Associations of dexamethasone's effect on morphine consumption after total knee arthroplasty-Subgroup analyses.

The DEXamethasone twice for pain treatment after Total Knee Arthroplasty (DEX-2-TKA) trial showed that adding one and two doses of 24 mg intravenous dexamethasone to paracetamol, ibuprofen and local infiltration analgesia, reduced morphine consumption (primary outcome) within 48 h after TKA. We aimed to explore the differences in the effect of dexamethasone on morphine consumption in different subgroups. Quantile regression adjusted for site was used to test for significant interaction between the predefined dichotomised subgroups and treatment group. The subgroups were defined based on baseline data: sex (male/female), age (≤65 years/>65 years), American Society of Anaesthesiologists (ASA)-score (ASA I + II/III), visual analogue score of preoperative pain at rest (≤30 mm/>30 mm), pain during mobilisation (≤30 mm/>30 mm), type of anaesthesia (spinal anaesthesia/general anaesthesia and spinal converted to general anaesthesia), and prior daily use of analgesics (either paracetamol and/or NSAID/neither). These analyses were supplemented with post hoc multivariate linear regression analyses. Test of interaction comparing sex in the pairwise comparison between DX2 (dexamethasone [24 mg] + dexamethasone [24 mg]) versus placebo (p = .02), showed a larger effect of dexamethasone on morphine consumption in male patients compared to females. Test of interaction comparing age in the pairwise comparison between DX1 (dexamethasone [24 mg] + placebo) versus placebo (p = .04), showed a larger effect of dexamethasone on morphine consumption in younger patients (≤65 years) compared to older. All remaining subgroup analyses showed no evidence of a difference. The supplemental multivariate analyses did not support any significant interaction for sex (p = .256) or age (p = .730) but supported a significant interaction with the type of anaesthesia (p < .001). Our results from the quantile regression analyses indicate that the male sex and younger age (≤65 years) may be associated with a larger analgesic effect of dexamethasone than the effects in other types of patients. However, this is not supported by post-hoc multivariate linear regression analyses. The two types of analyses both supported a possible interaction with the type of anaesthesia.

Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial.

OBJECTIVES: The DEX-2-TKA trial demonstrated that one and two doses of 24 mg intravenous dexamethasone reduced opioid consumption and pain after total knee arthroplasty (TKA). We aimed to investigate the prolonged effects of dexamethasone after the 48-h intervention period. DESIGN: This was a prospective, pre-planned questionnaire follow-up on postoperative days 3-7 of patients in the DEX-2-TKA trial that randomly received: DX1 (dexamethasone 24 mg + placebo), DX2 (dexamethasone 24 mg + dexamethasone 24 mg), and placebo (placebo + placebo) perioperatively and 24 h later. SETTING: A multicenter trial performed at five Danish hospitals. PARTICIPANTS: We analyzed 434 of 485 adult participants enrolled in the DEX-2-TKA trial. OUTCOME MEASURES: Primary outcome was difference between groups in average of all numerical rating scale (NRS) pain scores reported in the morning, at bedtime, and the daily average pain on postoperative days 3-7. Secondary outcomes were sleep quality and patient satisfaction. RESULTS: The median (interquartile range) pain intensity levels for postoperative days 3-7 were: DX2 3.2 (2.1-4.3); DX1 3.3 (2.3-4.1); and placebo 3.3 (2.5-4.7). Hodges-Lehmann median differences between groups were: 0 (95% confidence interval - 0.54 to 0.2), P = 0.38 between DX1 and placebo; 0.1 (-0.47 to 0.33), p = .87 between DX1 and DX2; and 0.1 (-0.6 to 0.13), p = .20 between DX2 and placebo. We found no relevant differences between groups on sleep quality on postoperative days 3-7 nor for patient satisfaction with the analgesic treatment. CONCLUSIONS: We found that neither one nor two doses of 24 mg intravenous dexamethasone demonstrated prolonged effects on overall pain or sleep quality on postoperative days 3-7 after total knee arthroplasty. We also found that dexamethasone had no effect on patient satisfaction. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT03506789 (main result trial).

Transitivity, coherence, and reliability of network meta-analyses comparing proximal humerus fracture treatments: a meta-epidemiological study.

BACKGROUND: Network meta-analyses can be valuable for decision-makers in guiding clinical practice. However, for network meta-analysis results to be reliable, the assumptions of both transitivity and coherence must be met, and the methodology should adhere to current best practices. We aimed to assess whether network meta-analyses of randomized controlled trials (RCTs) comparing interventions for proximal humerus fractures provide reliable estimates of intervention effects. METHODS: We searched PubMed, EMBASE, The Cochrane Library, and Web of Science for network meta-analyses comparing interventions for proximal humerus fractures. We critically assessed the methodology regarding the development of a protocol, search strategy, trial inclusion, outcome extraction, and the methods used to conduct the network meta-analyses. We assessed the transitivity and coherence of the network graphs for the Constant score (CS), Disabilities of the Arm, Shoulder, and Hand score (DASH), and additional surgery. Transitivity was assessed by comparing probable effect modifiers (age, gender, fracture morphology, and comorbidities) across intervention comparisons. Coherence was assessed using Separating Indirect from Direct Evidence (SIDE) (Separating Indirect from Direct Evidence) and the design-by-treatment interaction test. We used CINeMA (Confidence in Network Meta-analyses) to assess the confidence in the results. RESULTS: None of the three included network meta-analyses had a publicly available protocol or data-analysis plan, and they all had methodological flaws that could threaten the validity of their results. Although we did not detect incoherence for most comparisons, the transitivity assumption was violated for CS, DASH, and additional surgery in all three network meta-analyses. Additionally, the confidence in the results was 'very low' primarily due to within-study bias, reporting bias, intransitivity, imprecision, and heterogeneity. CONCLUSIONS: Current network meta-analyses of RCTs comparing interventions for proximal humerus fractures do not provide reliable estimates of intervention effects. We advise caution in using these network meta-analyses to guide clinical practice. To improve the utility of network meta-analyses to guide clinical practice, journal editors should require that network meta-analyses are done according to a predefined analysis plan in a publicly available protocol and that both coherence and transitivity have been adequately assessed and reported.

Patients' behaviour after referral to a wound care clinic for diabetic foot ulcer care: a grounded theory study.

OBJECTIVE: The aim of this study was to construct a grounded theory regarding patients' activity behaviour over time after referral to an outpatient clinic for diabetic foot ulcer (DFU) care. METHOD: A constructivist grounded theory approach was used. Data from observations of and interviews with participants were collected and analysed using the constant comparative method. Based on this, the grounded theory 'Just a bump in the road' was constructed. RESULTS: The cohort included five participants who considered their ulcers as 'Just a bump in the road' in their lives, and four subcategories were embedded in this core category: 'Restricting my freedom'; 'Trusting or doubting the system'; 'Feeling no pain or illness'; and 'Receiving insufficient information'. Together, these categories describe the participants' behaviour and underlying concerns related to daily activities after referral to an outpatient clinic for the care of their DFU. CONCLUSION: The grounded theory 'Just a bump in the road' describes how participants with a DFU viewed their condition as merely a passing phase that would end with them regaining what they considered a normal life. Integrating these results into clinical practice could lead to improved care and a focus shift among health professionals from viewing patients as being defined by their wounds to seeing them as people who live with a wound.

Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial.

BACKGROUND: The RECIPE trial systematically investigates the effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimise risk of bias and to prevent data-driven analysis, we present this detailed statistical analysis plan. METHODS: The RECIPE trial is a randomised, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 h postoperatively. Primary outcome is total opioid consumption 0-24 h after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges-Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind. DISCUSSION: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.

Unchanged incidence but change in treatment trends from 1996 to 2018: 23,718 humeral shaft fractures from the Danish National Patient Registry.

BACKGROUND AND PURPOSE: Humeral shaft fractures (HSF) can be treated surgically or non-surgically. National trends and distributions are sparsely reported. We present the temporal trends in epidemiology of adult HSF in Denmark, with the primary aim of reporting HSF incidences, and the secondary aim of reporting on the primary treatment management. PATIENTS AND METHODS: The diagnosis (International Classification of Diseases Version 10 [ICD-10]: S42.3) and surgical procedure codes for HSF were obtained from the Danish National Patient Registry (DNPR) covering 1996-2018. The diagnosis code for HSF is validated in the DNPR with a positive predictive value of 89%. Patients aged 18 years and above were included. Surgical treatment was defined as a diagnosis of HSF combined with a surgical procedure within 3 weeks of injury. Cases without relevant registered procedures within 3 weeks were defined as nonsurgical treatment cases. RESULTS: 23,718 HSF (62% female) were identified in the DNPR. The overall mean incidence was 25/100,000/year and was stable over 23 years. The population above 50 years accounted for 78% of all HSF. Non-surgical treatment accounted for 87% of treatments and was stable during the study period. Temporal changes were observed regarding surgical procedures; intramedullary nailing decreased from 57% to 26% and plate osteosynthesis increased from 12% to 69%. CONCLUSION: The overall incidence for HSF remained stable from 1996 to 2018. Most cases were females aged 50 years and above. The preferred primary treatment for HSF was non-surgical for all ages. Plate osteosynthesis became more popular than intramedullary nailing over the study period.

Interventions for treating proximal humeral fractures in adults.

BACKGROUND: Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015. OBJECTIVES: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.  DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison. MAIN RESULTS: We included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below. Early (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures Five trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment. Surgical versus non-surgical treatment Ten trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants). Open reduction and internal fixation with a locking plate versus a locking intramedullary nail Four trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants). Reverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty There is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence). AUTHORS' CONCLUSIONS: There is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures. There is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.

Epidemiology and trends in management of acute proximal humeral fractures in adults: an observational study of 137,436 cases from the Danish National Patient Register, 1996-2018.

BACKGROUND AND PURPOSE: Proximal humeral fractures (PHF) can be managed surgically or non-surgically. Locking plates have been the preferred head-preserving surgical technique while hemiarthroplasty (HA) or reverse shoulder arthroplasty (RSA) have been used in joint replacement surgery. We describe the epidemiology and trends in management of acute PHF in Denmark with a focus on (i) changes in the incidence of PHF; (ii) changes in the proportion of surgical cases; and (iii) changes in preferred surgical techniques. PATIENTS AND METHODS: Data on diagnoses and interventions was retrieved from the Danish National Patient Register. Patients aged 18 years and above were included. Surgical treatment was defined as the diagnosis of PHF combined with a predefined surgical procedure code within 3 weeks of injury. Data on plate osteosynthesis, HA, RSA, and "other techniques" was retrieved. Non-surgical treatment was defined as no relevant surgical procedure code within 3 weeks. RESULTS: We identified 137,436 PHF (72% women) in the Danish National Patient Register. The overall mean incidence was 138/100,000/year (500 for women 60 years or above). Non-surgical treatment accounted for 119,966 (87%). The 17,470 surgical procedures included 42% locking plates, 34% arthroplasties, and 25% other techniques. The rate of surgery declined from 17% in 2013 to 11% in 2018. INTERPRETATION: The overall incidence of PHF remained stable between 1996 and 2018 but the absolute number increased. The approach to PHF remains predominantly non-surgical. The number of surgeries in Denmark have decreased since 2013, especially for locking plates and HA, while RSA is increasingly used.

Peripheral nerve block anaesthesia and postoperative pain in acute ankle fracture surgery: the AnAnkle randomised trial.

BACKGROUND: Peripheral nerve blocks (PNBs) are increasingly popular in acute ankle fracture surgery but rebound pain may outweigh the benefits. The AnAnkle Trial was designed to assess the postoperative pain profile of PNB anaesthesia compared with spinal anaesthesia (SA). METHODS: The AnAnkle Trial was a randomised, two-centre, blinded outcome analysis trial. Eligible adults booked for primary ankle fracture surgery were randomised to PNB or SA. The PNBs were ultrasound-guided popliteal sciatic and saphenous blocks with ropivacaine and SAs were with hyperbaric bupivacaine. Postoperatively, all subjects received paracetamol, ibuprofen, and patient-controlled i.v. morphine for pain. The primary endpoint was 27 h Pain Intensity and Opioid Consumption (PIOC) score. Secondary endpoints included longitudinal pain scores and morphine consumption separately, and questionnaires on quality of recovery. RESULTS: This study enrolled 150 subjects, and the PNB success rate was >94%. PIOC was lower with PNB anaesthesia (median, -26.5% vs +54.3%; P<0.001) and the probability of a better PIOC score with PNB than with SA was 74.8% (95% confidence interval, 67.0-82.6). Pain scores and morphine consumption analysed separately also yielded a clear benefit with PNB, despite substantial rebound pain when PNBs subsided. Quality of recovery scores were similar between groups, but 99% having PNB vs 90% having SA would choose the same anaesthesia form again (P=0.03). CONCLUSIONS: PNB anaesthesia was efficient and provided a superior postoperative pain profile compared with SA for acute ankle fracture surgery, despite potentially intense rebound pain after PNB. CLINICAL TRIAL REGISTRATION: Clinicaltrialsregister.eu, EudraCT number: 2015-001108-76.

A medical history of arterial thrombosis is a strong predictor of post-operative myocardial infarction and stroke in patients with hip fractures-a nationwide cohort study.

INTRODUCTION: Hip fractures lead to a substantial burden of disease and mortality among the elderly. Myocardial infarction (MI) and stroke are serious and overlooked complications, and their impact on mortality and morbidity may be underestimated. We investigated; 90-day absolute risk of stroke and MI following hip fracture surgery, and ii) anamnestic risk factors associated with elevated risk of postoperative MI and stroke. METHODS: All Danish patients aged ≥60 undergoing first time hip fracture surgery in 2000-2017 were identified. Outcomes were MI or stroke 90 days after surgery. We performed gender-stratified cumulative incidence functions and multivariate Cox regression models adjusted for age and comorbidities. RESULTS: 124,660 patients were included. Incidence of MI was 2.2% and 1.3%, and incidence of stroke was 3.5% and 2.5%, in men and women, respectively. The most important risk factor for MI and stroke was a previous event. Hazard ratio (HR) of MI associated with previous MI was 2.43 (95% Confidence Interval (CI) 2.02-2.92) in men and 2.65 (95% CI 2.23-3.16) in women, while the HR of stroke associated with previous stroke was 4.17 (95% CI 3.73-4.67) and 3.73 (95% CI 3.43-4.08), respectively. Other risk factors of MI were; sex, age, and a history of heart failure, hypertension, peripheral artery disease or diabetes. For postoperative stroke; sex age, and atrial fibrillation were important risk factors. CONCLUSION: MI and stroke after hip fractures are overlooked and serious complications. Persons with elevated risk can be identified at admission, based on their medical history.

Supervised Training Compared With No Training or Self-training in Patients With Subacromial Pain Syndrome: A Systematic Review and Meta-analysis.

OBJECTIVE: To study the effects of supervised training in adults with subacromial pain syndrome. DATA SOURCES: Embase, MEDLINE, Cochrane Library, Cumulative Index to Nursing and Allied Health, and Physiotherapy Evidence Database were searched from inception to March 2020. STUDY SELECTION: Independent reviewers selected randomized controlled trials comparing supervised training with (1) no training or (2) self-training in adults with subacromial pain syndrome lasting for at least 1 month. Critical outcomes were shoulder pain, function, and patient-perceived effect. Important outcomes included other potential benefits and adverse events at 3-month follow-up. DATA EXTRACTION: Two independent reviewers extracted data for the meta-analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool 1, and certainty of evidence was evaluated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE). DATA SYNTHESIS: Ten studies (n=597, 43% female) were included. Supervised training resulted in larger improvements than no training on pain (at rest: n=286; mean difference [MD], 1.68; 95% confidence interval [CI], 0.31-3.06 on 0-10 scale; during movement: n=353; MD, 1.84; 95% CI,0.91-2.76), function (n=396; standardized MD, 0.30; 95% CI, 0.07-0.52), and patient-perceived effect (n=118; risk ratio, 1.43; 95% CI, 0.87-2.34). Supervised training had potential benefits regarding quality of life, return to work, dropout, and training adherence, albeit more patients reported mild, transient pain after training. Supervised training and self-training showed equal improvements on pain (n=44) and function (n=76), with no data describing patient-perceived effect. Certainty of evidence was low for critical outcomes and low-moderate for other outcomes. CONCLUSIONS: Supervised training might be superior to no training and equally effective as self-training on critical and important outcomes. Based on low-moderate certainty of evidence, these findings support a weak recommendation for supervised training in adults with subacromial pain syndrome.

Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process.

BACKGROUND: Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. METHODS: A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. RESULTS: The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. CONCLUSIONS: International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. TRIAL REGISTRATION: Not applicable.

Sex differences in incidence rate, and temporal changes in surgical management and adverse events after hip fracture surgery in Denmark 1997-2017: a register-based study of 153,058 hip fracture patients.

Background and purpose - Extensive research and national multidisciplinary programs have striven to introduce uniform standards of treatment and mitigate mortality and adverse events after hip fracture surgery over the past decades. A large-scale overview of temporal developments in hip fracture surgery and care is warranted.Patients and methods - We studied Danish patients aged ≥ 60 years, sustaining their first ever hip fracture between 1997 and 2017. Patients were identified from the Danish National Patient Registry (DNPR). Incidence rates of first hip fracture were calculated per 1,000 patient-years and stratified by age group and sex. Information on pre-injury living settings, comorbidities, and medications were obtained from national administrative registers. Type of fracture and treatment choice were recorded, and patients were followed for 1 year to observe mortality, readmission, and surgical complications.Results - Data from 153,058 patients was analyzed. Incidence rate decreased in both sexes, but only led to a reduction in the annual number of hip fractures in the female population. Choice of surgery shifted away from sliding hip screws and parallel implants (SHS-PI), towards intramedullary nailing and hemi-/arthroplasties for trochanteric and femoral neck fractures, respectively. Pre-injury diagnosed morbidity and 1-year readmissions increased contrary to mortality. Median age remained stable around 83 (IQR 77-88) for women and 80 (IQR 73-86) for men.Interpretation - Over the past 2 decades important aspects of hip fracture management have improved. However, sex differences were observed, and men remain more vulnerable than women in terms of morbidity, mortality, and incidence rate.

DEX-2-TKA - DEXamethasone twice for pain treatment after Total Knee Arthroplasty: Detailed statistical analysis plan for a randomized, blinded, three-group multicentre clinical trial.

BACKGROUND: Optimization of post-operative pain treatment is of upmost importance. Multimodal analgesia is the main post-operative pain treatment principle, but the evidence on optimal analgesic combinations is unclear. With the "DEXamethasone twice for pain treatment after TKA" trial, we aim to investigate the role of one or two doses of glucocorticoid for post-operative pain treatment after total knee arthroplasty. To ensure transparency and minimization of bias, we present this article with a detailed statistical analysis plan, to be published before the last participant is enrolled. METHODS: "DEXamethasone twice for pain treatment after TKA" (DEX-2-TKA) is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three intervention groups: single dose of iv dexamethasone 24 mg, two consecutive doses of iv dexamethasone 24 mg or matching iv placebo. All three intervention groups will receive paracetamol, NSAID (ibuprofen) and local infiltration analgesia. Participants, treatment providers, outcome assessors, data managers, statisticians and conclusion drawers will be blinded to the allocated intervention. The primary outcome is total opioid consumption (iv morphine milligram equivalents) 0-48 hours post-operatively. Secondary outcomes are (1) visual analogue scale pain levels: (a) during active 45 degrees flexion of the knee at 24 and 48 hours post-operatively, (b) at rest at 24 and 48 hours post-operatively, and (c) during 0-24 hours (highest score) and 24-48 hours post-operatively (highest score); and (2) the proportion of participants with one or more adverse events within 48 hours post-operatively. DISCUSSION: The DEX-2-TKA trial will provide high quality data regarding benefits and harms of adding one or two high-doses of dexamethasone to a multimodal analgesic regimen. TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019).

DEX-2-TKA-DEXamethasone twice for pain treatment after Total Knee Arthroplasty: A protocol for a randomized, blinded, three-group multicentre clinical trial.

BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists. AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption. METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively. INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent. EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90% for the three possible pairwise comparisons. DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020. TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.

What Factors are Associated with Revision or Worse Patient-reported Outcome after Reverse Shoulder Arthroplasty for Cuff-tear Arthropathy? A Study from the Danish Shoulder Arthroplasty Registry.

BACKGROUND: Reverse shoulder arthroplasty has been proven to improve function in shoulders with cuff-tear arthropathy, but existing studies are primarily single-center studies with a small number of patients, which limits their ability to identify patients who have an increased risk of revision or a worse functional outcome. QUESTIONS/PURPOSES: (1) What is the estimated 10-year cumulative revision rate after reverse shoulder arthroplasty for cuff-tear arthropathy, and what factors are associated with the risk of revision? (2) What is the patient-reported outcome 1 year after surgery, and what factors are associated with a worse patient-reported outcome? METHODS: We included all patients treated with reverse shoulder arthroplasty for cuff-tear arthropathy reported in the Danish Shoulder Arthroplasty Registry from 2006 to 2015. During the study period, the completeness of reporting was 93% for both primary and revision arthroplasties. Estimated revision rates were illustrated using the Kaplan-Meier method, and hazard ratios were calculated using a Cox regression model. Patient-reported outcome was measured with a postal survey at 12 months (range 10-14 months) postoperatively using the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. The WOOS is a patient-administered questionnaire that measures the quality of life of patients with glenohumeral osteoarthritis. A visual analog scale that ranges from 0 to 100 is used for each question. There are 19 questions, giving a total score ranging from 0 to 1900, with 1900 being the worst. For simplicity of presentation, raw scores were converted to a percentage of the maximum score, with 100 being the best. There is no defined minimal clinically important difference of the WOOS, but the Danish Shoulder arthroplasty registry has for many years regarded an arbitrary difference of 10 or above as being clinically relevant. The rate of response to the WOOS was 71%. RESULTS: The estimated 10-year cumulative revision rate was 8.5% (95% confidence interval, 5.7%-11.3%) with differences between the arthroplasty model (21.0%; 95% CI, 11.8% to 30.8% for the Delta Mark III and 5.5%; 95% CI, 3.7% to 7.3% for the Delta Xtend) and gender (6.0%; 95% CI, 3.0% to 9.0% for women and 13.1%; 95% CI, 7.1% to 19.1% for men). After controlling for potential confounding variables including gender, previous surgery, arthroplasty model, and period of surgery, the risk of revision was higher with the Delta Mark III than with the Delta Xtend (hazard ratio 2.7; 95% CI, 1.3 to 5.4; p < 0.01) and higher in men than in women (hazard ratio 2.7; 95% CI, 1.6 to 4.7; p < 0.01). Thirty-three percent (19 of 57) of the revision arthroplasties were performed for dislocation and 32% (18 of 57) were to treat periprosthetic joint infection. After controlling for confounding variables, only previous surgery was associated with a worse WOOS score (mean difference -10.6; 95% CI, -15.2 to -5.9; p < 0.01); there were no associations between a worse score and gender, arthroplasty model, age group, or period of surgery. CONCLUSIONS: The results from the present study can be used to inform patients about their individual risk of revision or a disappointing functional outcome. The study also demonstrates the need for proper patient selection and attention to technical details to reduce the risk of revision, especially for men. Our follow-up time was, however, short, with only an estimate of the 10-year revision rate. Future studies with a long-term follow-up duration are needed to confirm our results. LEVEL OF EVIDENCE: Level III, therapeutic study.

Assessment of diabetic foot ulcers based on pictorial material: an interobserver study.

OBJECTIVE: The frequent change in clinicians, and the emerging use of photographic documentation in wound management, could require a more diverse treatment of patients due to poor interobserver agreement. The aim of this study was to assess the interobserver agreement of a commonly used classification system for diabetic foot ulcers (DFUs), the Meggitt-Wagner classification, and to compare the agreement on classification with the agreement in treatment recommendations. METHOD: An interobserver study was conducted based on a questionnaire linked to 30 photographs of DFUs. Different groups of observers were tested to investigate whether there was a difference between professions or level of education: experienced orthopaedic wound care doctors (n=7); nurses specialised in wound care (n=8) and untrained nurses assigned to a diabetic wound care training course (n=23). Krippendorff's alpha was used to calculate interobserver agreement, and an agreement of >0.67 was defined as substantial. RESULTS: The Krippendorff's alpha value for interobserver agreement on the Meggitt-Wagner classification was 0.52 for the doctors group, 0.67 for the specialised nurses and 0.61 for the untrained nurses. The corresponding values regarding agreement on recommendation of surgical revision of the wound were 0.35, 0.22 and 0.15, respectively. The choice of dressing type or antibiotic treatment had even lower interobserver agreement. CONCLUSIONS: The interobserver agreement on the Meggitt-Wagner classification was substantial in the specialised nurse group, but the evaluation and treatment of DFUs should not be exclusively based on pictorial materials.

Low arthroplasty survival after treatment for proximal humerus fracture sequelae: 3,245 shoulder replacements from the Nordic Arthroplasty Register Association.

Background and purpose - Proximal humerus fractures (PHF) may result in sequelae indicating arthroplasty. We report cumulative survival rates and reasons for revision after arthroplasty for proximal humerus fracture sequelae (PHFS).Patients and methods - Data were derived from the Nordic Arthroplasty Register Association. The Kaplan-Meier method was used to illustrate survival rates. A scaled Schoenfeld residual plot was used to report the risk of revision for men relative to women in patients who were treated with reverse shoulder arthroplasty (RSA). Revision was defined as removal or exchange of any component or the addition of a glenoid component.Results - 30,190 primary arthroplasties were reported from 2004 to 2016, of which 3,245 were for PHFS. The estimated 1-, 5-, and 10-year cumulative survival rates (95% CI) were 96% (95-97), 90% (89-92), and 86% (83-88) for stemmed hemiarthroplasty and 94% (92-95), 89% (87-91), and 86% (82-90) for RSA with a median time to revision of 18 months (IQR 9-44) and 3 months (IQR 0-17). The risk of revision for men relative to women in patients who were treated with RSA was 3.2 (1.9-5.1) 0-1 year after surgery and 1.9 (0.9-4.1) 1-8 years after surgery. The estimated 1-, 5-, and 10-year cumulative survival rates (95% CI) were 94% (92-96), 88% (85-90), and 80% (75-86) for men and 95% (94-96), 86% (84-89), and 81% (77-84) for young patients.Interpretation - Shoulder arthroplasty for PHFS was associated with lower survival rates, compared with previously published results of shoulder arthroplasty for acute PHF. The low arthroplasty survival rates for men and young patients especially are worrying.

Rebound pain following peripheral nerve block anaesthesia in acute ankle fracture surgery: An exploratory pilot study.

BACKGROUND: Peripheral nerve blocks (PNB) are increasingly used for anaesthesia and postoperative pain control in acute orthopaedic limb surgery but rebound pain upon cessation of PNBs may challenge the benefits on the pain profile. We aimed to explore the pain profile following acute ankle fracture surgery under PNB anaesthesia and investigate if rebound pain could pose a clinical problem. METHODS: Exploratory, observational study of adults scheduled for acute primary internal fixation of an ankle fracture under ultrasound-guided popliteal sciatic and saphenous ropivacaine block anaesthesia. Postoperatively, patients regularly registered pain scores while receiving a fixed analgesics regimen and patient controlled morphine on-demand. We analysed morphine consumption and depicted the detailed pain profiles as graphs allowing for visual analysis of pain courses, including rebound pain. Secondly, we compared the area under the curve and peak pain between relevant age-subgroups. RESULTS: We included 21 patients aged 20-83. Depicted pain profiles reveal that PNB supplied effective and long lasting postoperative pain control, but cessation of the PNB led to intense rises in pain scores with six out of nine 20-60-year-olds reaching severe pain levels. The rebound was less pronounced in patients >60 years old, but nearly all reached moderate pain levels. Morphine consumption rates were high during the rebound. CONCLUSIONS: This study thoroughly analyses the post-PNB pain profile and suggests rebound pain is a clinically relevant and problematic issue with the potential to outweigh the PNB benefits, especially for younger patients. The conclusions are tentative, and a randomised study is pending.

Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions.

BACKGROUND: A majority of proximal humeral fractures can be managed without surgery. Recent randomized clinical trials and meta-analyses even question the benefit of surgical treatment for displaced 3-, and 4-part fractures. However, evidence-based treatment recommendations, balancing benefits and harms, presuppose a common reporting of complications and adverse events, which at the moment is largely missing. Therefore we systematically reviewed the use of terms and definitions of complications after nonsurgical management of proximal humeral fractures. METHODS: We searched PubMed, EMBASE, Cochrane Library, Scopus and WorldCat (2010-2017) and included articles and book chapters containing complication terms or definitions. Two reviewers independently extracted and grouped terms and definitions according to a predefined scheme. Terms and definitions concerning non-surgical management were tabulated, grouped and analyzed qualitatively. RESULTS: The initial search identified 1376 references from which 470 articles were selected for full-text retrieval. Data-extraction included first articles published in 2017, was then performed iteratively in batches of 20 articles, and terminated after retrieval of 91 articles when no additional definitions or terms was found. In addition, 12 book chapters were reviewed from an initial list of 100. No general definition of a complication was found. A total of 69 terms for complications after non-surgical management were identified from 19 articles. Sixty-seven terms regarded local events. The most commonly reported event terms regarded osteonecrosis, malunion, secondary displacement and rotator cuff problems. Seven individual terms were accompanied by some kind of definition. Most terms and definitions were based on radiographical assessments. CONCLUSIONS: We found no consensus in the use of terms and definitions of complications after nonsurgical management of proximal humeral fractures. Multiple terms, some synonymous, some partly synonymous, some distinct, were used. Few complication terms were explicitly defined. Development and validation of an internationally consensus-based core event set for complications after proximal humeral fractures managed non-surgically is needed.