategories, the presence of cervical kyphosis ≥ 10°, the presence of ossification of the posterior longitudinal ligament (OPLL) with a canal-occupying ratio ≥ 50%, and foraminotomy were selected. The surgery-related complications examined were postoperative upper limb palsy (ULP) with a manual muscle test (MMT) grade of 0 to 2 or a reduction of two grade or more in the MMT, neurological deficit except ULP, dural tear, dural leakage, surgical-site infection (SSI), and postoperative haematoma. Multivariate logistic regression analysis was performed. Results. The significant risk factors (p < 0.050) for ULP were OPLL (odds ratio (OR) 1.88, 95% confidence interval (CI) 1.29 to 2.75), foraminotomy (OR 5.38, 95% CI 3.28 to 8.82), old age (per ten years, OR 1.18, 95% CI 1.03 to 1.36), anterior spinal fusion (OR 2.85, 95% CI 1.53 to 5.34), and the number of operated levels (OR 1.25, 95% CI 1.11 to 1.40). OPLL was also a risk factor for neurological deficit except ULP (OR 5.84, 95% CI 2.80 to 12.8), dural tear (OR 1.94, 95% CI 1.11 to 3.39), and dural leakage (OR 3.15, 95% CI 1.48 to 6.68). Among OPLL patients, dural tear and dural leakage were frequently observed in those with a canal-occupying ratio ≥ 50%. Cervical rheumatoid arthritis (RA) was a risk factor for SSI (OR 10.1, 95% CI 2.66 to 38.4). Conclusion. The high risk of ULP, neurological deficit except ULP, dural tear, and dural leak should be acknowledged by clinicians and OPLL patients, especially in those patients with a canal-occupying ratio ≥ 50%. Foraminotomy and RA were dominant risk factors for ULP and SSI, respectively. An awareness of these risks may help surgeons to avoid surgery-related complications in these conditions. Cite this article: Bone Joint J 2021;103-B(1):157–163

Aims. Total joint replacement (TJR) is a high-cost, high-volume procedure that impacts patients’ quality of life. Informed decisions are important for patients facing TJR. The quality of information provided by websites regarding TJR is highly variable. We aimed to measure the quality of TJR information online. Methods. We identified 10,800 websites using 18 TJR-related keywords (conditions and procedures) across the Australian, French, German and Spanish Google search engines. We used the Health on the Net (HON) toolbar to evaluate the first 150 websites downloaded for every keyword in each language. The quality of information on websites was inspected, accounting for differences by language and tertiles. We also undertook an analysis of English websites to explore types of website providers. Results. ‘Total joint replacement’ had the most results returned (150 million websites), and 9% of websites are HON-accredited. Differences in information quality were seen across search terms (p < 0.001) and tertiles (p < 0.001), but not between languages (p = 0.226). A larger proportion of HON-accredited websites were seen from keywords in the condition and arthroplasty categories. The first tertile contained the highest number of HON-accredited websites for the majority of search terms. Government/educational bodies sponsored the majority of websites. Conclusion. Clinicians must consider the shortage of websites providing validated information, with disparities in both number and quality of websites for TJR conditions and procedures. As such, the challenge for clinicians is to lead the design of reliable, accurate and ethical orthopaedic websites online and direct patients to them. This stands to reward both parties greatly

Aims. The James Lind Alliance aims to bring patients, carers, and clinicians together to identify uncertainties regarding care. A Priority Setting Partnership was established by the British Association for Surgery of the Knee in conjunction with the James Lind Alliance to identify research priorities related to the assessment, management, and rehabilitation of patients with persistent symptoms after knee arthroplasty. Methods. The project was conducted using the James Lind Alliance protocol. A steering group was convened including patients, surgeons, anaesthetists, nurses, physiotherapists, and researchers. Partner organizations were recruited. A survey was conducted on a national scale through which patients, carers, and healthcare professionals submitted key unanswered questions relating to problematic knee arthroplasties. These were analyzed, aggregated, and synthesized into summary questions and the relevant evidence was checked. After confirming that these were not answered in the current literature, 32 questions were taken forward to an interim prioritization survey. Data from this survey informed a shortlist taken to a final consensus meeting. Results. A total of 769 questions were received during the initial survey with national reach across the UK. These were refined into 32 unique questions by an independent information specialist. The interim prioritization survey was completed by 201 respondents and 25 questions were taken to a final consensus group meeting between patients, carers, and healthcare professionals. Consensus was reached for ranking the top ten questions for publication and dissemination. Conclusions. The top ten research priorities focused on pain, infection, stiffness, health service configuration, surgical and non-surgical management strategies, and outcome measures. This list will guide funders and help focus research efforts within the knee arthroplasty community. Cite this article: Bone Joint J 2020;102-B(9):1176–1182

Aims. Slipped capital femoral epiphysis (SCFE) is one of the most common hip diseases of adolescence that can cause marked disability, yet there is little robust evidence to guide treatment. Fundamental aspects of the disease, such as frequency, are unknown and consequently the desire of clinicians to undertake robust intervention studies is somewhat prohibited by a lack of fundamental knowledge. Methods. The study is an anonymized nationwide comprehensive cohort study with nested consented within the mechanism of the British Orthopaedic Surgery Surveillance (BOSS) Study. All relevant hospitals treating SCFE in England, Scotland, and Wales will contribute anonymized case details. Potential missing cases will be cross-checked against two independent external sources of data (the national administrative data and independent trainee data). Patients will be invited to enrich the data collected by supplementing anonymized case data with patient-reported outcome measures. In line with recommendations of the IDEAL Collaboration, the study will primarily seek to determine incidence, describe case mix and variations in surgical interventions, and explore the relationships between baseline factors (patients and types of interventions) and two-year outcomes. Discussion. This is the first disease to be investigated using the BOSS Study infrastructure. It provides a robust method to determine the disease frequency, and a large unbiased sample of cases from which treatment strategies can be investigated. It may form the basis for definitive robust intervention studies or, where these are demonstrated not to be feasible, this may be the most robust cohort study

Aims. This study presents patient-reported quality of life (QoL) over the first year following surgical debridement of long bone osteomyelitis. It assesses the bone involvement, antimicrobial options, coverage of soft tissues, and host status (BACH) classification as a prognostic tool and its ability to stratify cases into ‘uncomplicated’ or ‘complex’. Methods. Patients with long-bone osteomyelitis were identified prospectively between June 2010 and October 2015. All patients underwent surgical debridement in a single-staged procedure at a specialist bone infection unit. Self-reported QoL was assessed prospectively using the three-level EuroQol five-dimension questionnaire (EQ-5D-3L) index score and visual analogue scale (EQ-VAS) at five postoperative time-points (baseline, 14 days, 42 days, 120 days, and 365 days). BACH classification was applied retrospectively by two clinicians blinded to outcome. Results. In total, 71 patients with long-bone osteomyelitis were included. There was significant improvement from time of surgery to one year postoperatively in mean EQ-VAS (58.2 to 78.9; p < 0.001) and mean EQ-5D-3L index scores (0.284 to 0.740; p < 0.001). At one year following surgery, BACH ‘uncomplicated’ osteomyelitis was associated with better QoL compared to BACH ‘complex’ osteomyelitis (mean EQ-5D-3L 0.900 vs 0.685; p = 0.020; mean EQ-VAS 87.1 vs 73.6; p = 0.043). Patients with uncomplicated bone involvement (BACH type B1, cavitary) reported higher QoL at all time-points when compared to complex bone involvement (B2, segmental or B3, osteomyelitis involving a joint). Patients with good antimicrobial options (Ax or A1) gave higher outcome scores compared to patients with multidrug-resistant isolates (A2). The need for microvascular tissue transfer (C1 and C2) did not impact significantly on QoL. Patients without major comorbidities (uncomplicated, H1) reported higher QoL compared to those with significant disease (complex, H2). Conclusion. Uncomplicated osteomyelitis, as defined by BACH, gave higher self-reported QoL when compared to complex cases. The bone involvement, antimicrobial options, and host status variables were able to stratify patients in terms of QoL. These data can be used to offer prognostic information to patients who are undergoing treatment for long bone osteomyelitis. Cite this article: Bone Joint J 2020;102-B(11):1587–1596

Aims. Routine surveillance of primary hip and knee arthroplasties has traditionally been performed with office follow-up visits at one year postoperatively. The value of these visits is unclear. The present study aims to determine the utility and burden of routine clinical follow-up at one year after primary arthroplasty to patients and providers. Methods. All patients (473) who underwent primary total hip (280), hip resurfacing (eight), total knee (179), and unicompartmental knee arthroplasty (six) over a nine-month period at a single institution were identified from an institutional registry. Patients were prompted to attend their routine one-year postoperative visit by a single telephone reminder. Patients and surgeons were given questionnaires at the one-year postoperative visit, defined as a clinical encounter occurring at nine to 15 months from the date of surgery, regarding value of the visit. Results. Compliance with routine follow-up at one year was 35%. The response rate was over 80% for all questions in the patient and clinician surveys. Overall, 75% of the visits were for routine surveillance. Patients reported high satisfaction with their visits despite the general time for attendance, including travel, being over four hours. Surgeons found the visits more worthwhile when issues were identified or problems were addressed. Conclusion. Patient compliance with follow-up at one year postoperatively after primary hip and knee is low. Routine visits of asymptomatic patients deliver little practical value and represent a large time and cost burden for patients and surgeons. Remote strategies should be considered for routine postoperative surveillance primary hip and knee arthroplasties beyond the acute postoperative period. Cite this article: Bone Joint J 2020;102-B(7 Supple B):85–89

Aims. To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods. The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results. In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion. Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617

It is unusual, if not unique, for three major research papers concerned with the management of the fractured neck of femur (FNOF) to be published in a short period of time, each describing large prospective randomized clinical trials. These studies were conducted in up to 17 countries worldwide, involving up to 80 surgical centers and include large numbers of patients (up to 2,900) with FNOF. Each article investigated common clinical dilemmas; the first paper comparing total hip arthroplasty versus hemiarthroplasty for FNOF, the second as to whether ‘fast track’ care offers improved clinical outcomes and the third, compares sliding hip with multiple cancellous hip screws. Each paper has been deemed of sufficient quality and importance to warrant publication in The Lancet or the New England Journal of Medicine. Although ‘premier’ journals, they only occationally contain orthopaedic studies and thus may not be routinely read by the busy orthopaedic/surgical clinician of any grade. It is therefore our intention with this present article to accurately summarize and combine the results of all three papers, presenting, in our opinion, the most important clinically relevant facts. Cite this article: Bone Joint Open 2020;1-6:198–202

Aims. To calculate how the likelihood of obtaining measurable benefit from hip or knee arthroplasty varies with preoperative patient-reported scores. Methods. Existing UK data from 222,933 knee and 209,760 hip arthroplasty patients were used to model an individual’s probability of gaining meaningful improvement after surgery based on their preoperative Oxford Knee or Hip Score (OKS/OHS). A clinically meaningful improvement after arthroplasty was defined as ≥ 8 point improvement in OHS, and ≥ 7 in OKS. Results. The upper preoperative score threshold, above which patients are unlikely to achieve any meaningful improvement from surgery, is 41 for knees and 40 for hips. At lower scores, the probability of improvement increased towards a maximum of 88% (knee) and 95% for (hips). Conclusion. By our definition of meaningful improvement, patients with preoperative scores above 41 (OKS) and 40 (OHS) should not be routinely referred to secondary care for possible arthroplasty. Using lower thresholds would incrementally increase the probability of meaningful benefit for those referred but will exclude some patients with potential to benefit. The findings are useful to support the complex shared decision-making process in primary care for referral to secondary care; and in secondary care for experienced clinicians counselling patients considering knee or hip arthroplasty, but should not be used in isolation. Cite this article: Bone Joint J 2020;102-B(7):941–949

Aims. The aim of this study was to develop a novel computational model for estimating head/stem taper mechanics during different simulated assembly conditions. Methods. Finite element models of generic cobalt-chromium (CoCr) heads on a titanium stem taper were developed and driven using dynamic assembly loads collected from clinicians. To verify contact mechanics at the taper interface, comparisons of deformed microgroove characteristics (height and width of microgrooves) were made between model estimates with those measured from five retrieved implants. Additionally, these models were used to assess the role of assembly technique—one-hit versus three-hits—on the taper interlock mechanical behaviour. Results. The model compared well to deformed microgrooves from the retrieved implants, predicting changes in microgroove height (mean 1.1 μm (0.2 to 1.3)) and width (mean 7.5 μm (1.0 to 18.5)) within the range of measured changes in height (mean 1.4 μm (0.4 to 2.3); p = 0.109) and width (mean 12.0 μm (1.5 to 25.4); p = 0.470). Consistent with benchtop studies, our model found that increasing assembly load magnitude led to increased taper engagement, contact pressure, and permanent deformation of the stem taper microgrooves. Interestingly, our model found assemblies using three hits at low loads (4 kN) led to decreased taper engagement, contact pressures and microgroove deformations throughout the stem taper compared with tapers assembled with one hit at the same magnitude. Conclusion. These findings suggest additional assembly hits at low loads lead to inferior taper interlock strength compared with one firm hit, which may be influenced by loading rate or material strain hardening. These unique models can estimate microgroove deformations representative of real contact mechanics seen on retrievals, which will enable us to better understand how both surgeon assembly techniques and implant design affect taper interlock strength. Cite this article: Bone Joint J 2020;102-B(7 Supple B):33–40

Cementless knee arthroplasty has seen a recent resurgence in popularity due to conceptual advantages, including improved osseointegration providing biological fixation, increased surgical efficiency, and reduced systemic complications associated with cement impaction and wear from cement debris. Increasingly younger and higher demand patients are requiring knee arthroplasty, and as such, there is optimism cementless fixation may improve implant survivorship and functional outcomes. Compared to cemented implants, the National Joint Registry (NJR) currently reports higher revision rates in cementless total knee arthroplasty (TKA), but lower in unicompartmental knee arthroplasty (UKA). However, recent studies are beginning to show excellent outcomes with cementless implants, particularly with UKA which has shown superior performance to cemented varieties. Cementless TKA has yet to show long-term benefit, and currently performs equivalently to cemented in short- to medium-term cohort studies. However, with novel concepts including 3D-printed coatings, robotic-assisted surgery, radiostereometric analysis, and kinematic or functional knee alignment principles, it is hoped they may help improve the outcomes of cementless TKA in the long-term. In addition, though cementless implant costs remain higher due to novel implant coatings, it is speculated cost-effectiveness can be achieved through greater surgical efficiency and potential reduction in revision costs. There is paucity of level one data on long-term outcomes between fixation methods and the cost-effectiveness of modern cementless knee arthroplasty. This review explores recent literature on cementless knee arthroplasty, with regards to clinical outcomes, implant survivorship, complications, and cost-effectiveness; providing a concise update to assist clinicians on implant choice. Cite this article: Bone Jt Open 2021;2(1):48–57

Aims. The COVID-19 pandemic presents an unprecedented burden on global healthcare systems, and existing infrastructures must adapt and evolve to meet the challenge. With health systems reliant on the health of their workforce, the importance of protection against disease transmission in healthcare workers (HCWs) is clear. This study collated responses from several countries, provided by clinicians familiar with practice in each location, to identify areas of best practice and policy so as to build consensus of those measures that might reduce the risk of transmission of COVID-19 to HCWs at work. Methods. A cross-sectional descriptive survey was designed with ten open and closed questions and sent to a representative sample. The sample was selected on a convenience basis of 27 senior surgeons, members of an international surgical society, who were all frontline workers in the COVID-19 pandemic. This study was reported according to the Standards for Reporting Qualitative Research (SRQR) checklist. Results. Responses were received by all 27 surgeons from 22 countries across six continents. A number of the study respondents reported COVID-19-related infection and mortality in HCWs in their countries. Differing areas of practice and policy were identified and organized into themes including the specification of units receiving COVID-19 patients, availability and usage of personal protective equipment (PPE), other measures to reduce staff exposure, and communicating with and supporting HCWs. Areas more specific to surgery also identified some variation in practice and policy in relation to visitors to the hospital, the outpatient department, and in the operating room for both non-urgent and emergency care. Conclusion. COVID-19 presents a disproportionate risk to HCWs, potentially resulting in a diminished health system capacity, and consequently an impairment to population health. Implementation of these recommendations at an international level could provide a framework to reduce this burden

Aims. The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. Patients and Methods. Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury. Results. Of 36 patients who met the inclusion criteria, five declined to participate and eight were not recruited, leaving 23 patients to be randomized. One patient withdrew before surgery. Of the remaining patients, five (23%) withdrew during the follow-up period and six (26%) died. A 100% response rate was achieved for the EQ-5D at each follow-up point, excluding one missing datapoint at baseline. In the DFR group, the mean cost of the implant outweighed the mean cost of many other items, including theatre time, length of stay, and readmissions. For a powered RCT, a total sample size of 1400 would be required with 234 centres recruiting over three years. At six months, the EQ-5D utility index was lower in the DFR group. Conclusion. This study found that running a full-scale trial in this country would not be feasible. However, it may be feasible to undertake an international multicentre trial, and our findings provide some guidance about the power of such a study, the numbers required, and some challenges that should be anticipated and addressed. Cite this article: Bone Joint J 2019;101-B:1408–1415

Aims. Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees. Methods. A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed. Results. There were 22 periprosthetic fractures; they occurred exclusively in the femur: two in the femoral neck, 14 intertrochanteric and six subtrochanteric, representing 4.2% of 518 osseointegration operations and 6.3% of 347 femoral implants. The vast majority (19/22, 86.4%) occurred within 2 cm of the proximal tip of the implant and after a fall. No fractures occurred spontaneously. Fixation most commonly involved dynamic hip screws (10) and reconstruction plates (9). No osseointegration implants required removal, the K-level was not reduced after fixation of the fracture in any patient, and all retained a K-level of ≥ 2. All fractures united, 21 out of 22 patients (95.5%) wear their osseointegration-mounted prosthetic limb longer daily than when using a socket, with 18 out of 22 (81.8%) reporting using it for ≥ 16 hours daily. Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046). No increased risk was identified for bilateral implants (p = 0.083), time from amputation to osseointegration (p = 0.974), age at osseointegration (p = 0.331), or bone density (g/cm2, p = 0.560; T-score, p = 0.247; Z-score, p = 0.312). Conclusion. The risks and sequelae of periprosthetic fracture after press-fit osseointegration for amputation should not deter patients or clinicians from considering this procedure. Females and heavier patients are likely to have an increased risk of fracture. Age, years since amputation, and bone density do not appear influential. Cite this article: Bone Joint J 2020;102-B(2):162–169

Aims. With recent progress in cancer treatment, the number of advanced-age patients with spinal metastases has been increasing. It is important to clarify the influence of advanced age on outcomes following surgery for spinal metastases, especially with a focus on subjective health state values. Methods. We prospectively analyzed 101 patients with spinal metastases who underwent palliative surgery from 2013 to 2016. These patients were divided into two groups based on age (< 70 years and ≥ 70 years). The Eastern Cooperative Oncology Group (ECOG) performance status (PS), Barthel index (BI), and EuroQol-5 dimension (EQ-5D) score were assessed at study enrolment and at one, three, and six months after surgery. The survival times and complications were also collected. Results. In total, 65 patients were aged < 70 years (mean 59.6 years; 32 to 69) and 36 patients were aged ≥ 70 years (mean 75.9 years; 70 to 90). In both groups, the PS improved from PS3 to PS1 by spine surgery, the mean BI improved from < 60 to > 80 points, and the mean EQ-5D score improved from 0.0 to > 0.7 points. However, no significant differences were found in the improvement rates and values of the PS, BI, and EQ-5D score at any time points between the two groups. The PS, BI, and EQ-5D score improved throughout the follow-up period in approximately 90% of patients in each group. However, the improved PS, BI, and EQ-5D scores subsequently deteriorated in some patients, and the redeterioration rate of the EQ-5D was significantly higher in patients aged ≥ 70 than < 70 years (p = 0.027). Conclusion. Palliative surgery for spinal metastases improved the PS, activities of daily living, and quality of life, regardless of age. However, clinicians should be aware of the higher risk of redeterioration of the quality of life in advanced-age patients. Cite this article: Bone Joint J 2020;102-B(12):1709–1716

Aims. The aim of this study was to review the value of accepting referrals for children with ‘clicky hips’ in a selective screening programme for hip dysplasia. Patients and Methods. A single-centre prospective database of all referrals to the hip clinic was examined to identify indication for referrals, diagnosis, and treatment. All patients referred received a standardized ultrasound scan and clinical examination by an orthopaedic consultant. Results. There were 5716 children referred to the orthopaedic hip clinic between 1 June 2014 and 26 September 2018. In all, 1754 children (30.1%) were referred due to ‘clicky hip’ with no additional risk factors or indications for ultrasound scan. A total of 123 children (7.1%) referred with ‘clicky hip’ and no additional risk factors or examination findings had an abnormal initial hip ultrasound, including 16 children (0.9%) with dysplastic hips. Of the 141 children who required treatment in a Pavlik harness during the study period, 23 (16%) had been referred with a ‘clicky hip’ and no additional risk factors or examination findings, including six children with Graf 3 or 4 hips. Conclusion. There is significant value in reviewing children with an isolated ‘clicky hip’. Many children who require treatment are referred to the orthopaedic service as ‘clicky hip’ with no additional risk factors. In a pragmatic pathway with a diverse population of clinicians performing baby checks, ‘clicky hip’ is an important indication for referral and should not be discarded. Cite this article: Bone Joint J 2019;101-B:635–638

Aims. To establish the utility of adding the laboratory-based synovial alpha-defensin immunoassay to the traditional diagnostic work-up of a prosthetic joint infection (PJI). Methods. A group of four physicians evaluated 158 consecutive patients who were worked up for PJI, of which 94 underwent revision arthroplasty. Each physician reviewed the diagnostic data and decided on the presence of PJI according to the 2014 Musculoskeletal Infection Society (MSIS) criteria (yes, no, or undetermined). Their initial randomized review of the available data before or after surgery was blinded to each alpha-defensin result and a subsequent randomized review was conducted with each result. Multilevel logistic regression analysis assessed the effect of having the alpha-defensin result on the ability to diagnose PJI. Alpha-defensin was correlated to the number of synovial white blood cells (WBCs) and percentage of polymorphonuclear cells (%PMN). Results. Intraobserver reliability and interobserver agreement did not change when the alpha-defensin result was available. Positive alpha-defensin results had greater synovial WBCs (mean 31,854 cells/μL, SD 32,594) and %PMN (mean 93.0%, SD 5.5%) than negative alpha-defensin results (mean 974 cells/μL, SD 3,988; p < 0.001 and mean 39.4% SD 28.6%; p < 0.001). Adding the alpha-defensin result did not alter the diagnosis of a PJI using preoperative (odds ratio (OR) 0.52, 95% confidence interval (CI) 0.14 to 1.88; p = 0.315) or operative (OR 0.52, CI 0.18 to 1.55; p = 0.242) data when clinicians already decided that PJI was present or absent with traditionally available testing. However, when undetermined with traditional preoperative testing, alpha-defensin helped diagnose (OR 0.44, CI 0.30 to 0.64; p < 0.001) or rule out (OR 0.41, CI 0.17 to 0.98; p = 0.044) PJI. Of the 27 undecided cases with traditional testing, 24 (89%) benefited from the addition of alpha-defensin testing. Conclusion. The laboratory-based synovial alpha-defensin immunoassay did not help diagnose or rule out a PJI when added to routine serologies and synovial fluid analyses except in cases where the diagnosis of PJI was unclear. We recommend against the routine use of alpha-defensin and suggest using it only when traditional testing is indeterminate. Cite this article: Bone Joint J 2020;102-B(5):593–599

Health economic evaluations potentially provide valuable information to clinicians, health care administrators, and policy makers regarding the financial implications of decisions about the care of patients. The highest quality research should be used to inform decisions that have direct impact on the access to care and the outcome of treatment. However, economic analyses are often complex and use research methods which are relatively unfamiliar to clinicians. Furthermore, health economic data have substantial national, regional, and institutional variability, which can limit the external validity of the results of a study. Therefore, minimum guidelines that aim to standardise the quality and transparency of reporting health economic research have been developed, and instruments are available to assist in the assessment of its quality and the interpretation of results. The purpose of this editorial is to discuss the principal types of health economic studies, to review the most common instruments for judging the quality of these studies and to describe current reporting guidelines. Recommendations for the submission of these types of studies to The Bone & Joint Journal are provided. Cite this article: Bone Joint J 2016;98-B:147–51

Stem cells are defined by their potential for self-renewal and the ability to differentiate into numerous cell types, including cartilage and bone cells. Although basic laboratory studies demonstrate that cell therapies have strong potential for improvement in tissue healing and regeneration, there is little evidence in the scientific literature for many of the available cell formulations that are currently offered to patients. Numerous commercial entities and ‘regenerative medicine centres’ have aggressively marketed unproven cell therapies for a wide range of medical conditions, leading to sometimes indiscriminate use of these treatments, which has added to the confusion and unpredictable outcomes. The significant variability and heterogeneity in cell formulations between different individuals makes it difficult to draw conclusions about efficacy. The ‘minimally manipulated’ preparations derived from bone marrow and adipose tissue that are currently used differ substantially from cells that are processed and prepared under defined laboratory protocols. The term ‘stem cells’ should be reserved for laboratory-purified, culture-expanded cells. The number of cells in uncultured preparations that meet these defined criteria is estimated to be approximately one in 10 000 to 20 000 (0.005% to 0.01%) in native bone marrow and 1 in 2000 in adipose tissue. It is clear that more refined definitions of stem cells are required, as the lumping together of widely diverse progenitor cell types under the umbrella term ‘mesenchymal stem cells’ has created confusion among scientists, clinicians, regulators, and our patients. Validated methods need to be developed to measure and characterize the ‘critical quality attributes’ and biological activity of a specific cell formulation. It is certain that ‘one size does not fit all’ – different cell formulations, dosing schedules, and culturing parameters will likely be required based on the tissue being treated and the desired biological target. As an alternative to the use of exogenous cells, in the future we may be able to stimulate the intrinsic vascular stem cell niche that is known to exist in many tissues. The tremendous potential of cell therapy will only be realized with further basic, translational, and clinical research. Cite this article: Bone Joint J 2019;101-B:361–364

Cite this article: Bone Joint Res 2023;12(6):372–374.