bluuebunny/crossref_metadata_2025_split huggingface dataset:
Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management
Authors: Backer Vibeke , Ellery Adam , Borzova Sylvia , Lane Stephen , Kleiberova Magda , Bengtsson Peter , Tomala Tadeusz , Basset-Stheme Dominique , Bennett Carla , Lindner Dirk , Meiners Arthur , Overend Tim 
Published: September 2018

Introduction: In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted. Methods: This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions. Results: The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment. Conclusion: In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.
The effect of disease modifying therapies on CD62L expression in multiple sclerosis
Authors: Voortman Margarete Maria , Greiner Paul , Moser Daniel , Stradner Martin Helmut , Graninger Winfried , Moser Adrian , Haditsch Bernd , Enzinger Christian , Fuchs Siegrid , Fazekas Franz , Fessler Johannes , Khalil Michael 
Published: September 2018

Background The increasing armamentarium of disease-modifying therapies in multiple sclerosis is accompanied by potentially severe adverse effects. The cell-adhesion molecule CD62L, which facilitates leukocyte extravasation, has been proposed as a predictive marker for treatment tolerability. However, pre-analytical procedures might impact test results, thereby limiting its clinical usability. Whether the immediate analysis of CD62L expression of peripheral blood mononuclear cells can aid treatment decision making is yet unclear. Objective To investigate the effect of various disease-modifying therapies in multiple sclerosis on CD62L expression of CD3+CD4+ peripheral blood mononuclear cells in freshly collected blood samples. Methods We collected peripheral blood samples from patients with clinically isolated syndrome and multiple sclerosis (baseline/follow up n = 234/ n = 98) and healthy controls ( n = 51). CD62L+CD3+CD4+ expression was analysed within 1 hour by fluorescence-activated cell sorting. Results CD62L+CD3+CD4+ expression was significantly decreased in patients treated with natalizumab ( n = 26) and fingolimod ( n = 20) and increased with dimethyl-fumarate ( n = 15) compared to patients receiving interferon/glatiramer acetate ( n = 90/30) or no disease-modifying therapies ( n = 53) and controls ( n = 51) ( p<0.001). CD62L expression showed temporal stability during unchanged disease-modifying therapy usage, but increased after natalizumab withdrawal and decreased upon fingolimod introduction. Conclusion CD62L+CD3+CD4+ expression is altered in patients treated with different disease-modifying therapies when measured in freshly collected samples. The clinical meaning of CD62L changes under disease-modifying therapies warrants further investigation.
Clinical and Radiographic Outcomes of Midfoot Arthrodesis Using Different Fixation Methods
Authors: Bejarano-Pineda Lorena , Huh Jeannie , DeOrio James , Lampley Alexander , Easley Mark 
Published: September 2018

Category: Midfoot/Forefoot Introduction/Purpose: Midfoot arthritis is a disabling condition, causing chronic foot pain and functional disability. The goals of midfoot arthrodesis are to a plantigrade, stable, and pain-free foot. The procedure can be technically demanding and associated with a number of complications. The use of midfoot-specific plate fixation has become more popular as an alternative to screw-only fixation. The purpose of this study was to compare the clinical and radiographic outcomes following midfoot arthrodesis using different fixation methods. Methods: This was a retrospective study of all midfoot arthrodeses performed at a single institution between January 2005 and December 2014. Patients qualified if they had a minimum of 12 months follow-up, specifically with patient-reported outcomes. Demographic and surgical information were collected. Final post-operative outcomes were reviewed and consisted of patient-reported functional measures, union rate, complications, and radiographic outcomes. Patient-reported functional measures included the American Orthopedic Foot and Ankle Score (AOFAS) midfoot scale, Visual Analogue Scale (VAS) for pain, and Lower Extremity Functional Score (LEFS). Radiographic outcomes included alignment in the antero-posterior (AP) and lateral views, as measured by the talo-first metatarsal angle during the pre-operative and final follow-up visits. Outcomes were compared among the following groups: Screw fixation group (SFG), plate fixation group (PFG), and combined fixation group (CFG), which had screw and plate fixation. Results: A total of 79 midfoot fusions in 75 patients had a mean follow-up of 61 months (range 13-122) with patient-reported outcome measures. At final follow-up, the SFG had a higher median LEFS (72.5 versus 53 in the PFG and 56 in the CFG; p>0.1) and a higher mean AOFAS score (87 versus 78 in the PFG and 77 in the CFG; p>0.15). The complication and nonunion rate was highest in the PFG, with 13 (50%) and 4 (50%) cases, respectively; however, the differences were not statistically significant. The talo-first metatarsal angle improved in all three groups from a median of 6.4 degrees pre-operatively to 3.9 degrees on final post-operative imaging. Conclusion: Although not statistically significant, there was a trend towards higher patient-reported outcomes, union rate, and less complication rate in midfoot fusions treated with screw fixation compared to plate fixation and combined fixation. There was no difference in radiographic correction among the difference fixation methods. Although new techniques and implants continue to be introduced, we found no significant difference in outcomes when compared to the traditional technique of screw fixation.
Clinical and Radiological Outcomes of Transfibular Total Ankle Arthroplasty at 2-years Follow-up
Authors: Granata Francesco , Maccario Camilla , Manzi Luigi , Tan Eric , Usuelli Federico Giuseppe 
Published: September 2018

Category: Ankle Arthritis Introduction/Purpose: Ankle arthritis is a highly limiting pathology that causes pain and functional limitation with subsequent deterioration of quality of life. With recent advances in surgical instrumentation and techniques, prosthetic replacement of the ankle has proved to be a valid alternative to arthrodesis with comparable outcomes. The purpose of this study was to evaluate clinical and radiological findings in a transfibular total ankle replacement with two years follow-up. Methods: This prospective study included 59 patients who underwent transfibular total ankle arthroplasty from May 2013 to December 2015. The mean age was 51.6 ± 13.4 years. All patients were followed for at least 24 months postoperative with an average follow-up of 42.0 ± 23.5 months. Patients were assessed clinically and radiologically preoperatively and at 6, 12, and 24 months postoperatively. Results: At 24 months, patients demonstrated statistically significant improvement in the American Orthopaedic Foot and Ankle Society score from 33.6 to 88.1 (P<0.01), VAS scale from 79.3 to 14.0 (P<0.01) and SF-12 Physical and Mental Composite Scores from 29.9 and 44.6 to 74.4 and 95.3, respectively (P<0.01). Ankle dorsiflexion and plantarflexion improved from 5.5 and 8.8 degrees to 24.2 and 20.0 degrees, respectively (P<0.01). Radiographically, patients demonstrated neutral alignment of the ankle with a tibio-talar ratio of 34.9 ± 9.2 and hindfoot alignment view angle of 1.2 ± 7.0 degrees. No patient demonstrated any radiographic evidence of tibial or talar lucency at 24 months. Seven patients underwent reoperation for removal of symptomatic hardware; one patient developed a postoperative prosthetic infection requiring placement of an antibiotic spacer. Conclusion: This study demonstrates that transfibular total ankle replacement is a safe and effective option for the patients for ankle arthritis with improvements in patient-reported outcomes, range of motion, and radiological parameters. However, further studies are required to determine the mid- and long-term performance of these implants.
External Fixation in the Emergency Department Is Equally Efficacious to Placement in the Operating Room
Authors: O’Donnell Seth , Shah Kalpit , Gil Joseph , Johnson Joseph , Hayda Roman , Born Christopher 
Published: September 2018

Category: Trauma Introduction/Purpose: Pilon and unstable ankle fractures are often treated initially with an external fixator (ex-fix) due to soft tissue concerns. Typically, the second stage involves open reduction internal fixation of the fracture as the definitive management. Ex-fix application in the emergency department (ED) has been described previously. We aimed to determine if an ex-fix applied in the ED would have any difference in rate of ex-fix revision, deep infection, and hospital length of stay when compared to an ex-fix that is applied in the operating room (OR). Methods: This is a retroscpective, case-cohort study performed at an urban, level-1 trauma center. Using CPT codes in our billing database, we identified all patients from 2011-2015 who had operative fixation of pilon (AO classification 43B or 43C) or unstable ankle fractures (AO classification 44C) and had application of an ex-fix (either ED or OR) prior to definitive fixation. Patients with open injury, those placed in ex-fix at outside institutions and those treated definitively with ex-fix were excluded. Results: Ninety-six patients met the inclusion criteria. Average age was 47 years and 54 (56%) were male. Thirty-three patients had ex-fix placed in the OR and 63 patients had ex-fix placed in the ED. Post-surgical complications (prominent implant, nonunion, deep infection, DVT, loss of reduction) were seen in 6/33 in the ED and 8/63 in the OR group (χ2=0.44, p=0.51). Deep infections occurred in 2/33 OR ex-fix and 5/63 ED ex-fix patients (χ2=0.137, p=0.71, OR= 1.4 [95% CI = 0.25 to 7.5]). Revision ex-fix for loss of reduction was performed 4/33 in the OR group and 10/63 in the ED ex-fix group (χ2=0.296, p=0.59). Mean length of stay was 14 days for the OR and 13 days for the ED group (p=0.35). Conclusion: We found no significant difference in post-surgical complications (surgical or infectious) or ex-fix revision rates for an ex-fix placed in ED compared to one placed in the OR. Total hospital days were similar in both groups. Prospective studies are needed to validate this method of provisional stabilization in the ED; however, these results indicate that the ED ex-fix is equally efficacious to an OR ex-fix.
Preoperative Picture Improves Postoperative Satisfaction in Bunion Surgery
Authors: Taylor Michel 
Published: September 2018

Category: Bunion Introduction/Purpose: Hallux valgus (HV) is the most common conditions affecting the forefoot. Typically, the patient’s main concern is a prominent medial eminence (bunion) with difficulty with shoe wear and the cosmetic appearance of the toe. Patient satisfaction following HV correction surgery is between 73-94% however a poor cosmetic result can have a negative impact on the post-operative outcome. There is surprisingly a dearth of knowledge in the forefoot literature exploring the impact of cosmesis on the subjective outcome following HV surgery. The purpose of this prospective, blinded, randomized trial is to determine whether showing patients a preoperative photograph would improve post-operative satisfaction following HV corrective surgery. Methods: Patients undergoing HV corrective surgery were randomized to a picture group (P) or no picture group (NP). Inclusion criteria were patients over 18 and a diagnosis of HV. Pre-operatively, all patients had a picture taken of the operative foot. Patients were seen in follow up at 3 and 6 weeks and 3 months. P-group patients were shown the picture by the research assistant for 5 minutes at each visit. Patients completed the FFI and FAOS pre-operatively and at each post-operative visit. Patients also completed a satisfaction questionnaire at each post-operative visit which included a 5-point scale addressing overall satisfaction, satisfaction with the appearance of the foot and whether they would undergo the procedure again. Pre-operative and post-operative HVA and IMA were recorded by a fellowship trained orthopaedic surgeon not involved in the patient’s care. The operative surgeon was blinded to the treatment groups. Results: 29 patients were enrolled in the study (15P). No difference with respect to age, gender, smoking, presence of comorbidities, underlying diagnosis, HVA or IMA, FFI or FAOS. At 3 months, patients in the picture group were more likely to be “completely satisfied” with the appearance of their foot and this difference was statistically significant (p<0.05). There were no differences between treatment groups with respect to post-operative HVA, IMA, FAOS, or FFI. Conclusion: Hallux valgus corrective surgery is a very successful procedure with high post-operative patient satisfaction. Frequently reminding a patient of the pre-operative appearance of their foot, through the use of photographs, appears to have a beneficial impact with regards to patient satisfaction in the early post-operative period.
Osteochondral Autograft Transfer Combined with Periarticular Osteotomy for the Treatment of Osteochondral Defect of the Talus in Varus Ankle
Authors: Zhu Yuan 
Published: September 2018

Category: Ankle Introduction/Purpose: Osteochondral lesion of the talus (OLTs) is among the most common foot and ankle disorders. Varus ankle malalignment causes stress concentration on medial side of the joint, resulting in OLTs and osteoarthritis. For large symptomatic OLTs (> 15 mm in diameter) involving posteromedial aspect of talar dome, osteochondral autograft transplantation is usually warranted. This article highlights the distal tibial double osteotomy for the management of patient with concomitant large OLTs and varus ankle malalignment. Methods: From January 2012 to July 2015, 15 patients (8 males, 7 females) received the surgery in our department. The average age was 55.4 (range, 34 to 69) years old. Oblique medial malleolar osteotomy was performed to expose the talar lesion, following by osteochondral autograft transplantation and distal tibial opening-wedge osteotomy. Weight bearing X-rays were obtained for the measurement of tibial articular surface (TAS) angle and tibial lateral surface (TLS) angle. The American Orthopaedic Foot and Ankle Society-Ankle and Hindfoot (AOFAS-AH) questionnaires and Visual Analog Scale (VAS) were evaluated for ankle function. In 5 cases arthroscopy was performed 12 months postoperatively and the cartilage repair was assessed with the criteria of the International Cartilage Repair Society. Results: Thirteen patients completed the follow-up with a mean of 21.2 months. The average talar lesion was 170.0mm2, and the average depth was 11.4 mm. The mean time of bone healing was 8.5 weeks. No patient reported donor site morbidity by the last follow-up. The mean AOFAS-AH score and VAS score improved from 53 to 90 points (p < 0.05), 6.7 to 1.9 points (p < 0.05), respectively. The mean TAS angle improved from 83.1 to 90.3 degrees (p < 0.05). The radiolucent area of the cysts disappeared on the plain radiographs in all cases. The mean International Cartilage Repair Society arthroscopic score from follow-up arthroscopy was (9±1) points. Conclusion: The use of osteochondral autograft transfer combined with supramalleolar osteotomy is an effective option for the treatment of osteochondral defect of the talus in varus ankle. It provides excellent visualization of the talar defect and favorable biomechanical environment for the ankle joint.
Surgical versus non surgical management of Geriatrics ankle fractures. A Systematic Review and Meta-analysis
Authors: Alhammoud Abduljabbar , Khamis Karim Mahmoud , Mekhaimar Mohamed Maged 
Published: September 2018

Category: Trauma Introduction/Purpose: Ankle fractures are common orthopedics injuries especially in elderly. Bone quality, activity, and other comorbidities play a role in the management of ankle fracture in older age group. Conservative treatment by casting with or without reduction consider valid option whereas the open reduction and internal fixation still the stander of care for all age groups. This review aims to provide evidence-based difference between surgical and non-surgical management of geriatrics ankle fracture in regards to healing, complication and functional outcome. Methods: Relevant comparative studies in English literature were identified up to October 2017 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic-based search on MEDLINE (PubMed), EMBASE, Google Scholar and Cochrane databases, and hand searching of abstracts in orthopedics, trauma and foot and ankle journals. The research team systematically reviewed published studies according to the following criteria:(1) subjects whom sustained ankle fractures with age above 50 years;(2) the intervention was done through surgical management (open reduction and internal fixation) or conservative management (closed reduction and casting or casting alone) (3) the study reported at least one desirable outcome(non-union/mal-union rate, hospital stay, period on cast, mortality, re-admission rate, functional outcome, complication rate)(4) followed up at least one year after surgical /conservative management. The data analysis was done by Comprehensive meta-analysis software using a random-effect model and SPSS 22. Statistical heterogeneity across the studies was tested using I2. Results: The non-union rate in surgical group was significantly less than conservative group, (OR: 0.127, 95% CI: [0.055, 0.292], [P <0.001])and the mal-union was similarly less in surgical group (OR: 0.128, 95% CI: [0.063, 0.262], [P <0.001]). No difference in the hospital stays detected between two groups and similarly in re-admission rate. No difference in the period in cast reported between two groups. The return to pre-injury level was better in surgery group comparing to surgical one, whereas no difference in patient satisfaction was reported between two group. The mortality rate was less in the surgical group. The total number of skin complication was more in the conservative group.No difference in the incidence of DVT between two groups whereas the PE was in the surgical group. Conclusion: Geriatrics ankle fractures are challenging injury. The surgical management of such injuries showed superior results comparing to conservative management in terms of non-union /mal-union rate and return to pre-injury level with less mortality rate, whereas no difference in complications rate, hospital stay and patient satisfaction.
Distal Fibula Osteotomies Improve Tibiotalar Joint Compression
Authors: Arena Christopher , Aydogan Umur , Roush Evan , Juliano Paul 
Published: September 2018

Category: Basic Sciences/Biologics Introduction/Purpose: Compression is a vital component of achieving a successful ankle arthrodesis. Various modifications of the fibula are used in hopes of achieving higher clinical rates of successful fusion in ankle arthrodesis procedures. We hypothesized that distal fibula osteotomies would improve tibiotalar joint compression under various loading conditions. The purpose of this study was to evaluate the effect of various distal fibula osteotomies on tibiotalar joint compression. Methods: Eight paired adult cadaveric lower extremity specimens with an intact ankle joint and syndesmosis were prepared by exposing and fixating together the proximal tibia and fibula. A jig was constructed to secure the specimen in a vertical position while allowing free axial loading. An anterior surgical approach to the ankle was performed and the joint cartilage denuded. A pressure transducer was used to record baseline ankle pressure distribution. The proximal specimen was loaded with 30, 50, and 100 N static weight and ankle pressure measurements repeated for each load. The fibula was surgically modified with the three procedures: (1) oblique fibular osteotomy 3 cm proximal to the ankle joint; (2) 1 cm long distal fibula resection; (3) complete distal fibula excision. Increasing loads of 30, 50, and 100 N following each surgical procedure were applied and the ankle pressure measurements repeated. Results: Distal fibula resection increased tibiotalar joint force, peak pressure, and contact area compared to intact fibula control for 30, 50, and 100 N loads applied (p<0.05). Compared to intact fibula control, an oblique osteotomy performed and 30 N applied force resulted in a mean ankle joint force increase of 7.5 N (p = 0.007). A 1 cm excisional fibula osteotomy under a 30 N load significantly increased the ankle joint force by 6.6 N (p = 0.015). Complete distal fibula resection under 30 N load significantly increased the ankle joint force compared to control by 13.9 N (p < 0.001). Similar trends were seen for 50 N and 100 N loads with significance reached (*) as represented in Figure 1 (error bar = standard error). Conclusion: A distal fibula oblique osteotomy, 1 cm excisional osteotomy, or complete distal fibula excision may increase the amount of force transmitted to the ankle joint under loading. Our findings suggest complete distal fibular resection results in the highest ankle joint force, contact area, and peak pressure of the surgical options tested. Leaving the fibula intact may decrease tibiotalar compression during ankle arthrodesis. Clinical testing would be important to ultimately test the effects on rates of successful fusion.