Prospective Clinical Evaluation of the Singularity™ Air Laryngeal Mask in Adult Patients.

A laryngeal mask is one of the most widely used airway management devices. The SingularityTM Air is a second-generation laryngeal mask whose shaft angle can be adjusted after insertion. Since the device's performance has been assessed on mannequins only, this study aimed to evaluate SingularityTM Air's effectiveness in the clinical setting. The prospective single-center cohort study included 100 adults undergoing elective surgery under general anesthesia and suitable for airway securing with a laryngeal mask. The primary endpoint was the oropharyngeal leak pressure, and the secondary endpoints were the ease of insertion and the patient's comfort. Laryngeal mask insertion was successful in 97%, and mechanical ventilation was possible in 96% of patients. After insertion, the median (IQR) oropharyngeal leak pressure was 25 (18-25) cm H2O, which remained stable at 25 (25-25) cm H2O after 20 min. The median (IQR) time for successful manual bag ventilation was 42 (34-50) seconds. Nineteen patients complained of side effects (e.g., sore throat, difficulty swallowing), but none persisted. The SingularityTM Air performed well in a clinical setting, and its oropharyngeal leak pressure was comparable to that of other masks reported in the literature. The time for successful manual ventilation was slightly longer, and patients reported more temporary side effects.

Is malunion of the greater tuberosity after reverse shoulder arthroplasty in patients with complex proximal humerus fracture associated with worse clinical outcomes? A prospective cohort study.

PURPOSE: To assess patient outcomes following reverse shoulder arthroplasty in patients with complex proximal humerus fracture and the clinical implications of greater tuberosity malunions. METHODS: This prospective study included 56 patients who underwent RSA (DELTA XTEND™, DePuy Synthes, Warsaw, IN, USA) to treat proximal humerus fractures. We used a standardized suture technique to reattach the tuberosities. Demographic, comorbidity, and radiological parameters were collected. Assessments at 2-year follow-up (n = 49) are given as follows: range of motion (ROM), pain level, Constant Murley scores (CS), subjective shoulder value (SSV), and tuberosity healing. RESULTS: Anatomic tuberosity healing was achieved in 31 (55%) patients (group 1), 14 (25%) had a malunion (group 2), and complete migration occurred in 11 (20%) (group 3). No statistically significant differences between groups 1 and 2 were detected: CS (p = 0.53), SSV (p = 0.07), ROM (forward flexion (FF) p = 0.19, internal rotation (IR) p = 0.34, and external rotation (ER) p = 0.76). Group 3 had poorer outcomes (median [IQR]) than group 1: CS (59 [50-71]) vs. 72 [65-78]), FF (120 [100-150]) vs. 150 [125-160] and ER (- 20 [- 20 to 10] vs. 30 [20-45], respectively. Three complications (group 1) occurred: one-stage revision after low-grade infection, haematoma due to early rivaroxaban intake, and open reduction and internal fixation for acromion insufficiency fracture. No patients showed signs of stem or glenoid loosening after 2 years. CONCLUSION: Cases with complete superior migration experienced poorer clinical outcomes than those with anatomic healing. Despite a relatively high malunion rate, the outcomes were not significantly worse in these patients compared to anatomically healed GT cases.

Spinal cord injury and prescribed opioids for pain: a scoping review.

OBJECTIVE: Spinal cord injury (SCI) is a life-altering neurological condition affecting physical and psycho-social functioning and associated high rates of pain. Thus, individuals with SCI may be more likely to be exposed to prescription opioids. A scoping review was conducted to synthesize published research findings on post-acute SCI and prescription opioid use for pain, identify literature gaps, and propose recommendations for future research. METHODS: We searched 6 electronic bibliographic databases (PubMed [MEDLINE], Ovid [MEDLINE], EMBASE, Cochrane Library, CINAHL, PsychNET) for articles published from 2014 through 2021. Terms for "spinal cord injury" and "prescription opioid use" were used. Included articles were in English and peer reviewed. Data were extracted using an electronic database by 2 independent reviewers. Opioid use risk factors for chronic SCI were identified and a gap analysis was performed. RESULTS: Of the 16 articles included in the scoping review, a majority were conducted in the United States (n = 9). Most articles lacked information on income (87.5%), ethnicity (87.5%), and race (75%). Prescription opioid use ranged from 35% to 64% in articles reporting this information (n = 7 articles, n = 3675 participants). Identified risk factors for opioid use included middle age, lower income, osteoarthritis diagnosis, prior opioid use, and lower-level spinal injury. Limited reporting of diversity in study populations, absence of risk of polypharmacy, and limited high quality methodology were identified gaps. CONCLUSIONS: Future research should report data on prescription opioid use in SCI populations, with additional demographics such as race, ethnicity, and income, given their importance to risk outcomes.

Complications following arthroscopic-assisted coracoclavicular stabilization in patients with unstable lateral clavicle fractures.

PURPOSE: Lateral clavicle fractures are unstable and prone to nonunions, which is why they are often treated surgically rather than conservatively. Despite the variety of surgical techniques found in the literature, the best method for treating this rare fracture type has not yet been determined. Our case series aimed to describe a coracoclavicular (CC) reconstruction technique and to assess complications and patient outcomes 1 year postoperatively. METHODS: Nineteen patients who underwent surgery for an unstable lateral clavicle fracture (IIB, IIC, IID) with a suture button device (Dog Bone, Arthrex, Inc., Naples, FL, USA) were available for clinical and radiological follow-up. The assessments included the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) score, the Constant Score (CS), the Subjective Shoulder Value (SSV), as well as the ipsilateral and contralateral coracoclavicular distance. RESULTS: The median age was 50 years (IQR 28-59), 13 (68.4%) were male and the delay to surgery was 5 days (IQR 2-9). The median clinical scores were 100 (ASES), 91 (CS), and 95 (SSV). The CC distance improved postoperatively (p = 0.003). However, nonunion occurred in 3 (15.8%) patients, 5 (26.3%) had other complications, and 5 (26.3%) needed revision surgery (4 plate removals and 1 pseudoarthrosis). The overall complication rate was 36.8%. CONCLUSION: Restoring the CC ligaments alone could not reliably achieve fracture stability, with more than one-third of cases in this series experiencing major complications. Given the high revision and nonunion rates, we do not recommend this type of surgical technique.

Compatibility of left-sided double-lumen endobronchial tubes with tracheal and bronchial dimensions: a retrospective comparative study.

BACKGROUND: Double-lumen endobronchial tubes (DLT) continue to be the most widely used method for obtaining lung isolation during anesthesia. We compared recommendations for DLT size selection with radiologically assessed lower airway dimensions gathered from a large patient population. METHODS: For this retrospective comparative study, we assessed computed tomography (CT) scans of 150 adults with no known airway pathologies. Using these scans, we measured the diameter and length of the trachea and the diameter of the mainstem bronchi. These airway dimensions were then compared to the dimensions of left-sided DLTs of three different manufacturers. Size selection was based on one standard textbook's recommendations. RESULTS: We found the recommended DLT sizes were occasionally too small but more often too large, particularly in the endobronchial airway. With the DLT Vivasight-DL®, mismatching occurred in 28.7% (43/150) of the patients at the distal mainstem bronchus and 8% (12/150) at the tracheal level. This mismatching happened most often in females (left distal mainstem bronchus 34/68, 50%; trachea 9/68, 13.2%). Conversely, the DLT was more often too small for male patients in both the left main bronchus (SHER-I-BRONCH®: 8/82, 9.8%) and the trachea (SHER-I-BRONCH®: 2/82, 2.4%). The endobronchial tube portion was more often too long in females (Vivasight® DLT: 11/68, 16%) than males (9/82, 11%). CONCLUSIONS: A considerable proportion of the recommended DLT sizes from all three manufacturers was incompatible with individual patient's lower airway dimensions.

A retrospective comparison of clinical and radiological outcomes using palmar or dorsal plating to treat complex intraarticular distal radius fractures (AO 2R3 C3).

INTRODUCTION: Complex intraarticular distal radius fractures are common, and treatment with open reduction and internal fixation (ORIF) can be done through either the palmar or dorsal approach. There is scant evidence, however, indicating which approach is more suitable. We compared clinical and radiological outcomes of patients with AO 2R3 C3 fractures surgically treated with one of these approaches. MATERIALS AND METHODS: From January 2015 to November 2018, 72 surgically treated patients with AO 2R3 C3 fractures were radiologically (12 months) and clinically (mean 26 months) evaluated. Forty-one patients underwent ORIF using the palmar approach (Group 1), and the dorsal approach was used in 31 patients (Group 2). Radiological parameters were measured using the AO scoring system immediately following surgery and 12 months later. Clinical assessments included the range of motion, PRWE and DASH scores. RESULTS: At the immediate postoperative assessment, the median AO score was 5.5 (IQR 2-9.5, range 0-30.5) for Group 1 and 8 (IQR 5-15, range 0-27) for Group 2, and 12-month follow-up results were 4.5 (IQR 1.5-10, range 0-41) and 6.5 (IQR 5-11, range 0-29.5), respectively. Group 1 had more favorable results for the flexion, extension, radial abduction, PRWE and DASH parameters. The plate removal and reoperation rates were higher in Group 2. DISCUSSION: When treating complex intraarticular distal radius fractures, we found the palmar approach was more advantageous for this fracture pattern. Nevertheless, a dorsal approach may still be suitable for intraarticular comminuted distal radius fractures with dorsally displaced joint fragments.

Perioperative blood transfusions in hip and knee arthroplasty: a retrospective assessment of combined risk factors.

INTRODUCTION: Accurate identification of patients at risk of blood transfusion can reduce complications and improve institutional resource allocation. Probabilistic models are used to detect risk factors and formulate patient blood management strategies. Whether these predictors vary among institutions is unclear. We aimed to identify risk factors among our patients who underwent total hip (THA) or knee (TKA) arthroplasty, and combine these predictors to improve our model. MATERIALS AND METHODS: We retrospectively assessed risk factors among 531 adults who underwent elective THA or TKA from January 2016 to November 2018. Using relevant surgical and patient characteristics gathered from electronic medical records, we conducted univariable and multivariable analyses. For our logistic regression model, we measured the impact of independent variables (age, gender, operation type (THA or TKA) and preoperative hemoglobin concentration) on the need for a transfusion. RESULTS: Of the 531 patients, 321 had THA (uncemented) and 210 had TKA. For the selected period, our transfusion rate of 8.1% (10.6% THA and 4.3% TKA) was low. Univariable analyses showed that lower BMI (p < 0.001) was associated with receiving a transfusion. Important factors identified through logistic regression analyses were age (estimated effect of an interquartile range increase in age: OR 3.89 [CI 95% 1.96-7.69]), TKA (OR - 0.77 [CI 95% - 1.57-0.02]), and preoperative hemoglobin levels (estimated effect of interquartile range increase in hemoglobin: OR 0.47 [CI 95% 0.31-0.71]). Contrary to findings from previous reports, gender was not associated with transfusion. CONCLUSIONS: Previously published predictors such as advanced age, low preoperative hemoglobin, and procedure type (THA) were also identified in our analysis. However, gender was not a predictor, and BMI showed the potential to influence risk. We conclude that, when feasible, the determination of site-specific transfusion rates and combined risk factors can assist practitioners to customize care according to the needs of their patient population. LEVEL OF EVIDENCE: Level 3, retrospective cohort study.

The Accuracy of Wrist Skin Temperature in Detecting Ovulation Compared to Basal Body Temperature: Prospective Comparative Diagnostic Accuracy Study.

BACKGROUND: As a daily point measurement, basal body temperature (BBT) might not be able to capture the temperature shift in the menstrual cycle because a single temperature measurement is present on the sliding scale of the circadian rhythm. Wrist skin temperature measured continuously during sleep has the potential to overcome this limitation. OBJECTIVE: This study compares the diagnostic accuracy of these two temperatures for detecting ovulation and to investigate the correlation and agreement between these two temperatures in describing thermal changes in menstrual cycles. METHODS: This prospective study included 193 cycles (170 ovulatory and 23 anovulatory) collected from 57 healthy women. Participants wore a wearable device (Ava Fertility Tracker bracelet 2.0) that continuously measured the wrist skin temperature during sleep. Daily BBT was measured orally and immediately upon waking up using a computerized fertility tracker with a digital thermometer (Lady-Comp). An at-home luteinizing hormone test was used as the reference standard for ovulation. The diagnostic accuracy of using at least one temperature shift detected by the two temperatures in detecting ovulation was evaluated. For ovulatory cycles, repeated measures correlation was used to examine the correlation between the two temperatures, and mixed effect models were used to determine the agreement between the two temperature curves at different menstrual phases. RESULTS: Wrist skin temperature was more sensitive than BBT (sensitivity 0.62 vs 0.23; P<.001) and had a higher true-positive rate (54.9% vs 20.2%) for detecting ovulation; however, it also had a higher false-positive rate (8.8% vs 3.6%), resulting in lower specificity (0.26 vs 0.70; P=.002). The probability that ovulation occurred when at least one temperature shift was detected was 86.2% for wrist skin temperature and 84.8% for BBT. Both temperatures had low negative predictive values (8.8% for wrist skin temperature and 10.9% for BBT). Significant positive correlation between the two temperatures was only found in the follicular phase (rmcorr correlation coefficient=0.294; P=.001). Both temperatures increased during the postovulatory phase with a greater increase in the wrist skin temperature (range of increase: 0.50 °C vs 0.20 °C). During the menstrual phase, the wrist skin temperature exhibited a greater and more rapid decrease (from 36.13 °C to 35.80 °C) than BBT (from 36.31 °C to 36.27 °C). During the preovulatory phase, there were minimal changes in both temperatures and small variations in the estimated daily difference between the two temperatures, indicating an agreement between the two curves. CONCLUSIONS: For women interested in maximizing the chances of pregnancy, wrist skin temperature continuously measured during sleep is more sensitive than BBT for detecting ovulation. The difference in the diagnostic accuracy of these methods was likely attributed to the greater temperature increase in the postovulatory phase and greater temperature decrease during the menstrual phase for the wrist skin temperatures.

Tuberosity union in patients with proximal humerus fractures treated with reverse shoulder arthroplasty: a technical note and exploratory analysis.

PURPOSE: The use of reverse shoulder arthroplasty (RSA) to treat complex humerus fractures is increasing, especially in older, osteoporotic patients. Refixation and tuberosity healing are needed to achieve an optimal range of motion (ROM), external rotation, active forward elevation, and patient satisfaction. Proper healing has been reported, however, in only 40-84% of cases. Our study's aim was to describe a simple, reproducible fixation technique designed to improve tuberosity healing. METHODS: We included 30 patients with acute proximal humerus fractures undergoing RSA (Global Unite Reverse Fracture, DePuy Synthes, Warsaw, IN, USA) with tuberosity reattachment. The humerus stem was cemented in 24 cases. A standardized suture technique with two fiber tapes was used to reattach tuberosities. Clinical and radiological parameters, which were collected one year post-operatively, included ROM, pain level, Constant scores, subjective shoulder value (SSV), and tuberosity healing. RESULTS: The mean age of the patients was 79.3 years (± 7; range 65-92), and the tuberosity healing rate was 90.0% (27 of 30). Two patients showed migration (one nonunion, one malunion), and another had complete resorption after an initial period of proper healing. Radiolucent lines around the humerus stem occurred in one case, and three patients had scapular notching. The mean SSV was 86% (± 11; range 60-100), the Constant score was 72 (± 10.3; range 48-92), the active forward flexion was 140° (± 14.3; range 115-165), and external rotation was 23° (± 16.5; range 0-50). CONCLUSIONS: This reattachment technique, which is simple and reproducible, achieved a higher tuberosity healing rate than previously published rates.

Non-invasive continuous blood pressure monitoring (ClearSight™ system) during shoulder surgery in the beach chair position: a prospective self-controlled study.

BACKGROUND: The beach chair position that is commonly used in shoulder surgery is associated with relative hypovolemia, which leads to a reduction in arterial blood pressure. The effects of patient positioning on the accuracy of non-invasive continuous blood pressure monitoring with the ClearSight™ system (CS-BP; Edwards Lifesciences, Irvine CA, USA) have not been studied extensively. Our research aim was to assess agreement levels between CS-BP measurements with traditional blood pressure monitoring techniques. METHODS: For this prospective self-controlled study, we included 20 consecutively treated adult patients undergoing elective shoulder surgery in the beach chair position. We performed Bland-Altman analyses to determine agreement levels between blood pressure values from CS-BP and standard non-invasive (NIBP) methods. Perioperative measurements were done in both the supine (as reference) and beach chair surgical positions. Additionally, we compared invasive blood pressure (IBP) measurements with both the non-invasive methods (CS-BP and NIBP) in a sub-group of patients (n = 10) who required arterial blood pressure monitoring. RESULTS: We analyzed 229 data points (116 supine, 113 beach chair) from the entire cohort; per patient measurements were based on surgical length (range 3-9 supine, 2-10 beach chair). The mean difference (±SD; 95% limits of agreement) in the mean arterial pressure (MAP) between CS-BP and NIBP was - 0.9 (±11.0; - 24.0-22.2) in the beach chair position and - 4.9 mmHg (±11.8; - 28.0-18.2) when supine. In the sub-group, the difference between CS-BP and IBP in the beach chair position was - 1.6 mmHg (±16.0; - 32.9-29.7) and - 2.8 mmHg (±15.3; - 32.8-27.1) in the supine position. Between NIBP and IBP, we detected a difference of 3.0 mmHg (±9.1; - 20.8-14.7) in the beach chair position, and 4.6 mmHg (±13.3; - 21.4-30.6) in the supine position. CONCLUSIONS: We found clinically acceptable mean differences in MAP measurements between the ClearSight™ and non-invasive oscillometric blood pressure systems when patients were in either the supine or beach chair position. For all comparisons of the monitoring systems and surgical positions, the standard deviations and limits of agreement were wide. TRIAL REGISTRATION: This study was prospectively registered at the German Clinical Trial Register (www.DRKS.de; DRKS00013773 ). Registered 26/01/2018.

An observational study comparing the performance of TOF-Cuff with TOF-Scan monitoring during anaesthetic induction in clinical routine.

INTRODUCTION: Neuromuscular monitoring by acceleromyography assesses the effects of non-depolarising neuromuscular blocking agents used during anaesthesia induction to optimise intubation conditions. A new type of neuromuscular monitor, TOF-Cuff, integrates electrode stimulation into a blood pressure monitoring cuff. Comparisons of this device with TOF-Scan, considered a clinical standard acceleromyography device, have not been published. MATERIAL AND METHODS: This prospective, observational study was approved by the Ethics Committee East Switzerland (BASEC-nr. 2016-02044), and patients' consent was obtained before inclusion. The study's aim was to compare TOF-Cuff with TOF-Scan by measuring the duration from the administration of a neuromuscular blocking agent to a train-of-four (TOF) ratio of 0%. After anaesthesia induction, atracurium was administered (0.5 mg kg-1) and TOF ratios were recorded every 15 seconds using the two devices simultaneously. Patients were grouped according to body mass index (< or ≥ 30 kg m-2). RESULTS: Twenty-five non-obese and twenty-five obese patients were included. In non-obese patients, bias was -3 s (± 21.2; limits of agreement -44.7 to 38.4; P = 0.702). In obese patients, bias was -20 s (± 35.0; limits of agreement -88.6 to 48.6; P = 0.0139). Large intra-individual differences of up to 60 seconds were detected even in non-obese patients. CONCLUSIONS: A significant systematic difference in the time to reach a TOF ratio of 0% was found when using the two devices in obese patients. In non-obese and obese patients, there were large intra-individual and clinically relevant differences. The two devices cannot be used interchangeably.

Polyaxial locking plate fixation in periprosthetic, peri-implant and distal shaft fractures of the femur : a comparison of open and less invasive surgical approaches.

Polyaxial locking plate fixation is a widely performed treatment for femoral shaft, periprosthetic, and peri-implant fractures in elderly patients. This study's purpose was to compare patient outcomes following the open technique (OT) and less invasive techniques (LIT). Data were gathered from 44 patients with 46 fractures treated with polyaxial locking plate between 2010-2015. Twenty fractures underwent the OT and 26 had a LIT. Long-term assessments for 83% of the fractures were done at a median of 23 months postoperatively. Bone healing rates were 82% in the OT and 100% in the LIT group (p=0.0688). The difference in the median duration of the surgery (OT 120 minutes, LIT 73 minutes) (p< 0.001) was the main statistically significant finding. Both surgical techniques resulted in similarly favourable outcomes. The LIT would be the preferred operating technique, especially when treating patients more susceptible to intra- and/or postoperative morbidity.

Neuromuscular monitoring using TOF-Cuff® versus TOF-Scan®: an observational study under clinical anesthesia conditions.

BACKGROUND: Anesthesia guidelines advise objective neuromuscular monitoring. Acceleromyography, the standard technique used in clinical practice, is commonly used with the train-of-four (TOF) nerve stimulation pattern. Objective of this study was to compare the performance of two devices, TOF-Scan® and TOF-Cuff®. METHODS: This prospective, controlled observational study included patients undergoing surgery in general anesthesia with the need of neuromuscular blockade. Both neuromuscular monitoring devices were simultaneously placed on individual patients. Atracurium (0.5 mg/kg) was administered once. Main outcome measure was return time to TOF ratio ≥90%, secondary outcomes were time to TOF-ratio of 0% (during induction) and time to recovery to TOF-count of two. Results from the two devices were compared by Bland-Altman plots and one-sample t-test (P<0.05). RESULTS: Mean time to recovery to TOF ratio 90% was 79.6±13.6 min for TOF-Scan® and 70.8±12.8 min for TOF-Cuff® (P<0.001; mean bias 8.9 min, 95% CI: 5.8-12.0). Mean time to TOF-ratio 0% was 164.6±38.8 s for TOF-Scan® and 145.5±44.6 s for TOF-Cuff® (P<0.001; mean bias 19.1 s, 95% CI: 10.0-28.2). Mean time to recovery to TOF count two was 52.8±12.5 min for TOF-Scan® and 45.5±11.1 min for TOF-Cuff® (P<0.001; mean bias 7.3 min, 95% CI: 4.3-10.2). CONCLUSIONS: TOF-Cuff® consistently recorded the endpoints earlier than TOF-Scan®. Despite large intra-individual variations found with both devices, these results could be meaningful in a clinical setting.

Measuring the accuracy of propofol target-controlled infusion (TCI) before and after surgery with major blood loss.

Target-controlled infusion (TCI) is based on pharmacokinetic models designed to achieve a desired drug level in the blood. TCI's predictive accuracy of plasma propofol levels at the end of surgery with major blood loss has not been well established. This prospective observational study included adult patients (BMI 20-35 kg/m2) undergoing surgery with expected blood loss ≥ 1500 mL. The study was conducted with the Schnider TCI propofol model (Alaris PK Infusion Pump, CareFusion, Switzerland). Propofol levels were assessed in steady-state at the end of anaesthesia induction (Tinitial) and before the end of surgery (Tfinal). Predicted propofol levels (CTCI) were compared to measured levels (Cblood). Twenty-one patients were included. The median estimated blood loss was 1600 mL (IQR 1000-2300), and the median fluid balance at Tfinal was + 3200 mL (IQR 2320-4715). Heart rate, mean arterial blood pressure, and blood lactate did not differ significantly between Tinitial and Tfinal. The median bispectral index (0-100) was 50 (IQR 42-54) and 49 (IQR 42-56) at the two respective time points. At Tinitial, median CTCI was 2.2 µmol/L (IQR 2-2.45) and Cblood was 2.0 µmol/L (bias 0.3 µmol/L, limits of agreement - 1.1 to 1.3, p = 0.33). CTCI and Cblood at Tfinal were 2.0 µmol/L (IQR 1.6-2.2) and 1 µmol/L (IQR 0.8-1.4), respectively (bias 0.6 µmol/L, limits of agreement - 0.89 to 1.4, p < 0.0001). Propofol TCI allows clinically unproblematic conduct of general anaesthesia. In cases of major blood loss, the probability of propofol TCI overestimating plasma levels increases.Trial registration German Clinical Trials Register (DRKS; DRKS00009312).

Placement of TOF-Cuff® on the lower leg for neuromuscular and blood pressure monitoring during anesthetic induction for shoulder surgeries.

PURPOSE: The aim of this study was to compare two devices for neuromuscular monitoring during anesthetic induction. TOF-Cuff® was installed on the lower leg stimulating the tibial nerve, while the more conventional TOF-Scan® was installed over the ulnar nerve at the wrist. Methods Twenty adult patients were enrolled in this prospective, controlled study. Train-of-four (TOF) was recorded every 15 s until TOF ratio of 0%. Mean arterial blood pressure (MAP) was assessed with TOF-Cuff® and with standard anesthesia monitoring from the brachial artery. MAP was measured before and after anesthetic induction. Time to TOF ratio = 0% was compared with one-sample t test and Bland-Altman plots. Results Patients received 0.53 ± 0.09 mg atracurium per kg body weight intravenously. Mean time to TOF ratio = 0% was 150.8 s (± 43.7) for TOF-Scan®, and 174.4 s (± 42.7) for TOF-Cuff® (p = 0.1356). Bias was - 15.9 (95% confidence interval - 37.5 to 5.6) with 95% limits of agreement of - 95.2 to 63.3. Twenty-five percent of the patients had a technical issue with a TOF-Cuff® measurement. For MAP, mean difference was 1.4 (95% confidence interval - 2.4 to 5.2) with 95% limits of agreement of - 22.7 to 25.5. Conclusion The time from administration of a common dose of atracurium to a TOF ratio of 0% assessed with TOF-Cuff® stimulating the tibial nerve compared to TOF-Scan® stimulating the ulnar nerve showed large limits of agreement in Bland-Altman analysis. There was a high failure rate with TOF-Cuff® measurements on the lower leg.

Predictors of a Successful Bipolar Radiofrequency Endometrial Ablation.

Introduction The study's objectives were to determine the success rate following radiofrequency endometrial ablation to treat abnormal menstrual bleeding and to assess risk factors for failure of the method. Materials and Methods 195 women who were treated with bipolar radiofrequency endometrial ablation between 01/2009 and 06/2016 were included in this prospective cohort study. Postoperative data from 187 women were collected at a median of 17.5 months (IQR 4.5-34.9; 1-82). Multivariate analyses of risk factors were performed. Success was defined as amenorrhoea or spotting. Results Patient characteristics were as follows: mean age 44 years (SD ± 5), median parity 2 (IQR 2-3), median hysterometer 8.7 cm (SD ± 1.1), and median BMI 23.5 kg/m 2 (IQR 21-27). 30 patients (19.5%) had intramural masses that could be measured with ultrasound. Postoperative success rate was 86.1%. 10 patients (5%) had a hysterectomy postoperatively - 6 for heavy bleeding, 3 due to prolapse, and 1 due to dysmenorrhoea. Multivariate analyses showed the presence of intramural masses in women < 45 years was a significant risk factor for therapeutic failure (p = 0.033; 95% CI 1.08-12.57), with an increased risk of hysterectomy (OR 7.9, 95% CI 1.2-52.7, p = 0.033). Conclusion Bipolar radio frequency endometrial ablation was highly successful in the absence of an intramural mass (88%). Even smaller intramural fibroids (DD: adenomyomas of a median of 15 mm) reduce the success rate (76%), which is why preoperative ultrasound is recommended. In the presence of intramural masses, the risk of a hysterectomy for women < 45 years increases eightfold.

Subcutaneous botulinum toxin type A injections for provoked vestibulodynia: a randomized placebo-controlled trial and exploratory subanalysis.

BACKGROUND: Previous studies using botulinum toxin type A (BT) to treat provoked vestibulodynia (PVD) reported conflicting findings, possibly attributable to singular injections or low doses. We assessed PVD treatment effectiveness with high-dose single injections of BT (50 or 100 units) versus placebo, and then repeat BT 100 U injections over 6 months. METHODS: This was a randomized, double-blind, three-arm, placebo-controlled study with 33 PVD patients. BT 50 U (arm A), 100 U (arm B) or saline (arm C) were injected subcutaneously into the dorsal vulvar vestibulum and pain was assessed after 3 months. The investigation proceeded as an unblinded exploratory analysis, in which symptomatic patients received a BT 100 U injection. Symptomatic patients in arm C received a second BT 100 U injection at the 6-month visit. Symptoms were measured at 3-month cycles using: (1) cotton swab-provoked visual analogue scale (VAS), (2) von Frey filaments, and (3) Marinoff dyspareunia scale. RESULTS: The three groups were comparable in terms of demographics and baseline clinical characteristics. Three months after the initial injection, no significant differences in pain were observed among the study arms, yet significant improvements occurred within all groups using the von Frey filaments test. Results from the exploratory analyses showed repeat injections of 100 U BT over 6 months led to significant pain reduction (VAS and von Frey filaments). Fifty-eight percent (7/12) of patients assessable after repeat injections were symptom-free or had ≥ 2 VAS reduction. Adverse events were minor and no serious adverse events occurred during the RCT or exploratory analysis. CONCLUSIONS: PVD symptoms after one subcutaneous injection of BT (50 or 100 units) did not significantly differ compared to placebo, yet all three study arms experienced a reduction in pain 3 months after a single injection. Exploratory analyses indicated that repeat high-dose BT injections may significantly reduce pain over 6 months. TRIAL REGISTRATION: This trial was registered with the Swiss Medical Agency (reference number: 2007DR2102) in 2007.

The traumatic acromion fracture: review of the literature, clinical examples and proposal of a treatment algorithm.

PURPOSE: Traumatic acromion fractures are rare and typically occur in patients with multiple fractures, which often delays diagnosis. Limited guidance exists on the treatment of these fractures. We present a review of the literature from the last 20 years and describe our experience in treating five patients-two conservatively and three with open reduction and internal fixations (ORIF). METHODS: We used the U.S. National Library of Science database, MEDLINE®, to search for all pertinent publications from January 1999 to December 2017. Included were retrospective or prospective studies, including case series and case reports, describing treatment for traumatic acromion fractures and clinical and/or radiological outcomes. For our case reports, we present five patients with traumatic acromion fractures who were treated at our institution between 2013 and 2017. RESULTS: Through our review of 14 publications, we found that current recommendations are often based on a limited number of cases. No gold standard to treat these fractures exists. Most authors recommend anatomic reconstruction, especially for dislocated fractures, persistent symptomatic non-unions or additional injuries to the superior shoulder suspensory complex. There is no clear trend in terms of the operative technique. With regard to our five clinical examples that were all initially treated conservatively, two were successful and three eventually required reconstruction with ORIF. Based on the findings of this review, we proposed a treatment algorithm for traumatic acromion fractures. CONCLUSIONS: A classification system providing clear guidance on treatment options is needed. Although the non-union rate with conservative treatment is relatively high, it is not always painful or limiting to shoulder function, especially in elderly or less active patients. Fixation seems to be a more suitable treatment option for active patients who are more likely to require revision of symptomatic non-unions.

Short- and long-term outcomes following hallux-valgus correction: a modified Kramer osteotomy.

BACKGROUND: Short- and long-term assessments were performed of a modification to the Kramer osteotomy that developed to stabilize the metatarsal head using an angular implant, the LINK(®) internal hallux fixator (Waldemar LINK GmbH & Co. KG, Hamburg, Germany). METHODS: For this retrospective study, radiological assessments were used to measure outcomes in 72 feet with hallux valgus treated from 2006 to 2011. The hallux-valgus angle, the intermetatarsal angle between the first and second intermetarsal shaft axes, and the distal metatarsal articular angle were measured at short- and long-term intervals. Long-term clinical assessments included results of the Foot Function Index and the American Orthopedic Foot and Ankle Society Forefoot Score. RESULTS: Of the 72 feet treated, 12 were done as bilateral operations. Fifty-five patients at a mean age of 52 years (±12; range 22-78) were included in short-term assessments. Significant improvements in angular measurements were made (p < 0.001) between baseline and 3 month assessments. Three postoperative complications occurred and 40 % (29/72) of the implants were eventually removed. Fifty-five of the 72 feet were available for long-term assessments at a median of 5 years postoperatively (IQR 5-7; range 3-9). No significant loss of correction was detected (p = 0.373). Clinical assessments indicated successful outcomes in 86 % (47/55) of the feet, with slightly better results in older patients (p = 0.033; OR 1.1, CI 95 % 1.01-1.15). CONCLUSION: This technique can achieve normal angular configuration, even with severe deformities, without significant long-term loss of correction. Patients should be informed of potential discomfort necessitating hardware removal, although the likelihood of complications is low. LEVEL OF EVIDENCE: Level III study.

Are mast cells still good biomarkers for bladder pain syndrome/interstitial cystitis?

PURPOSE: ESSIC identifies mast cell infiltrates of detrusor muscle as a diagnostic criterion for bladder pain syndrome/interstitial cystitis. However, an increased mast cell count is also characteristic of overactive bladder syndrome. The lack of uniformity in mast cell detection methods hampers data comparison. Using state-of-the-art techniques we investigated whether mast cells differ among bladder conditions. MATERIALS AND METHODS: We analyzed bladder biopsies from 56 patients, including 31 with bladder pain syndrome/interstitial cystitis with (12) or without (19) Hunner lesions, 13 with overactive bladder syndrome and 12 without bladder symptoms to determine the quantity, location, distribution and activation of mast cells using immunohistochemistry with anti-mast cell tryptase. Patients were allocated to study groups by key bladder symptoms commonly used to define conditions (pain and major urgency). RESULTS: Subepithelial mast cell localization (p <0.001) and an increased detrusor mast cell count (p = 0.029) were characteristic of bladder pain syndrome/interstitial cystitis with Hunner lesions. The optimal cutoff of 32 detrusor mast cells per mm(2) achieved only 68% accuracy with 38% positive predictive value. No difference was observed between bladder pain syndrome/interstitial cystitis without Hunner lesions and overactive bladder syndrome. Patient groups differed in lymphocyte infiltration (p = 0.001), nodular lymphocyte aggregates (p <0.001) and urothelium integrity (p <0.001). CONCLUSIONS: Subepithelial mast cell distribution was characteristic of bladder pain syndrome/interstitial cystitis with Hunner lesions. Detrusor mastocytosis had poor predictive value for bladder pain syndrome/interstitial cystitis. Mast cell assessment did not distinguish bladder pain syndrome/interstitial cystitis without Hunner lesions from overactive bladder syndrome.