Biomechanical Effects of Hindfoot Alignment in Supination External Rotation Malleolar Fractures: A Human Cadaveric Model.

BACKGROUND: Pressure distribution in the ankle joint is known to be dependent on various factors, including hindfoot alignment. We seek to evaluate how hindfoot alignment affects contact pressures in the ankle joint in the setting of supination external rotation (SER) type ankle fractures. METHODS: SER fractures were created in 10 human cadaver lower extremity specimens, simulating progressive stages of injury: without fracture (step 0), SER fracture and intact deltoid ligament (step 1), superficial deltoid ligament disruption (step 2), and deep deltoid ligament disruption (step 3). At each step, varus and valgus alignment was simulated by displacing the calcaneal tuberosity 7 mm medial or lateral. Each limb was axially loaded following each osteotomy at a static load of 350 N. The center of force (COF), contact area (CA), and peak contact pressure (PP) under load were measured, and radiographs of the ankle mortise were taken to analyze the medial clear space (MCS) and talar tilt (TT). RESULTS: The COF (5.3 mm, P = .030) and the CA (-188.4 mm2, P = .015) changed in step 3 in the valgus hindfoot alignment compared to baseline parameters, indicating the importance of deep deltoid ligament integrity in maintaining normal ankle joint contact stress in the valgus hindfoot. These changes were not seen in the setting of varus alignment (COF: 2.3 mm, P = .059; CA -121 mm2, P = .133). PP were found to not change significantly in either varus or valgus (varus: -4.9 N, P = .132; valgus: -4 N, P = .464).The MCS demonstrated widening in step 3 compared to step 2 (0.7 mm, P = .020) in both varus and valgus hindfoot. The TT increased significantly in step 3 in the valgus hindfoot (2.8 degrees, P = .020) compared to step 0. CONCLUSION: SER-IV fractures with valgus hindfoot alignment showed significant changes in pressure distribution and radiographic parameters when compared to SER-IV fractures with varus hindfoot alignment. CLINICAL RELEVANCE: Based on this cadaver modeling study, patients with SERIV fracture with varus hindfoot alignment and complete deltoid ligament lesion may not need fracture fixation, whereas those with valgus hindfoot alignment likely need fracture fixation.

Toward Quantitative Electrodeposition via In Situ Liquid Phase Transmission Electron Microscopy: Studying Electroplated Zinc Using Basic Image Processing and 4D STEM.

High energy density electrochemical systems such as metal batteries suffer from uncontrollable dendrite growth on cycling, which can severely compromise battery safety and longevity. This originates from the thermodynamic preference of metal nucleation on electrode surfaces, where obtaining the crucial information on metal deposits in terms of crystal orientation, plated volume, and growth rate is very challenging. In situ liquid phase transmission electron microscopy (LPTEM) is a promising technique to visualize and understand electrodeposition processes, however a detailed quantification of which presents significant difficulties. Here by performing Zn electroplating and analyzing the data via basic image processing, this work not only sheds new light on the dendrite growth mechanism but also demonstrates a workflow showcasing how dendritic deposition can be visualized with volumetric and growth rate information. These results along with additionally corroborated 4D STEM analysis take steps to access information on the crystallographic orientation of the grown Zn nucleates and toward live quantification of in situ electrodeposition processes.

Accuracy of a Patient-Specific Total Ankle Arthroplasty Instrumentation.

BACKGROUND: Total ankle arthroplasty (TAA) is a preferred surgical option for end-stage ankle osteoarthritis; however, it is a demanding procedure with a higher historical rate of revision compared with ankle fusion. Patient-specific instrumentation (PSI) has been introduced to optimize prosthesis alignment and theoretically overall improve TAA outcomes. The goal of this study is to report on the experience and surgical outcomes of one implant with specific evaluation of the accuracy and reproducibility of the system with respect to prosthesis alignment and prediction of implant size. METHODS: A retrospective, multicentered study involving 4 foot and ankle fellowship-trained orthopaedic surgeon's patients undergoing TAA between January 1, 2015, and December 31, 2018, using the PROPHECY PSI system. RESULTS: 80 TAA procedures were performed. On average the postoperative tibial component alignment was 89.9 (range, 86.1-96.5) degrees in the coronal plane, with a mean sagittal alignment of 88.1 (range, 81.3-96.7) degrees. The mean deviation from neutral sagittal alignment improved from 4.9 ± 3.9 degrees preoperatively to 2.7 ± 1.7 degrees postoperatively, whereas the mean coronal alignment improved from 3.3 ± 2.5 degrees to 1.3 ± 1.1 degrees. The PSI software correctly determined the tibial implant size in 70 patients (89%). Prediction of talar implant sizing was less accurate than the tibial component, with 56 patients (71%) using the predicted sized implant. The overall implant survival at a mean follow-up of 45 months (range, 27-76) was 97.5%. CONCLUSION: We found that this PSI system accurately and reliably assisted in implant total ankle prosthesis positioning within a clinically acceptable margin and without significant outliers. Prediction of implant size was not as accurate as component orientation. LEVEL OF EVIDENCE: Level III, retrospective study.

A survey of preferences for respiratory support in the intensive care unit for patients with acute hypoxaemic respiratory failure.

BACKGROUND: When caring for mechanically ventilated adults with acute hypoxaemic respiratory failure (AHRF), clinicians are faced with an uncertain choice between ventilator modes allowing for spontaneous breaths or ventilation fully controlled by the ventilator. The preferences of clinicians managing such patients, and what motivates their choice of ventilator mode, are largely unknown. To better understand how clinicians' preferences may impact the choice of ventilatory support for patients with AHRF, we issued a survey to an international network of intensive care unit (ICU) researchers. METHODS: We distributed an online survey with 32 broadly similar and interlinked questions on how clinicians prioritise spontaneous or controlled ventilation in invasively ventilated patients with AHRF of different severity, and which factors determine their choice. RESULTS: The survey was distributed to 1337 recipients in 12 countries. Of these, 415 (31%) completed the survey either fully (52%) or partially (48%). Most respondents were identified as medical specialists (87%) or physicians in training (11%). Modes allowing for spontaneous ventilation were considered preferable in mild AHRF, with controlled ventilation considered as progressively more important in moderate and severe AHRF. Among respondents there was strong support (90%) for a randomised clinical trial comparing spontaneous with controlled ventilation in patients with moderate AHRF. CONCLUSIONS: The responses from this international survey suggest that there is clinical equipoise for the preferred ventilator mode in patients with AHRF of moderate severity. We found strong support for a randomised trial comparing modes of ventilation in patients with moderate AHRF.

Structure, processes, and initial outcomes of The Ottawa Hospital Multi-Specialist Limb-Preservation Clinic and Programme: A unique-in-Canada quality improvement initiative.

In 2017, The Ottawa Hospital initiated a unique-in-Canada quality improvement initiative by opening a novel, multi-specialist limb-preservation clinic. We sought to describe the structure, processes, and initial outcomes of the clinic and evaluate whether it is achieving its mandate of providing high-quality wound clinical care, education, and research. We conducted a descriptive prospective cohort study alongside a nested study of 162 clinic patients requiring serial assessments. There have been 1623 visits, mostly (72.2%) from outpatients. During 17.8% of visits, patients were evaluated by >1 specialist. Therapies provided most often included negative-pressure wound therapy (32.7%), biological wound dressings (21.6%), and total contact casting (18.5%). Furthermore, 1.2% underwent toe/ray amputations or skin grafting in clinic and 22.8% were initiated on antimicrobials. Mixed-effects models suggested that mean wound volumes for those requiring serial assessments decreased by 1.6 (95% confidence interval = -0.86 to -2.27) cm3 between visits. The clinic provided seven rotations to vascular surgery, infectious diseases, dermatology, and palliative care physicians; three nursing preceptorships; and two educational workshops. It also initiated provincial and national vascular health and wound care research initiatives. This study may be used to guide development of other limb-preservation clinics and programmes. Findings support that our programme is achieving its mandate.

Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients.

BACKGROUND: In critically ill, mechanically ventilated patients, daily interruption of sedation has been shown to reduce the time on ventilation and the length of stay in the intensive care unit (ICU). Data on whether a plan of no sedation, as compared with a plan of light sedation, has an effect on mortality are lacking. METHODS: In a multicenter, randomized, controlled trial, we assigned, in a 1:1 ratio, mechanically ventilated ICU patients to a plan of no sedation (nonsedation group) or to a plan of light sedation (i.e., to a level at which the patient was arousable, defined as a score of -2 to -3 on the Richmond Agitation and Sedation Scale [RASS], on which scores range from -5 [unresponsive] to +4 [combative]) (sedation group) with daily interruption. The primary outcome was mortality at 90 days. Secondary outcomes were the number of major thromboembolic events, the number of days free from coma or delirium, acute kidney injury according to severity, the number of ICU-free days, and the number of ventilator-free days. Between-group differences were calculated as the value in the nonsedation group minus the value in the sedation group. RESULTS: A total of 710 patients underwent randomization, and 700 were included in the modified intention-to-treat analysis. The characteristics of the patients at baseline were similar in the two trial groups, except for the score on the Acute Physiology and Chronic Health Evaluation (APACHE) II, which was 1 point higher in the nonsedation group than in the sedation group, indicating a greater chance of in-hospital death. The mean RASS score in the nonsedation group increased from -1.3 on day 1 to -0.8 on day 7 and, in the sedation group, from -2.3 on day 1 to -1.8 on day 7. Mortality at 90 days was 42.4% in the nonsedation group and 37.0% in the sedated group (difference, 5.4 percentage points; 95% confidence interval [CI], -2.2 to 12.2; P = 0.65). The number of ICU-free days and of ventilator-free days did not differ significantly between the trial groups. The patients in the nonsedation group had a median of 27 days free from coma or delirium, and those in the sedation group had a median of 26 days free from coma or delirium. A major thromboembolic event occurred in 1 patient (0.3%) in the nonsedation group and in 10 patients (2.8%) in the sedation group (difference, -2.5 percentage points; 95% CI, -4.8 to -0.7 [unadjusted for multiple comparisons]). CONCLUSIONS: Among mechanically ventilated ICU patients, mortality at 90 days did not differ significantly between those assigned to a plan of no sedation and those assigned to a plan of light sedation with daily interruption. (Funded by the Danish Medical Research Council and others; NONSEDA ClinicalTrials.gov number, NCT01967680.).

Assembling Mesoscale-Structured Organic Interfaces in Perovskite Photovoltaics.

Mesoscale-structured materials offer broad opportunities in extremely diverse applications owing to their high surface areas, tunable surface energy, and large pore volume. These benefits may improve the performance of materials in terms of carrier density, charge transport, and stability. Although metal oxides-based mesoscale-structured materials, such as TiO2 , predominantly hold the record efficiency in perovskite solar cells, high temperatures (above 400 °C) and limited materials choices still challenge the community. A novel route to fabricate organic-based mesoscale-structured interfaces (OMI) for perovskite solar cells using a low-temperature and green solvent-based process is presented here. The efficient infiltration of organic porous structures based on crystalline nanoparticles allows engineering efficient "n-i-p" and "p-i-n" perovskite solar cells with enhanced thermal stability, good performance, and excellent lateral homogeneity. The results show that this method is universal for multiple organic electronic materials, which opens the door to transform a wide variety of organic-based semiconductors into scalable n- or p-type porous interfaces for diverse advanced applications.

Posterior malleolus exposure.

Objectives: Posterior malleolus (PM) fractures are common in rotational ankle injuries, tibial plafond fractures, and distal third tibia fractures. Surgical indications continue to evolve as we improve our understanding of ankle and syndesmotic stability. These fractures remain technically challenging with respect to both exposure and fixation. Our biomechanical cadaveric study compared posterolateral versus modified posteromedial surgical approaches to define the following: maximal surface area exposed, and maximal screw trajectory obtainable for fixation. Methods: Twelve fresh-frozen cadaver limbs were thawed at room temperature. Posterolateral and modified posteromedial approaches were performed on each limb. Margins of exposure were marked. A 2.5 mm drill was advanced at the extreme medial and lateral extents of each exposure, standardized at 1 cm proximal to the joint line and perpendicular to the bone. Computed tomography (CT) scans were performed to identify the maximal trajectory. Limbs were stripped of soft tissue, and the exposed bony surface area was measured using a validated laser surface-scanning technique. Results: The modified posteromedial approach allowed for a larger exposed surface area compared to the posterolateral exposure (median 99% vs 64%, respectively; P < .05). The modified posteromedial approach allowed for instrumentation of up to a median of 77% of the posterior distal tibia as opposed to 46% through the posterolateral approach (P < .05). Conclusion: The modified posteromedial approach allowed for increased exposure and wider access for instrumentation of the PM when compared to the posterolateral approach. We advocate use of this approach when addressing complex PM fractures, in particular the Haraguchi type 2 fracture pattern.

Faculty Development- Is Some Better Than None?

This article was migrated. The article was marked as recommended. Introduction: With the advent of competency-based medical education there is an emphasis on formative workplace based assessment. The quality of these assessments is a concern for medical educators and their trainees. Faculty development (FD) strategies to improve assessment quality have resulted in some success. However, few faculty participate, and those who do are likely more motivated to improve, making it difficult to demonstrate a conclusive benefit. To address these weaknesses, we designed a FD initiative to improve the quality of completed in-training evaluation reports (ITERs). All faculty within a division participated. We hypothesized that clinical supervisors would improve their ITER quality based on feedback, regardless of their own motivation to do so, with a simple, point-in-time intervention. Methods: In this three-phase study, two independent raters used the Completed Clinical Evaluation Report Rating (CCERR) to assess the quality of ITERs completed by all faculty in the Division of Orthopedic Surgery at the University of Ottawa. In phase one, ITERs from the previous nine months were evaluated. In phase two, the participants were aware that their ITERs were being evaluated, but they did not receive feedback. In phase three, participants received regular feedback on their performance in the form of their mean CCERR scores. Mean CCERR scores from the different phases of the study were compared. Results: CCERR scores were similar for all three phases (one: 17.56 ± 1.02, two: 17.65 ± 0.96, three: 17.54 ± 0.75, p=0.98). Discussion and Conclusions: There was no evidence in our study that participants' improved their ITER quality despite being aware that they were being evaluated and/or receiving feedback. Potentially, this was related to a lack of motivation. Alternatively, the intensity and/or frequency of the feedback may have been inadequate to create change. These results raise concerns that some faculty development may not necessarily be better than none.

Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

BACKGROUND: Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS: We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION: The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION: ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

The fabrication of color-tunable organic light-emitting diode displays via solution processing.

Electroluminescent devices based on organic semiconductors have attracted significant attention owing to their promising applications in flat-panel displays. The conventional display pixel consisting of side-by-side arrayed red, green and blue subpixels represents the mature technology but bears an intrinsic deficiency of a low pixel density. Constructing an individual color-tunable pixel that comprises vertically stacked subpixels is considered an advanced technology. Although color-tunable organic light-emitting diodes (OLEDs) have been fabricated using the vacuum deposition of small molecules, the solution processing of conjugated polymers would enable a much simpler and inexpensive manufacturing process. Here we present the all-solution processing of color-tunable OLEDs comprising two vertically stacked polymer emitters. A thin layer of highly conducting and transparent silver nanowires is introduced as the intermediate charge injection contact, which allows the emission spectrum and intensity of the tandem devices to be seamlessly manipulated. To demonstrate a viable application of this technology, a 4-by-4 pixelated matrix color-tunable display was fabricated.

A Coding System for Reoperations Following Total Ankle Replacement and Ankle Arthrodesis.

BACKGROUND: Repeated surgery can be a measure of failure of the primary surgery. Future reoperations might be avoided if the cause is recognized and procedures or devices modified accordingly. Reoperations result in costs to both patient and the health care system. This paper proposes a new classification system for reoperations in end-stage ankle arthritis, and analyzes reoperation rates for ankle joint replacement and arthrodesis surgeries from a multicenter database. METHODS: A total of 213 ankle arthrodeses and 474 total ankle replacements were prospectively followed from 2002 to 2010. Reoperations were identified as part of the prospective cohort study. Operating reports were reviewed, and each reoperation was coded. To verify inter- and intraobserver reliability of this new coding system, 6 surgeons experienced in foot and ankle surgery were asked to assign a specific code to 62 blinded reoperations, on 2 separate occasions. Reliability was determined using intraclass correlation coefficients (ICCs) and proportions of agreement. RESULTS: Of a total of 687 procedures, 74.8% (514/687) required no reoperation (Code 1). By surgery type, 14.1% (30/213) of ankle arthrodesis procedures and 30.2% (143/474) of ankle replacement procedures required reoperation. The rate for reoperations surrounding the ankle joint (ie, Codes 2 and 3) was 9.9% (21/213) for ankle arthrodesis versus 5.9% for ankle replacement (28/474). Reoperation rates within the ankle joint (ie, Codes 4 to 10) were 4.7% (10/213) for ankle arthrodesis and 26.1% (124/474) for ankle replacement. Overall, 0.9% (2/213) of arthrodesis procedures required reoperation outside the initial operative site (Code 3), versus 4.6% (22/474) for total ankle replacement. The rate of reoperation due to deep infection (Code 7) was 0.9% (2/213) for arthrodesis versus 2.3% (11/474) for ankle replacement. Interobserver reliability testing produced a mean ICC of 0.89 on the first read. The mean ICC for intraobserver reliability was 0.92. For interobserver, there was 87.9% agreement (804/915) on the first read, and 87.5% agreement (801/915) on the second. For the intra observer readings, 88.5% (324/366) were in agreement. CONCLUSIONS: The new coding system presented here was reliable and may provide a more standardized, clinically useful framework for assessing reoperation rates and resource utilization than prior complication- and diagnosis-based classification systems, such as modifications of the Clavien Dindo System. Analyzing reoperations at the primary site may enable a better understanding of reasons for failure, and may therefore improve the outcomes of surgery in the future. LEVEL OF EVIDENCE: Level III, retrospective comparative cohort study based on prospectively collected data.

Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a ß-TCP-Collagen Matrix.

BACKGROUND: Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (ß-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. METHODS: Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/ß-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/ß-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. RESULTS: Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/ß-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/ß-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/ß-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections. CONCLUSIONS: Application of rhPDGF-BB/ß-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting. LEVEL OF EVIDENCE: Level I, prospective randomized study.

Patient expectation and satisfaction as measures of operative outcome in end-stage ankle arthritis: a prospective cohort study of total ankle replacement versus ankle fusion.

BACKGROUND: Current operative outcome scales are based on pain and function, such as the Ankle Osteoarthritis Scale (AOS). Outcomes based on patient expectation and satisfaction may be more useful. The purpose of this prospective cohort study was to evaluate associations between patient expectation, satisfaction, and outcome scores for ankle fusion and total ankle replacement (TAR). METHODS: In total, 654 ankles in 622 patients were analyzed at a mean of 61 months. Patient expectation and satisfaction with symptoms were quantified pre- and postoperatively using the Musculoskeletal Outcomes Data Evaluation and Management Scale questionnaires from the American Academy of Orthopaedic Surgeons, while function was quantified using the AOS. RESULTS: Patients undergoing ankle replacement had a higher preoperative expectation score (79; 95% confidence interval [CI], 77-81) compared with those undergoing ankle fusion (72; 95% CI, 68-75). Preoperative expectation scores correlated weakly with AOS scores (R (2) = 0.02) and with the "expectations met" score for ankle fusion (R (2) = 0.07) but not for ankle replacement (R (2) < 0.01). Satisfaction scores were similar for ankle fusion and ankle replacement at follow-up, but a greater number of ankle replacement patients showed improvement in satisfaction (84% vs 74%, P < .005). Higher satisfaction at final follow-up was associated with better expectations met and greater improvement in AOS outcome scores for both ankle fusion and ankle replacement. Expectations met and AOS scores at follow-up correlated for ankle fusion (R (2) = 0.38, P < .0001) and ankle replacement (R (2) = 0.31, P < .0001). CONCLUSIONS: Patients undergoing TAR had higher expectation scores prior to surgery than those undergoing ankle fusion. Expectations may be more likely to be met by ankle replacement compared with ankle fusion. Ankle replacement patients were more likely to report improved satisfaction scores after surgery. Preoperative expectation scores showed little correlation with preoperative AOS scores, indicating that expectation is independent of pain and function. However, postoperative expectations met and satisfaction scores were strongly associated with AOS scores at follow-up. Better preoperative patient education may change expectations and requires study. LEVEL OF EVIDENCE: Level II, prospective cohort study.

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial.

BACKGROUND: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients. METHODS/DESIGN: The non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium-free days; highest RIFLE score; days until discharge from the intensive care unit (within 28 days); days until the participant is without mechanical ventilation (within 28 days); and proportion of patients with a major cardiovascular outcome. Explorative outcomes will be: all cause mortality at 28 days after randomisation; days until discharge from the intensive care unit; days until the participant is without mechanical ventilation; days until discharge from the hospital; organ failure.Trial size: we will include 700 participants (2 × 350) in order to detect or reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%). DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients. TRIAL REGISTER: ClinicalTrials.gov NCT0196768, 09.01.2014.

Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study.

BACKGROUND: Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy. The proximal chevron osteotomy is commonly used but is technically difficult. This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle. METHODS: This prospective, randomized multicenter (three-center) study was based on the clinical outcome scores of the Short Form-36, the American Orthopaedic Foot & Ankle Society forefoot questionnaire, and the visual analog scale for pain, activity, and patient satisfaction. Subjects were assessed prior to surgery and at three, six, and twelve months postoperatively. Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure. RESULTS: No significant differences were found for any of the patients' clinical outcome measurements between the two procedures. The proximal opening wedge osteotomy was found to lengthen, and the proximal chevron osteotomy was found to shorten, the first metatarsal. The intermetatarsal angles improved (decreased) significantly, from 14.8° ± 3.2° to 9.1° ± 2.9 (mean and standard deviation) after a proximal opening wedge osteotomy and from 14.6° ± 3.9° to 11.3° ± 4.0° after a proximal chevron osteotomy (p < 0.05 for both). Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy (mean and standard deviation, 67.1 ± 16.5 minutes compared with 69.9 ± 18.6 minutes; p = 0.510). CONCLUSIONS: Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain, satisfaction, and function. The proximal opening wedge osteotomy lengthens, and the proximal chevron osteotomy shortens, the first metatarsal. The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis.

BACKGROUND: To reduce fusion nonunion, autogenous bone graft is often incorporated into foot and ankle fusion procedures. B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 µg B2A/cm(3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis. The purpose of this study was to perform a multicenter prospective randomized pilot clinical trial designed to compare the safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. METHODS: This study was a multicenter, prospective, randomized, pilot clinical trial designed to compare safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. Twenty-four patients were enrolled and randomized (1:1) into 2 groups: autogenous bone graft control and B2A-granule. Primary outcome measures at 6 months (with follow-up at 9 and 12 months) included radiographic fusion assessed by computerized tomography and Ankle Osteoarthritis Scale scores for pain and disability. RESULTS: Radiographic fusion success rates were similar in both groups (100% in the B2A-granule group, 92% autograft). Both the B2A-granule group and the autograft group had improvements in the pain and disability scores over the course of the study. Graft harvest-site pain affected only autograft-treated patients. There were no adverse events attributed to the graft material in either the B2A-granule or autograft group. CONCLUSION: The results of this pilot study are supportive of a larger clinical trial to assess the safety and efficacy of B2A-granule as a bone graft substitute in foot and ankle fusions. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Kinematic analysis of the agility total ankle during gait.

BACKGROUND: With the increasing use of total ankle prostheses, kinematic analysis of these implants is important to our understanding of their specific biomechanics. Fluoroscopic analysis as used in this study has distinct advantages over previous experimental approaches and allows kinematic determination in vivo of dynamic weightbearing motions. METHODS: Ten patients with unilateral Agility (Depuy, A Johnson & Johnson Company, Warsaw, IN) total ankle replacements were tested using video fluoroscopy in weightbearing dynamic gait conditions. Their prosthetic ankle and normal ankle kinematics were then analyzed by computer with two-dimensional and three-dimensional model-fitting techniques. RESULTS: All of the total ankle prostheses in this study demonstrated less than 3.5 mm of posterior-to-anterior translation from heel strike to toe-off. In comparison, more variability was seen in posterior-to-anterior motion of the normal contralateral ankles, with three ankles translating more than 6 mm. When inversion and eversion and internal and external rotation of the ankle were measured, wide variations were seen among patients. CONCLUSIONS: While the relative incongruence theoretically decreases the shear stresses transmitted to the bone-prosthesis interface, it does allow more inversion-eversion and rotational freedom that can lead to edge loading and higher contact stresses. Despite good medium-term results having been published for this prosthesis, polyethylene wear and osteolysis have been observed. Further studies looking at the effect of the inversion and eversion and rotational freedom on polyethylene wear and prosthesis survival will assist in our understanding of the factors leading to successful outcome of total ankle prostheses.