Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

[Medial foot and ankle instability]. / Mediale Fuß- und Sprunggelenkinstabilitäten.

The deltoid or medial collateral ligament consisting of superficial and deep components together with the spring ligament is the primary stabilizer of the ankle joint. Injuries of these anatomical structures are more frequent than assumed but are nevertheless often overlooked. Inadequate treatment can lead to chronic pain, instability, hindfoot deformities and ankle arthritis. Patient history and clinical assessment can help to identify injuries of the deltoid ligament. Magnetic resonance imaging (MRI) is the diagnostic method of choice. Arthroscopy of the ankle joint can be a valuable tool in the assessment of the injury. Treatment should include accompanying injuries and deformities and can range from immobilization in a cast to ligament repair up to ligament reconstruction using a free tendon graft.

Fixation performance of an ultrasonically fused, bioresorbable osteosynthesis implant: A biomechanical and biocompatibility study.

Bioresorbable implants may serve as an alternative option for the fixation of bone fractures. Because of their minor inherent mechanical properties and insufficient anchorage within bone bioresorbable implants have so far been limited to mechanically nondemanding fracture types. By briefly liquefying the surface of the biomaterial during insertion, bioresorbable implants can be ultrasonically fused with bone to improve their mechanical fixation. The objective of this study was to investigate the biomechanical fixation performance and in vivo biocompatibility of an ultrasonically fused bioresorbable polymeric pin (SonicPin). First, we biomechanically compared the fused pin with press fitted metallic and bioresorbable polymeric implants for quasi-static and fatigue strength under shear and tensile loading in a polyurethane foam model. Second, fused implants were inserted into cancellous bovine bone and tested biomechanically to verify the reproducibility of their fusion behavior. Finally, the fused pins were tested in a lapine model of femoral condyle osteotomies and were histologically examined by light and transmission electron microscopy. While comparable under static shear loads, fixation performance of ultrasonically fused pins was significantly (p = 0.001) stronger under tensile loading than press fit implants and showed no pull-out. Both bioresorbable implants withstood comparable fatigue shear strength, but less than the K-wire. In bovine bone the ultrasonic fusion process worked highly reproducible and provided consistent mechanical fixation. In vivo, the polymeric pin produced no notable foreign body reactions or resorption layers. Ultrasonic fusion of polymeric pins achieved adequate and consistent mechanical fixation with high reproducibility and exhibits good short-term resorption and biocompatibility.

Sudanese community pharmacy practice and its readiness for change to patient care.

OBJECTIVES: This study aims to describe the current state of Sudanese community pharmacy practice and explore the capacity of existing community pharmacies to foster the change to pharmaceutical care (PC) and to assess attitude and knowledge of community pharmacists regarding PC and identify barriers. METHODS: A structured, self-administered, piloted questionnaire was distributed to the pharmacists in charge of 274, randomly selected, community pharmacies in Khartoum state. The questionnaire included six domains: demographic characteristics, organizational structure of community pharmacies, current activities of community pharmacists, their attitudes and knowledge regarding PC, and potential barriers. Attitude responses were measured by a 5-point Likert scale. KEY FINDINGS: Response rate was 67%. Community pharmacies are short on some tools that are deemed necessary for PC implementation, e.g. consultation areas. Community pharmacists provide mainly product-focused services with no or little PC activities. However, there is a highly positive attitude among the majority of respondents towards practice change to include PC (mean positive score ± standard deviation = 4.39 ± 0.73, frequency (%) = 89%). Many barriers to implementation of PC were identified, e.g. pharmacists' clinical knowledge and lack of understanding of pharmacist's new role. CONCLUSION: Sudanese community pharmacists favour practice change to include PC. Successful implementation of PC requires substantial organizational and structural changes in community pharmacies, including provision of clinical knowledge, strengthening of clinical training and new practice standards. This change in practice could benefit from involvement of academia, governmental bodies and professional organizations working together for the pharmacy profession.

The role of Sudanese community pharmacists in patients' self-care.

OBJECTIVES: To describe the current and potential roles of Sudanese community pharmacists in responding to symptoms (RTS) and chronic diseases management (CDM) and identify perceived barriers. SETTINGS: Community pharmacies in Khartoum State. METHOD: A structured, self-administered, piloted questionnaire was conducted of pharmacists in charge of 274, randomly selected, community pharmacies. Close ended questions and a 5-point Likert-type scale were used to measure responses. MAIN OUTCOME MEASURE: Respondents' demographics, their current activities, attitude and involvement in RTS and CDM and potential barriers. Response rate was 67 %. The majority of respondents (>90 %) reported that they are involved in RTS activities but have negative views regarding practice standards. They lack specific lists of minor conditions and their treatment (87.4 %), recorded counseling procedure (84.7 %), and referral forms (85.8 %). Almost all community pharmacists see an important role for them in CDM (4.54 ± 0.74, 95.3 %) and accept team work with other health care providers (4.46 ± 0.74, 87.5 %). Lack of proper knowledge and training, time, space, patients' acceptance and official recognition of pharmacists' new role, were some of the identified barriers. CONCLUSION: Sudanese community pharmacists provide RTS and CDM services; however, clinical knowledge and training and well defined national practice standards needs were identified. The current product-focused activities need to be refined to include more patient-focused services. For Improved patients' self-care services, a number of obstacles identified by surveyed pharmacists need to resolved. This requires collaboration of different parties including academics, governmental bodies and professional organizations.

[Hindfoot arthrodesis for post-infectious ankle destruction using an intramedullary retrograde hindfoot nail]. / Die Rückfußarthrodese bei postinfektiöser Sprunggelenkdestruktion mit einem intramedullären retrograden Arthrodesennagel.

BACKGROUND: Limb salvage after operations with deep infections of the ankle is often successful using arthrodesis of the hindfoot. The aim of this study was to evaluate the results of arthrodesis using a retrograde intramedullary nail following post-infectious ankle destruction. PATIENTS AND METHODS: Between 2007 and 2010 a total of 44 patients were treated with tibiotalocalcaneal (TTC) arthrodesis and 14 patients with tibiocalcaneal (TC) arthrodesis using a retrograde hindfoot nail after quieting of infection. Evaluation included the American Orthopaedic Foot and Ankle Society (AOFAS) and the short-form 12-item (SF-12) scores. RESULTS: Of the 58 patients 49 (35 male and 14 female) could be followed-up. The average time of follow-up was 18 months and the mean age was 58 years. In 85.7 % bony union could be achieved and 10.2 % suffered from reinfections. The mean results achieved in the different scores were AOFAS 56 and SF-12 39.1 (physical health summary scale) and 46.1 (mental health summary scale). Statistical analysis showed a significantly higher rate of bony fusion for TTC arthrodesis. Bony non-union showed a significant correlation to patients with reinfection and to diabetic patients. CONCLUSIONS: Hindfoot arthrodesis for treatment of septic arthritis after infections is possible by using an intramedullary nail. The results show a high rate of fusion with an acceptable reinfection rate and good patient acceptance.

Involvement of Sudanese community pharmacists in public health activities.

OBJECTIVES: To evaluate attitude of community pharmacists towards health education, promotion and screening, assess the extent of their actual involvement in such activities and identify barriers for their provision. SETTINGS: Community pharmacies in Khartoum State. METHOD: A structured, self-administered, piloted questionnaire was distributed to the pharmacists in charge of 274, randomly selected, community pharmacies. The questionnaire was divided into 5 domains; demographic characteristics, attitude, involvement, screening and barriers. Attitude responses were measured by a 5-point Likert-type scale. Descriptive statistical analysis was used. MAIN OUTCOME MEASURES: willingness of community pharmacist to participate in public health activities, their current involvement and the barriers they encounter. RESULTS: Response rate was 67%. The majority of community pharmacists (>70%) is willing to take part in public health services and consented to be trained on behavioral modification for provision of more effective health education and promotion services to the public. Currently a high proportion of community pharmacists are providing health information on healthy diet (4.38 ± 0.76, 89.1%), obesity and weight reduction (4.15 ± 0.78, 78.1%), exercise (3.93 ± 0.83, 76.6%), smoking cessation (4.15 ± 1.01, 76.1%) and contraception methods and medicines (3.98 ± 0.95, 73.4%). However, their involvement is achieved through the process of traditional advising during prescription filling. Blood pressure measurement (89.1%) and blood glucose testing (85.9%) were highly ranked by community pharmacists as acceptable and can be easily handled. Lack of time, training, official recognition for pharmacists' health promotion activities, the concept of team work with other health care professionals topped the barriers. CONCLUSION: The surveyed community pharmacists favor the provision of public health activities following appropriate training and reduction or removal of barriers. Further interventional studies regarding application of a health education and health promotion model to selected populations in community pharmacies are recommended.

Calcifying pseudoneoplasms of the neuraxis (CAPNON): clinical features and therapeutic options.

INTRODUCTION: Calcifying pseudoneoplasms of the neuraxis (CAPNON) are rare, slow-growing lesions occurring anywhere in the central nervous system (CNS). Since their first description in 1978, only 39 cases have been reported in the literature. METHODS: The cases of two patients with histopathologically verified diagnoses of CAPNON are presented. Thereafter, we review all reports published so far with respect to study type, number of patients, anatomical area (intracranial, spinal, or both), clinical presentation, radiological presentation, therapy, duration of follow-up, incidence and type of complication, and outcome. Furthermore, current recommendations for the management of spinal and cerebral CAPNON are discussed. RESULTS: A total of 19 retrospective articles were identified and selected for review: 6 case series (31.6 %) and 13 reports of single cases (68.4 %). The 19 articles and our two additional cases added up to a total of 19 patients with spinal CAPNON and 22 patients with intracranial CAPNON. All patients were treated surgically. A follow-up was provided in 13 patients with spinal (68.4 %) and in 16 patients with intracranial CAPNON (72.7 %), respectively. The follow-up showed no signs of recurrence in 12 of 13 patients with spinal CAPNON (92.3 %) and in 15 of 16 patients with intracranial CAPNON (93.7 %). One-tailed Fisher's exact test revealed no significant difference between complete and incomplete resection in terms of disease recurrence (spinal: p = 0.6842; intracranial: p = 0.3749). Analysis of the literature did not reveal any deaths directly associated with CAPNON. CONCLUSIONS: Calcifying pseudoneoplasms are rare benign lesions of the CNS of yet unknown origin. Because of the increasing number of reports, this clinical entity should be taken into consideration in the differential diagnosis of intracranial and intraspinal calcified lesions.

Meningioangiomatosis in a patient with progressive focal neurological deficit-case report and review of literature.

Meningioangiomatosis (MA) represents a vascular hamartoma accompanied by meningothelial cell proliferation. It generally becomes symptomatic with difficult to control seizures, though in some patients it may be asymptomatic. We present the case of a 41-year-old male patient with a newly developed central distal monoparesis of the left leg. Cranial magnetic resonance imaging (MRI) and further diagnostic characterization via (18)F-Fluoro-Ethyl-Tyrosine positron emission tomography ((18)F-FET-PET) indicated a low-grade glioma. Histopathological diagnosis revealed a meningioangiomatosis. The clinical, radiological and neuropathological findings of this rare constellation are described and discussed with the actual literature.

[Deep infection after treatment of proximal femur fractures--results and assessment of life quality]. / Die tiefe Infektion nach osteosynthetischer Versorgung hüftgelenknaher Femurfrakturen - Behandlungsergebnisse und Lebensqualität.

BACKGROUND: Proximal femur fractures are the second most prevalent fractures in patients older than 65 years. Despite large improvements in implant design and surgical technique, complications in fracture healing are very common. Deep infection after osteosynthetic treatment is considered to be one of the major complications with a high rate of mortality. Little is known about the adequate treatment and results in patients with infection of proximal femur fractures. The aim of this study was to evaluate the different treatment options for eradication of infection as well as to analyse the clinical outcome and quality of life. PATIENTS AND METHODS: 40 patients treated for infected proximal femur fractures between 2001 and 2010 were retrospectively analysed. Quality of life was assessed in 21 patients after an average of 40 months using the WOMAC and the SF-12 score. RESULTS: Surgical treatment included complete removal of infected implants and radical debridement. In 20 patients resection arthroplasty had to be performed. Ten patients were treated with a modular prosthesis, 4 patients were treated with a proximal femur replacement. Due to severe infection and risk-increasing comorbidities, resection arthroplasty had to be performed in the remaining 12 patients. Re-osteosynthesis could be performed in 13 patients. Average time of treatment was 67 days. At the time of follow-up the rate of mortality proved to be 15%. The rate of reinfection was 14.6%. At the time of follow-up infection was still prevalent in 2 patients. Dislocation after the hip prosthesis occurred in 3 of 14 patients. Of the 13 patients who received re-osteosynthesis one patient suffered a reinfection. Delayed fracture healing was treated with spongiosa grafts in 2 cases. 33% of the patients with resection arthroplasty died during follow-up. Statistical analysis showed better results in WOMAC and SF-12 scores in patients with hip prosthesis. Patients with re-osteosynthesis showed a larger variation in results. CONCLUSION: Deep infection after osteosynthetic treatment of proximal femur fractures is a severe complication. Radical surgical treatment and adequate local and systemic antibiotic application can help clear an infection. Quality of life is significantly reduced. Treatment should therefore be adapted to the individual patient's condition.

[Cerebral arteriovenous malformations: clinical aspects and treatment possibilities]. / Zerebrale arteriovenöse Malformationen: Klinische Aspekte und Therapieoptionen.

Cerebral arteriovenous malformations (AVM) are vascular lesions that occur either congenitally or arise in early childhood. AVM are characterised by arteriovenous shunts through a nidus of coiled and tortuous vascular connections that connect feeding arteries to draining veins. Generally, AVM become evident through intracranial haemorrhage in patients aged 20-40 years. Especially, in the young adult presenting with epileptic seizures or focal neurological deficits AVM needs to be considered as an important differential diagnosis. Treatment modalities for the occlusion of symptomatic AVM include microneurosurgery, endovascular embolisation, or radiosurgery. These can be performed each on its own or in combination with the others. Incidentally diagnosed AVM require a thorough and individual consideration of treatment indications. This review deals with the current recommendations for the treatment of AVM in the adult patient.