Obese Patients Achieve Good Improvements in Patient-Reported Outcome Measures After Medial Unicompartmental Knee Arthroplasty Despite a Lower Preoperative Score.

BACKGROUND: In this study, we examined the association between obesity and patient-reported outcome measures after medial unicompartmental knee arthroplasty (MUKA), assessed through score changes, Patient Acceptable Symptom State (PASS), and minimal important change (MIC). Second, the association between obesity and early readmissions was examined. METHODS: A total of 450 MUKAs (mean body mass index [BMI] 30.3, range, 19.6-53.1), performed from February 2016 to December 2020, were grouped using BMI: <30, 30-34.9, and >34.9. Oxford Knee Score (OKS), Forgotten Joint Score (FJS), and Activity and Participation Questionnaire (APQ) were assessed preoperatively and at 3, 12, and 24 months, postoperatively. The 12-month PASS and MIC were also assessed, defining PASS as OKS = 30, MIC-OKS as change in OKS = 8, and MIC-FJS as change in FJS = 14. RESULTS: No significant differences in OKS change were found between BMI groups. After 12 months, patients who had a BMI of 30-34.9 had lower change in FJS (estimate -8.1, 95% CI -14.9 to -1.4) and were less likely to reach PASS (odds ratio 0.4, 95% CI 0.2-0.7) as well as MIC-FJS (odds ratio 0.5, 95% CI 0.2-0.9). Both obese groups had lower change in APQ after 12 months. Differences in 90-day readmission rates were nonsignificant between groups. CONCLUSION: Our findings of no differences in OKS improvement between BMI groups and achieving MIC for BMI > 34.9 suggest good improvements in obese patients despite lower preoperative scores, supporting contemporary indications for MUKA. Lower APQ development and achievement of 12-month PASS may be used when addressing expectations of recovery.

Use of a tourniquet is not associated with increased risk of venous thromboembolism after fast-track total knee arthroplasty: a prospective multicenter cohort study of 16,250 procedures.

BACKGROUND AND PURPOSE: Venous thromboembolism (VTE) is a serious postoperative complication after total knee arthroplasty (TKA). Use of a tourniquet has shown conflicting results for risk of VTE after TKA. We aimed to investigate the associated risk of VTE after TKA using tourniquet in a fast-track set-up as no previous data exists. PATIENTS AND METHODS: We performed an observational cohort study from 9 fast-track centers including unilateral primary TKA from 2010-2017 with prospective collection of preoperative risk-factors and complete 90-day follow-up. Use of a tourniquet was registered in the Danish Knee Arthroplasty Register. Postoperative VTE was identified from health records. We performed risk analyses using a mixed-effects logistic regression model adjusting for previously identified risk factors. RESULTS: Of the 16,250 procedures (39% males, mean age 67.9 [SD 10.0] years, median LOS 2 [interquartile range 2-3]) 12,518 (77%) were performed with a tourniquet. The annual tourniquet usage varied greatly between departments from 0% to 100%, but also within departments from 0% to 99%. There was no significant difference between the 2 groups with 52 (0.42%) VTEs in the tourniquet group vs. 25 (0.67%) in the no-tourniquet group (p = 0.06 for cumulative 90-day incidence of VTE). This association remained statistically insignificant for VTE using tourniquet after adjustment for previously identified risk factors. CONCLUSION: We found no association between the use of a tourniquet and increased risk of 90-day VTE after primary fast-track TKA, irrespective of the length of time for which the tourniquet was applied.

Optimized medial unicompartmental knee arthroplasty outcome: learning from 20 years of propensity score matched registry data.

BACKGROUND AND PURPOSE: Unicompartmental knee arthroplasty (UKA) has increased in use. We investigated changes to UKA revision risk over the last 20 years compared with total knee arthroplasty (TKA), examined external and patient factors for correlation to UKA revision risk, and described the survival probability for current UKA and TKA practice. PATIENTS AND METHODS: All knee arthroplasties reported to the Danish Knee Arthroplasty Register from 1997 to 2017 were linked to the National Patient Register and the Civil Registration System for comorbidity, emigration, and mortality information. All primary UKA and TKA patients with primary osteoarthritis were included and propensity score matched 4 TKAs to 1 UKA. Revision and mortality were analyzed using competing risk cox regression with a shared gamma frailty component. RESULTS: The matched cohort included 48,195 primary knee arthroplasties (9,639 UKAs). From 1997-2001 to 2012-2017 the 3-year hazard ratio decreased from 5.5 (95% CI 2.7-11) to 1.5 (CI 1.2-1.8) due to increased UKA survival. Cementless fixation, a high percentage usage of UKA, and increased surgical volume decreased UKA revision risk, and increased in occurrence parallel to the decreasing revision risks. Current UKA practice using cementless fixation at a high usage unit has a 3-year implant survival of 96% (CI 97-95), 1.1% lower than current TKA practice. INTERPRETATION: UKA revision risk has decreased over the last 20 years, nearing that of TKA surgery. High usage rates, surgical volume, and the use of cementless fixation have increased during the study and were associated with decreased UKA revision risks.

No increase in postoperative contacts with the healthcare system following outpatient total hip and knee arthroplasty.

Background and purpose - Discharge on the day of surgery (DDOS) after total hip arthroplasty (THA) and total knee arthroplasty (TKA) has been shown to be safe in selected patients. Concerns have been raised that discharging patients on the day of surgery (DOS) could lead to an increased burden on other parts of the healthcare system when compared with patients not discharged on the DOS (nDDOS). Therefore, we investigated whether discharging patients on the day of surgery (DOS) after THA and TKA leads to increased contacts with the primary care sector or other departments within the secondary care sector.Patients and methods - Prospective data on 261 consecutive patients scheduled for outpatient THA (n = 135) and TKA (n = 126) were collected as part of a previous cohort study. 33% of THA patients and 37% of TKA patients were discharged on the DOS. Readmissions within 3 months after surgery were recorded. Contacts with the discharging department, other departments, and primary care physicians within 3 weeks were registered.Results - No statistically significant differences were found when comparing DDOS patients and patients not discharged on the DOS (nDDOS) with regard to readmissions, physical contacts with the discharging department, and contacts with other departments as well as general practitioners. THA DDOS patients had significantly fewer contacts with the discharging department by telephone than THA nDDOS patients. TKA DDOS patients had significantly more contacts with the discharging department by telephone than TKA nDDOS patients.Interpretation - Patients discharged on the DOS following THA or TKA generally have similar postoperative contacts with the healthcare system when compared with patients not discharged on the DOS.

Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis.

BACKGROUND: Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. OBJECTIVE: This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. METHODS: Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. RESULTS: In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). CONCLUSIONS: Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.

Patients with anteromedial osteoarthritis achieve the greatest improvement in patient reported outcome after total knee arthroplasty.

The osteoarthritic (OA) disease pattern of the knee is one of the determinants for choice of arthroplasty concept when knee replacement is indicated, but whether the disease pattern has a direct effect on postoperative outcome has not previously been investigated. The aim was to investigate if different OA disease patterns have an effect on postoperative outcome after receiving total knee arthroplasty (TKA). MATERIALS AND METHODS: 472 patients with pre- and 1-year postoperative patient reported outcome measures (PROMs) undergoing TKA surgery were retrospectively identified and classification of the OA disease pattern was made on preoperative radiographs. Measured resection was the universal technical approach. RESULTS: The key findings showed greater improvement in mean PROMs for anteromedial OA (AMOA) compared with other OA disease patterns; 3.1 points (95% CI 1.4-4.7, p < 0.001) in Oxford Knee score, 11.7 points (95% CI 0.9-22.5, p = 0.034) in Forgotten Joint score and 0.08 points (95% CI 0.02-0.14, p = 0.007) in EQ 5D score. Similar results were observed when comparing AMOA with AMOA that had only partial thickness cartilage loss (AMOA-PTCL). CONCLUSIONS: Patients with AMOA achieve greater improvement in PROMs after TKA surgery when using measured resection compared with other OA disease patterns. This finding has important implications for reporting, risk stratification and interpretation in TKA outcome studies, including randomized trials, why further investigation of the topic is of highly relevance.

Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with carboplatin used for ovarian, tubal, and primary peritoneal cancer.

BACKGROUND AND OBJECTIVES: Hypertherm intraperitoneal chemotherapy (HIPEC) is increasingly used in the treatment of ovarian, tubal, and primary peritoneal cancer (OC). The aim was to evaluate short-term morbidity of cytoreductive surgery (CRS) and carboplatin HIPEC. METHODS: Prospective feasibility study performed from January 2016 to December 2017. Twenty-five patients with primary OC (FIGO III-IV) received upfront or interval CRS combined with carboplatin HIPEC at dose 800 mg/m 2 . Primary outcome measurements: grade 3 to 5 adverse events within 30 days according to Common Terminology Criteria for Adverse Events. Secondary outcome measurements: reoperation rate, length of hospital stay, readmission rate, and time from surgery to systemic chemotherapy administration. RESULTS: No deaths (grade 5) or grade 4 adverse events were observed. Eleven patients (44.0%) experienced at least one grade 3 adverse event, the most common being an infection (28.0%) and neutropenia (12.0%). The reoperation rate was 8.0%. The median hospital stay was 14 days (range 9-25 days), and five patients (25.0%) were readmitted within 30 days after surgery. Median time from surgery to the administration of the first dose of systemic chemotherapy was 41 days (range 24-81 days). CONCLUSION: Our small-scale prospective study supports that CRS and carboplatin HIPEC used for primary advanced-stage OC is feasible with acceptable morbidity.

Medial unicompartmental knee arthroplasty: increasingly uniform patient demographics despite differences in surgical volume and usage-a descriptive study of 8,501 cases from the Danish Knee Arthroplasty Registry.

Background and purpose - Using contemporary indications, up to 50% of patients undergoing knee arthroplasty are eligible for unicompartmental knee arthroplasty (UKA), and lower UKA use likely reflects a restrictive approach to patient selection. Since broader indications have been successfully introduced, and low surgical volume and UKA percentage (usage) are associated with higher revision rates, it is of interest whether the actual use of UKA has changed accordingly. We explored this by assessing time trends in patient demographics and whether these are associated with center UKA volume and usage. Patients and methods - From the Danish Knee Arthroplasty Registry, we included 8,501 medial UKAs performed for primary osteoarthritis during 2002-2016. Using locally weighted regression, we examined changes-both overall and by center volume and usage (low vs high)-in sex distribution, age, weight, and preoperative American Knee Society Score (AKSS-O). Results - Over the last 20 years, UKA use in Denmark has been increasing steadily. Age, weight, and proportion of men all increased regardless of volume and usage. AKSS-O showed an initial increase followed by a decrease. In low-usage and low-volume centers, the proportion of women was higher, patients were younger, weighed less, and had higher AKSS-O scores; however, for age and AKSS-O, the groups were converging during the last part of the period. Interpretation - Characteristics of UKA patients have changed in the last 15 years irrespective of center volume and usage. We found between-group differences for both volume and usage, though with convergence for age and AKSS-O, which suggests an increasingly uniform approach to patient selection.

Outcome of a standardized approach to childhood urinary symptoms-long-term follow-up of 720 patients.

AIMS: To investigate the relevance of enuresis subtyping for selection of treatment modality and for long-term outcome in a large consecutive patient cohort. MATERIALS AND METHODS: We included all patients referred for urinary incontinence during a 5-year period but excluding recurrent urinary tract infections (UTI). Type and severity of incontinence, prior history, results of examinations performed, number of visits, and effect of all treatments provided, were included in a clinical database. RESULTS: Seven hundred twenty children aged 4-16 years (mean 8.5 ± 2.2 years, 239 girls) were included in the analysis (42% with monosymptomatic (MNE), 55% with non-MNE, and 3% with isolated daytime incontinence). Initial evaluation revealed only few underlying causes (one neurological and eight anatomical). Investigations showed significant differences between MNE and non-MNE patients as both maximal voided volume and nocturnal urine volume was lower in non-MNE patients (P < 0.001). Follow-up for average 1,587 days (3.4 years) was performed in 660 (92%) patients. A higher number of visits and a longer treatment period were needed for non-MNE patients (on average 4.7 ± 2.8 visits) than MNE patients (3.1 ± 1.6 visits, P < 0.001). The most common treatment regimen that resulted in dryness in both MNE (40%) and non-MNE (36%) was the alarm system. Interestingly, of the 539 patients who initially were referred due to desmopressin resistance 177 (33%) of these were dry on desmopressin monotherapy. CONCLUSIONS: The study indicated that MNE and non-MNE are two distinct disease entities with different optimal treatments and showed that the latter patients are more difficult and time-consuming to manage.

A systematic review of types of healthy eating interventions in preschools.

BACKGROUND: With the worldwide levels of obesity new venues for promotion of healthy eating habits are necessary. Considering children's eating habits are founded during their preschool years early educational establishments are a promising place for making health promoting interventions. METHODS: This systematic review evaluates different types of healthy eating interventions attempting to prevent obesity among 3 to 6 year-olds in preschools, kindergartens and day care facilities. Studies that included single interventions, educational interventions and/or multicomponent interventions were eligible for review. Included studies also had to have conducted both baseline and follow-up measurements.A systematic search of the databases Scopus, Web of Science, CINAHL and PubMed was conducted to identify articles that met the inclusion criteria. The bibliographies of identified articles were also searched for relevant articles. RESULTS: The review identified 4186 articles, of which 26 studies met the inclusion criteria. Fifteen of the interventions took place in preschools, 10 in kindergartens and 1 in another facility where children were cared for by individuals other than their parents. Seventeen of the 26 included studies were located in North America, 1 in South America, 5 in Asia, and 3 in a European context.Healthy eating interventions in day care facilities increased fruit and vegetable consumption and nutrition related knowledge among the target groups. Only 2 studies reported a significant decrease in body mass index. CONCLUSIONS: This review highlights the scarcity of properly designed healthy eating interventions using clear indicators and verifiable outcomes. The potential of preschools as a potential setting for influencing children's food choice at an early age should be more widely recognised and utilised.

Extracted oat and barley ß-glucans do not affect cholesterol metabolism in young healthy adults.

ß-Glucans are known to exhibit hypocholesterolemic effects. Increased intestinal viscosity is thought to be crucial for cholesterol lowering. It is suggested that concentration, molecular mass, and structure, including the ratio of (1→3) to (1→4) glucan bonds in the molecule, are of importance for ß-glucan functionality. This study investigated the effects of 3 different ß-glucan sources, incorporated into a beverage and yogurt, on blood lipids and fecal endpoints. Fourteen participants completed this randomized, crossover, single-blinded study with four 3-wk periods: control and 3.3 g/d oat, barley, and barley mutant ß-glucans of similar molecular mass. Before and after each period, fasting and postprandial blood samples were drawn and 3-d fecal samples were collected. Treatment did not affect changes in total, LDL, and HDL cholesterol compared with control; however, consumption of 3.3 g/d of oat ß-glucans for 3 wk resulted in greater decreases in total (-0.29 ± 0.09 mmol/L, P < 0.01), LDL (-0.23 ± 0.07 mmol/L, P < 0.01), and HDL (-0.05 ± 0.03 mmol/L, P < 0.05) cholesterol compared with baseline. Changes in LDL in the ß-glucan treatments were not related to ß-glucan structure (cellotriosyl:cellotetraosyl). Decreases in fasting triacylglycerol were substantially greater after oat ß-glucan treatment compared with control (P = 0.03). Fecal dry and wet weight, stool frequency, fecal pH, and energy excretion were unaffected. The results do not fully support the hypocholesterolemic effects by differently structured oat and barley ß-glucans. However, substantial differences compared with baseline suggest a potential for oat ß-glucan, presumably due to its higher solubility and viscosity. This underlines the importance of elusive structural ß-glucan features for beneficial physiologic effects.

Identification of interstitial Cajal-like cells in the human thoracic duct.

Interstitial Cajal-like cells (ICLCs) are speculated to be pacemakers in smooth muscle tissues. While the human thoracic duct (TD) is spontaneously active, the origin of this activity is unknown. We hypothesized that ICLCs could be present in the TD and using histological techniques, immunohistochemistry and immunofluorescence we have investigated the presence of ICLCs, protein markers for ICLCs and the cellular morphology of the human TD. Transmission electron microscopy was employed to investigate ultrastructure. Methylene blue staining, calcium-dependent fluorophores and confocal microscopy were used to identify ICLCs in live tissue. Methylene blue stained cells with morphology suggestive of ICLCs in the TD. Immunoreactivity localized the ICLC protein markers c-kit, CD34 and vimentin to many cells and processes associated with smooth muscle cells (SMCs): coexpression of c-kit with vimentin or CD34 was observed in some cells. Electron microscopy analysis confirmed ICLCs as a major cell type of the human TD. Lymphatic ICLCs possess caveolae, dense bands, a patchy basal lamina, intermediate filaments and specific junctions to SMCs. ICLCs were ultrastructurally differentiable from other interstitial cells observed: fibroblasts, mast cells, macrophages and pericytes. Lymphatic ICLCs were localized to the subendothelial region of the wall as well as in intimate association with smooth muscle bundles throughout the media. ICLCs were morphologically distinct with multiple processes and also spindle shapes. Confocal imaging with calcium-dependent fluorophores corroborated cell morphology and localization observed in fixed tissues. Lymphatic ICLCs thus constitute a significant cell type of the human TD and physically interact with lymphatic SMCs.

Does changes in unicompartmental knee arthroplasty practice pattern influence reasons for revision?

Aims: The aim of this study was to describe the pattern of revision indications for unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) and any change to this pattern for UKA patients over the last 20 years, and to investigate potential associations to changes in surgical practice over time. Methods: All primary knee arthroplasty surgeries performed due to primary osteoarthritis and their revisions reported to the Danish Knee Arthroplasty Register from 1997 to 2017 were included. Complex surgeries were excluded. The data was linked to the National Patient Register and the Civil Registration System for comorbidity, mortality, and emigration status. TKAs were propensity score matched 4:1 to UKAs. Revision risks were compared using competing risk Cox proportional hazard regression with a shared γ frailty component. Results: Aseptic loosening (loosening) was the most common revision indication for both UKA (26.7%) and TKA (29.5%). Pain and disease progression accounted for 54.6% of the remaining UKA revisions. Infections and instability accounted for 56.1% of the remaining TKA revision. The incidence of revision due to loosening or pain decreased over the last decade, being the second and third least common indications in 2017. There was a decrease associated with fixation method for pain (hazard ratio (HR) 0.40; 95% confidence interval (CI) 0.17 to 0.94) and loosening (HR 0.29; 95% CI 0.10 to 0.81) for cementless compared to cemented, and units UKA usage for pain (HR 0.67, 95% CI 0.50 to 0.91), and loosening (HR 0.51; 95% CI 0.37 to 0.70) for high usage. Conclusion: The overall revision patterns for UKA and TKA for the last 20 years are comparable to previous published patterns. We found large changes to UKA revision patterns in the last decade, and with the current surgical practice, revision due to pain or loosening are significantly less likely.

Flaxseed dietary fiber supplements for suppression of appetite and food intake.

UNLABELLED: We conducted two single-blinded randomized crossover acute studies with 24 and 20 subjects, respectively, to compare (I) CONTROL vs. Flax drink; and (II) Flax drink vs. Flax tablets. The subjects were exposed to one of the treatments after an overnight fast, and rated appetite sensation for 120 min using visual analog scales (VAS). Hereafter they consumed an ad libitum early lunch to assess energy intake. The treatments were iso-caloric and iso-volumeric: CONTROL: 300 mL drink; Flax drink: CONTROL drink with addition flax fiber extract (2.5 g of soluble fibers); and Flax tablet: CONTROL drink with flax fiber tablets (2.5 g of soluble fibers). Flax drink increased sensation of satiety and fullness compared to CONTROL and a significant decrease in subsequent energy intake was observed after the Flax drink compared to CONTROL (2937 vs. 3214 kJ). Appetite ratings were similar for Flax tablets and Flax drink as they did not differ by more than 1-4%. Subsequent energy intake was similar after the two treatments (3370 vs. 3379 kJ). A small dose of flaxseed fiber significantly suppresses appetite and energy intake. Furthermore, flaxseed fibers administered as drinks or tablets produce similar responses.

Potential for the adoption of measures to reduce N2O emissions from crop residues in Denmark.

Crop residues represent a climate change dilemma: they can promote carbon (C) sequestration, but they may also stimulate emissions of the powerful greenhouse gas nitrous oxide (N2O). Although there are crop residue management measures to reduce N2O emissions, N2O reductions achieved at national scale with these measures have been seldom studied, and how farmers' willingness to accept the measures constrains their potential remains largely unknown. Using Denmark as a case study, we combined a survey (completed by 592 farmers) and national data to assess the practical potential and obstacles for the successful implementation of management strategies to reduce N2O emissions from crop residues. Crop residue removal (particularly from vegetables and cover crops) and nitrification inhibitors were identified as effective in reducing N2O emissions from a biophysical perspective. If all aboveground crop residues from vegetables and cover crops were removed, N2O emissions could be reduced by 0.181 Gg N2ON, corresponding to 11% of the total N2O emissions from crop residues nationally. However, a low percentage of farmers would be willing to remove crop residues from the field, especially for vegetables and cover crops (25%), in connection to the possible short- to medium-term reduction in C sequestration. Similarly, use of nitrification inhibitors would reduce emissions by 0.247 Gg N2ON, corresponding to 15% of the total residue N2O emissions, and only 37% of all farmers would accept their use. Our results highlight that farmer' preferences for the adoption of measures can constrain the use of the few available effective mitigation options. Better knowledge dissemination and advisory services are crucial to address this challenge; farmers may be motivated to remove aboveground crop residues by highlighting the proportionally more important contribution of belowground residues to C sequestration, and that aboveground residues may have commercial value (biorefining, biogas, biofuel), although these options need further development.

Diagnostic considerations in a 16-year-old girl with multiple personalities.

This case report describes a 16-year-old patient, who presented with multiple personalities. A diagnosis of dissociative identity disorder (DID) was considered, but rejected, based on the patient's presenting psychopathology and a lack of confidence in the current scientific literature describing the diagnosis. DID is a rare diagnosis in Danish clinical practice and there is much dissent concerning its validity.

Comparing surgical strategies for end-stage anteromedial osteoarthritis : total versus unicompartmental knee arthroplasty.

AIMS: Treatment of end-stage anteromedial osteoarthritis (AMOA) of the knee is commonly approached using one of two surgical strategies: medial unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA). In this study we aim to investigate if there is any difference in outcome for patients undergoing UKA or TKA, when treated by high-volume surgeons, in high-volume centres, using two different clinical guidelines. The two strategies are 'UKA whenever possible' vs TKA for all patients with AMOA. METHODS: A total of 501 consecutive AMOA patients (301 UKA) operated on between 2013 to 2016 in two high-volume centres were included. Centre One employed clinical guidelines for the treatment of AMOA allowing either UKA or TKA, but encouraged UKA wherever possible. Centre Two used clinical guidelines that treated all patients with a TKA, regardless of wear pattern. TKA patients were included if they had isolated AMOA on preoperative radiographs. Data were collected from both centres' local databases. The primary outcome measure was change in Oxford Knee Score (OKS), and the proportion of patients achieving the patient-acceptable symptom state (PASS) at one-year follow-up. The data were 1:1 propensity score matched before regression models were used to investigate potential differences. RESULTS: The matched cohort included 400 patients (mean age 67 years (SD 9.55), 213 (53%) female, mean BMI 30.2 kg/m2, 337 (84%) American Society of Anesthesiologists grade ≤ 2). We found a mean adjusted difference in change score of 3.02 points (95% confidence interval (CI) 1.41 to 4.63; p < 0.001) and a significantly larger likeliness of achieving PASS (odds ratio 3.67 (95% CI 1.73 to 8.45); p = 0.001) both in favour of the UKA strategy. CONCLUSION: UKA and TKA are both good strategies for treating end-stage AMOA. However, when compared as a strategy, UKA achieved larger improvements in OKS, and were more likely to reach the PASS value at one-year follow-up. Cite this article: Bone Jt Open 2022;3(5):441-447.

Changes in key recruitment performance metrics from 2008-2019 in industry-sponsored phase III clinical trials registered at ClinicalTrials.gov.

BACKGROUND: Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. AIM: Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). METHODS: The publicly available AACT database containing data on all trials registered at ClinicalTrials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. RESULTS AND CONCLUSION: Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average recruitment period of 13 months (IQR 7-23) in 2008-2011 to 18 months (IQR 11-28) in 2016-2019 (p = 0.0068). Further, phase III clinical trials have increased the number of registered sites per clinical trial by more than 30% during the last 12 years from a median number 43 sites (IQR 17-84) in 2012-2015 to 64 sites (IQR 30-118) in 2016-2019 (p = 0.025), and concurrently, the number of participants enrolled in clinical research has decreased significantly from 2012-2015 and 2016-2019 (p = 0.046). We believe that these findings indicate that recruitment for phase III clinical trials is less effective today compared to 12 years ago.