Predictors for severe persisting pain in rheumatoid arthritis are associated with pain origin and appraisal of pain.

OBJECTIVES: To determine the proportion of patients with rheumatoid arthritis (RA) with severe persisting pain and to identify predictive factors despite treatment-controlled disease activity. METHODS: This prospective multicentre study included outpatients with RA scheduled for escalation of anti-inflammatory treatment due to active disease and severe pain (Disease Activity Score 28 (DAS28)>3.2 and Visual Analogue Scale (VAS)>50). At week 24, patients were stratified into reference group (DAS28 improvement>1.2 or DAS28≤3.2 and VAS pain score<50), non-responders (DAS28 improvement≤1.2 and DAS28>3.2, regardless of VAS pain score) and persisting pain group (DAS28 improvement>1.2 or DAS28≤3.2 and VAS pain score≥50). The former two subgroups ended the study at week 24. The latter continued until week 48. Demographic data, DAS28-C reactive protein, VAS for pain, painDETECT Questionnaire (PD-Q) to identify neuropathic pain (NeP) and the Pain Catastrophising Scale were assessed and tested for relation to persisting pain. RESULTS: Of 567 patients, 337 (59.4%) were classified as reference group, 102 (18.0%) as non-responders and 128 (22.6%) as patients with persisting pain. 21 (8.8%) responders, 28 (35.0%) non-responders and 27 (26.5%) persisting pain patients tested positive for NeP at week 24. Pain catastrophising (p=0.002) and number of tender joints (p=0.004) were positively associated with persisting pain at week 24. Baseline PD-Q was not related to subsequent persisting pain. CONCLUSIONS: Persisting and non-nociceptive pain occur frequently in RA. Besides the potential involvement of NeP, pain catastrophising and a higher number of tender joints coincide with persisting pain.

The impact of C-reactive protein levels on the effectiveness of upadacitinib in patients with rheumatoid arthritis: a 12-month prospective, non-interventional German study.

OBJECTIVES: We investigated whether the effectiveness of upadacitinib in rheumatoid arthritis (RA) treatment is affected by baseline CRP levels in a real-world setting. METHODS: UPwArds was a prospective, non-interventional study. Patients had moderate-to-severe RA and an inadequate response or intolerance to ≥1 disease-modifying anti-rheumatic drug (DMARD). The primary endpoint was clinical remission (Clinical Disease Activity Index [CDAI] ≤2.8) at 6 months. Secondary endpoints at 12 months included clinical remission and low disease activity assessed by CDAI and Simple Disease Activity Index criteria, DAS28-CRP <2.6/≤3.2, and patient-reported outcomes. The impact of baseline CRP levels (normal vs. above the upper limit of normal [ULN]) on primary and secondary endpoints was evaluated. The effect of concomitant MTX and prior inadequate response to biologic or targeted synthetic DMARDs (b/tsDMARD-IR) on the effectiveness of upadacitinib was also assessed. Safety was evaluated through 12 months. RESULTS: 518 patients were included in the effectiveness analyses. At 6 months, 24.4% of patients achieved the primary endpoint (CDAI ≤2.8). At 12 months, similar proportions of patients with normal CRP and CRP above the ULN at baseline achieved CDAI ≤2.8 (27.3% and 29.1%) and other key secondary endpoints. The effectiveness of upadacitinib was comparable with and without concomitant MTX and in b/tsDMARD-naive and b/tsDMARD-IR patients. The safety results were consistent with the known safety profile of upadacitinib; no new safety signals were identified. CONCLUSIONS: Upadacitinib therapy was effective for RA in a real-world setting. Baseline CRP levels had no significant impact on the effectiveness of upadacitinib.

The association of self-reported symptoms of central sensitization and sleep disturbances in neuropathic pain.

Introduction: Patients with neuropathic pain (NP) report a higher impairment of quality of life and sleep than patients with chronic pain without neuropathic characteristics. These include somatosensory peculiarities like allodynia, a surrogate marker for central sensitization. Objectives: This study aimed to investigate the relation between symptoms of central sensitization and sleep disturbances in patients with NP. Methods: Within this cross-sectional study, data sets of 3339 patients with chronic NP syndromes (painful diabetic polyneuropathy, n = 543; postherpetic neuralgia, n = 1480) or complex regional pain syndromes (CRPS, n = 1316) were analyzed. Neuropathic pain symptoms were assessed with the painDETECT questionnaire (PD-Q), depression with the Patient Health Questionnaire-9, and sleep impairment with items of the Medical Outcomes Study Sleep Scale in 4 subscales. The association of demographic/clinical data, somatosensory phenotype, depression, and pain intensity with sleep impairment was assessed by unadjusted Spearman correlation analyses and multivariable regression analyses. Results: Sleep impairment was observed in all pain aetiologies although with some significant differences in the single sleep items. The intensity of the individual PD-Q items differed to some extent between the 3 pain entities, whereas the PD-Q sum score was similar. Thermal hyperalgesia and burning assessed by the PD-Q were significantly associated with sleep disturbance, adequacy, and quantity but not with sleep somnolence. Only depression and self-reported allodynia had a significant relation to all 4 sleep elements. Conclusion: Beside depression, allodynia as a surrogate marker hints to a possible impact of central sensitization on the sleep disruption of patients with NP.

Global Functioning in Axial Spondyloarthritis is Stronger Associated With Disease Activity and Function Than With Mobility and Radiographic Damage.

OBJECTIVE: The Assessment of Spondyloarthritis International Society Health Index (ASAS HI) is a validated patient-reported outcome (PRO) for global functioning of patients with axial spondyloarthritis (axSpA). The Epionics SPINE (ES) is an electronic device for assessment of axial mobility that provides an objective measure of spinal mobility by assessing range of motion (RoM) and range of kinematics (RoK). The aim of this study is to investigate the relationship between global functioning and clinical measures of disease activity, physical function, spinal mobility, and radiographic damage. METHODS: In a cross-sectional study design, consecutive patients with radiographic and nonradiographic axSpA were included, and the following established tools were assessed: Bath ankylosing spondylitis (AS) disease activity index (BASDAI), Bath AS functional index (BASFI), Bath AS metrology index (BASMI), ASAS HI, and RoM and RoK using ES. Structural damage of spine and sacroiliac joints (SIJ) were assessed by counting the number of syndesmophytes and by New York grading of sacroiliitis. Kendall's tau correlation coefficients were calculated. RESULTS: In 103 patients with axSpA, ASAS HI scores correlated significantly with PRO scores (BASDAI, r = 0.36; BASFI, r = 0.48; and back pain, r = 0.41; all P < 0.001). In contrast, no significant correlation between ASAS HI and RoM and RoK (r between -0.08 and 0.09) and radiographic damage in SIJ and spine (all r between 0.03 and 0.004) were seen, respectively. BASMI scores correlated weakly (r = 0.14; P = 0.05). CONCLUSION: This study shows that axSpA disease-specific PROs have an impact on global functioning, whereas spinal mobility scores, even if objectively assessed by the ES, have limited impact on patient reported-global functioning. The results also suggest that global functioning is, in this cohort, not much dependent on the degree of structural damage in the axial skeleton.

Clinical Relevance of Axial Radiographic Damage in Axial Spondyloarthritis: Evaluation of Functional Consequences by an Objective Electronic Device.

OBJECTIVE: Axial spondyloarthritis (axSpA) is associated with decreased function and mobility of patients as a result of inflammation and radiographic damage. The Epionics SPINE device (ES), an electronic device that objectively measures spinal mobility, including range of motion (RoM) and speed (ie, range of kinematics [RoK]) of movement, has been clinically validated in axSpA. We investigated the performance of the ES relative to radiographic damage in the axial skeleton of patients with axSpA. METHODS: A total of 103 patients with axSpA, 31 with nonradiographic axSpA (nr-axSpA) and 72 with radiographic axSpA (r-axSpA), were consecutively examined. Conventional radiographs of the spine (including presence, number, and location of syndesmophytes) and the sacroiliac joints (SIJs; rated by the modified New York criteria) were analyzed with the ES. Function and mobility were assessed using analyses of covariance and Spearman correlation. RESULTS: The number of syndesmophytes correlated positively with Bath Ankylosing Spondylitis Metrology Index scores (r 0.38, P = 0.02) and correlated negatively with chest expansion (r -0.39, P = 0.02) and ES measurements (-0.53 ≤ r ≤ -0.34, all P < 0.03), except for RoM and RoK regarding rotation and RoK for extension of the lumbar and thoracic spines. In the radiographic evaluation of the SIJs, the extent of damage correlated negatively with ES scores and metric measurements (-0.49 ≤ r ≤ -0.33, all P < 0.001). Patients with r-axSpA, as compared to those with nr-axSpA, showed significantly worse ES scores for RoM, RoK, and chest expansion. CONCLUSION: The ES scores, in accordance with mobility measurements, correlated well with the presence and extent of radiographic damage in the spine and the SIJs. As expected, patients with r-axSpA had more severe impairments than those with nr-axSpA.

Neurological consultations via telemedicine for specialized outpatient palliative care (SOPC) at home and in hospice (TANNE project): study protocol for a randomized controlled trial.

BACKGROUND: Neurological diseases cause numerous challenges in palliative care. Telemedicine may improve the access to specialized expertise in neurology for patients, their relatives, and palliative care physicians. The TANNE study offers teleconsultations by a hospital-based neuropalliative center for specialized outpatient palliative care (SOPC) and hospices. A prospective, partially randomized, controlled trial aims at generating evidence for clinical improvements, quality of life, and cost efficiency. METHODS: SOPC and hospice teams in Bavaria, Germany, are partially randomized to one of two study arms, namely a treatment group with teleconsultations by specialists for neurology and palliative medicine or to a control group with interventions after a 12-months delay. Individual and population-based measures are assessed with a mixed-methods design in order to evaluate the medical effects, the potential for implementation in standard care, and health economic aspects. The primary outcome consists of the mean change difference between groups in the Integrated Palliative Care Outcome Scale (IPOS), which physicians assess before and after treatment of a neurological event. Besides, several secondary outcomes are investigated, including quality of life, which is measured with the revised McGill Quality of Life Questionnaire (McGill QOL-R) as well as items regarding general and health-related quality of life. Further secondary outcomes include the concrete progress of the neurological signs and symptoms; the subjective change in well-being since the start of the treatment of the neurological diseases from the perspectives of patients, their relatives, as well as medical and nursing professionals; as well as patient, professional, and caregiver satisfaction with the teleconsultations. Moreover, a health economic evaluation compares group differences regarding hospital visits and emergency calls with utilization measurements. DISCUSSION: The TANNE trial provides a comprehensive and complex evaluation design for teleconsultations in neuropalliative care. Ethical considerations need to take the patients' vulnerability into account. The project promises to substantially broaden the width of health care services and to improve the quality of life for deserving patients. TRIAL REGISTRATION: German Clinical Trials Register ( www.germanctr.de [July 17, 2022], DRKS ID: DRKS00027436. Registered February 10th, 2022, retrospectively registered. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00027436 [July 17, 2022].

Robot-assisted transthoracic hybrid esophagectomy versus open and laparoscopic hybrid esophagectomy: propensity score matched analysis of short-term outcome.

PURPOSE: Minimally invasive en-bloc esophagectomy is associated with a reduction of postoperative morbidity. This was demonstrated for both total minimally invasive and hybrid esophagectomy. However, little is known about any benefits of robotic assistance compared to the conventional minimally invasive technique, especially in hybrid procedures. METHODS: For this retrospective study, all consecutive patients who had undergone elective esophagectomy with circular stapled intrathoracic anastomosis using the open and the minimally invasive hybrid technique at the University Hospital Magdeburg, from January 2010 to March 2021 were considered for analysis. RESULTS: In total, 137 patients (60.4%) had undergone open esophagectomy. In 45 patients (19.8%), the laparoscopic hybrid technique and in 45 patients (19.8%), the robot-assisted hybrid technique were applied. In propensity score matching analysis comparing the open with the robotic hybrid technique, significant differences were found in favor of the robotic technique (postoperative morbidity, p < 0.01; hospital length of stay, p < 0.01; number of lymph nodes retrieved, p = 0.048). In propensity score matching analysis comparing the laparoscopic with the robotic hybrid technique, a significant reduction of the rate of postoperative delayed gastric emptying (p = 0.02) was found for patients who had undergone robotic esophagectomy. However, the operation time was significantly longer (p < 0.01). CONCLUSIONS: En-bloc esophagectomy using the robotic hybrid technique is associated with a significant reduction of postoperative morbidity and of the hospital length of stay when compared to the open approach. However, when compared to the laparoscopic hybrid technique, only few advantages could be demonstrated.

Inter- and intraobserver reliabilities and critical analysis of the osteoporotic fracture classification of osteoporotic vertebral body fractures.

PURPOSE: The Osteoporotic Fracture Working Group (Spine Division of the German Orthopaedic and Trauma Society) has developed a classification system for osteoporotic thoracolumbar fractures, namely the osteoporotic fracture (OF) classification system. The purpose of this study was to determine the inter- and intraobserver reliabilities of the OF classification system for osteoporotic vertebral body fractures (VFs) at a level-one trauma centre. METHODS: Conventional radiography, magnetic resonance imaging (MRI), and computed tomography (CT) scans of 54 consecutive women who sustained an osteoporotic VF were analysed by six orthopaedic traumatologists with varying levels of experience. The inter- and intraobserver reliabilities of the OF classification system were determined using intraclass correlation coefficients (ICCs) and Cohen's kappa. RESULTS: The overall interobserver reliability of the OF classification system was good (ICC, 0.62 [0.51, 0.72]). The intraobserver reliability was found to be substantial (overall weighted Cohen's kappa estimate [95% confidence interval {CI}] = 0.74 [0.67, 0.80]) and better when the radiography, MRI, and CT scans were assessed together than when only the radiography and MRI scans were evaluated, although the difference was not significant. CONCLUSION: The OF classification system is easy to use. It shows good interobserver reliability and substantial intraobserver reliability if diagnostic prerequisites (conventional radiography, MRI, and CT scans) are met.

Successful Evaluation of Spinal Mobility Measurements With the Epionics SPINE Device in Patients With Axial Spondyloarthritis Compared to Controls.

OBJECTIVE: Epionics SPINE (ES), a novel device that measures spinal movements using electronic sensors including range of motion (RoM) and speed (range of kinematics [RoK]), has already been validated in patients with mechanical back pain and healthy individuals. This study aimed to evaluate ES for quantification of spinal mobility in patients with axial spondyloarthritis (axSpA). METHODS: A total of 153 individuals, 39 female and 114 male, were examined including 134 patients with axSpA, of whom 40 had nonradiographic (nr)-axSpA, 94 had radiographic (r)-axSpA; 19 were healthy controls (HCs). The results were compared using mean ES scores and modeling was performed using multivariable logistic regression models resulting in good validity and high discriminative power. RESULTS: ES measurements showed meaningful differences between patients with axSpA and HCs (all P < 0.001), as well as between r- and nr-axSpA (P < 0.01). In patients with axSpA, a negative correlation between ES and Bath Ankylosing Spondylitis Metrology Index values was found: -0.76 ≤ r ≤ -0.52 (P < 0.05). Bath Ankylosing Spondylitis Functional Index scores showed a similar trend (r > -0.39). Patients with r-axSpA had a more limited and slower spinal mobility than those with nr-axSpA. Other patient-reported outcomes almost did not correlate. CONCLUSION: This study shows that the ES is an objective performance measure and a valid tool to assess spinal mobility in axSpA, also based on the Outcomes Measures in Rheumatology (OMERACT) criteria. RoK and RoM scores provide additional information on physical function of patients with axSpA.

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

Trends in Emergent Groin Hernia Repair-An Analysis From the Herniamed Registry.

Introduction: While the proportion of emergency groin hernia repairs in developed countries is 2.5-7.7%, the percentage in developing countries can be as high as 76.9%. The mortality rate for emergency groin hernia repair in developed countries is 1.7-7.0% and can rise to 6-25% if bowel resection is needed. In this present analysis of data from the Herniamed Registry, patients with emergency admission and operation within 24 h are analyzed. Methods: Between 2010 and 2019 a total of 13,028 patients with emergency admission and groin hernia repairs within 24 h were enrolled in the Herniamed Registry. The outcome results were assigned to the year of repair and summarized as curves. The total patient collective is broken down into the subgroups with pre-operative manual reduction (taxis) of the hernia content, operative reduction of the hernia content without bowel resection and with bowel resection. The explorative Fisher's exact test was used for statistical assessment of significant differences with Bonferroni adjustment for multiple testing. Results: The proportion of emergency admissions with groin hernia repair within 24 h was 2.7%. The percentage of women across the years was consistently 33%. The part of femoral hernias was 16%. The proportion of patients with pre-operative reduction (taxis) remained unchanged at around 21% and the share needing bowel resection was around 10%. The proportion of TAPP repairs rose from 21.9% in 2013 to 38.0% in 2019 (p < 0.001). Between the three groups with pre-operative taxis, without bowel resection and with bowel resection, highly significant differences were identified between the patients with regard to the rates of post-operative complications (4% vs. 6.5% vs. 22.7%; p < 0.0001), complication-related reoperations (1.9% vs. 3.8% vs. 17.7%; p < 0.0001), and mortality rate (0.3% vs. 0.9% vs. 7.5%; p < 0.001). In addition to emergency groin hernia repair subgroups female gender and age ≥66 years are unfavorable influencing factors for perioperative outcomes. Conclusion: For patients with emergency groin hernia repair the need for surgical reduction or bowel resection, female gender and age ≥66 years have a highly significantly unfavorable influence on the perioperative outcomes.

Short-term outcome after robot-assisted hiatal hernia and anti-reflux surgery-is there a benefit for the patient?

PURPOSE: The robotic system was introduced to overcome the technical limitations of conventional laparoscopy. For complex oncological operations, it appears to offer further advantages. With regard to hiatal hernia repair, its role has yet to be determined. METHODS: All consecutive patients who received elective laparoscopic or robot-assisted hiatal hernia repair at a single institution between January 2016 and July 2020 were retrospectively evaluated. We compared both techniques with particular focus on their short-term outcome. A propensity score-matched comparison considering clinical and surgical covariates was also performed between the two groups. RESULTS: 140 patients were included, and 55 (39.3%) underwent a robot-assisted procedure. The baseline demographics and the frequency of previous abdominal operations were comparable for both groups. The size of the hiatal hernia did not differ significantly between the groups (p = 0.06). The mean operative time was significantly longer for the robot-assisted procedure (149 vs. 125 min; p < 0.01) but decreased markedly during the study period. By contrast, no significant differences were observed in terms of conversion rate (p = 1.0) and blood loss (p = 0.25). Likewise, the postoperative morbidity was comparable for both groups (10.9 vs. 12.9; p = 0.79). The hospital length of stay was not significantly different between the laparoscopic and robotic group (4.0 vs. 3.6 days; p = 0.2). After propensity score-matching, 48 patients were identified for each group. Except for the operative time, no other significant differences were found. Thus, the results of the univariate analysis were confirmed. CONCLUSION: Our initial results failed to demonstrate a clear advantage of the robotic technique in patients with refractory gastroesophageal reflux disease and/or symptomatic hiatal hernias.

Surgical Treatment of Talar Neck and Body Fractures: Mid-Term Results of 24 Cases. / Operative Versorgung von zentralen Talusfrakturen: Behandlungsergebnisse von 24 Fällen im mittel- bis langfristigen Verlauf.

BACKGROUND: Talar neck and body fractures are rare. Major posttraumatic complications with a potential reduction in the quality of life are arthrosis and necrosis due to the specific vascular supply. The aim of the study was to evaluate mid-term results of surgery for talar fractures of neck and body. Parameters that potentially affected/influenced treatment outcomes were analysed exploratively. METHODS: 24 patients with 24 talar neck and body fractures (Marti type II n = 9, type III n = 12, type IV n = 3) were retrospectively examined for radiological and clinical functional outcomes. The independent parameters evaluated included age (< 40, ≥ 40 years), sex (male, female), general overall extent of injury (polytrauma/multiple injuries/multiple fractures of the extremities, additional injuries to the same foot, isolated talus fracture), soft tissue damage (open, closed), surgical latency (< 6, ≥ 6 h), fracture classification/displacement (undisplaced [= Marti II], displaced [= Marti III, IV]) and fracture type (talar body, neck fracture). The potential influencing parameters were analysed by univariate analyses. RESULTS: With an average follow-up of 8.7 years (1,25 - 16 years) the AOFAS score was 71.4 ± 22.9 points, the Foot Function Index score 35.9 ± 28.3 points; the physical and mental component summary scores of the Short Form 36, version 2, was 43.8 ± 10.9 and 47.4 ± 13.6 points (mean ± standard deviation), respectively. Thus, the patient reported physical health of the patients was slightly reduced compared to the German population, while the mental health remained largely unaffected. Two patients developed partial avascular necrosis (8%), 10 patients developed osteoarthritis (42%). Of the independent parameters, only the general overall extent of injury showed a significant influence on osteoarthritis (p = 0.002). In the evaluation of undisplaced (n = 9) and displaced (n = 15) fractures, surgical treatment after more than 6 hours did not result in a worse outcome. CONCLUSION: The clinical outcome of internal fixation of talar neck and body fractures can be classified as good. In the study group, there was no correlation between the occurrence of arthrosis and the Marti fracture classification.

What Is the Reality of Hiatal Hernia Management?-A Registry Analysis.

Introduction: To date, the guidelines for surgical repair of hiatal hernias do not contain any clear recommendations on the hiatoplasty technique with regard to the use of a mesh or to the type of fundoplication (Nissen vs. Toupet). This present 10-years analysis of data from the Herniamed Registry aims to investigate these questions. Methods: Data on 17,328 elective hiatal hernia repairs were entered into the Herniamed Registry between 01.01.2010 and 31.12.2019. 96.4% of all repairs were completed by laparoscopic technique. One-year follow-up was available for 11,280 of 13,859 (81.4%) patients operated during the years 2010-2018. The explorative Fisher's exact test was used for statistical calculation of significant differences with an alpha = 5%. Since the annual number of cases in the Herniamed Registry in the years 2010-2012 was still relatively low, to identify significant differences the years 2013 and 2019 were compared. Results: The use of mesh hiatoplasty for axial and recurrent hiatal hernias remained stable over the years from 2013 to 2019 at 20 and 45%, respectively. In the same period the use of mesh hiatoplasty for paraesophageal hiatal hernia slightly, but significantly, increased from 33.0 to 38.9%. The proportion of Nissen and Toupet fundoplications for axial hiatal hernia repair dropped from 90.2% in 2013 to 74.0% in 2019 in favor of "other techniques" at 20.9%. For the paraesophageal hiatal hernias (types II-IV) the proportion of Nissen and Toupet fundoplications was 68.1% in 2013 and 66.0% in 2019. The paraesophageal hiatal hernia repairs included a proportion of gastropexy procedures of 21.7% in 2013 and 18.7% in 2019. The recurrent hiatal hernia repairs also included a proportion of gastropexies 12.8% in 2013 and 15.1% in 2019, Nissen and Toupet fundoplications of 72.7 and 62.7%, respectively, and "other techniques" of 14.5 and 22.2%, respectively. No changes were seen in the postoperative complication and recurrence rates. Conclusion: Clear trends are seen in hiatal hernia repair. The use of meshes has only slightly increased in paraesophageal hiatal hernia repairs. The use of alternative techniques has resulted in a reduction in the use of the "classic" Nissen and Toupet fundoplication surgical techniques.

Quality of electronic treatment records and adherence to prophylaxis in haemophilia and von Willebrand disease: Systematic assessments from an electronic diary.

INTRODUCTION: HaemoassistTM 2 is an electronic system designed for people with bleeding disorders and their physicians to record prophylactic infusions and treatment of bleeds. It aims to improve adherence by permitting reminders and accuracy of documentation by facilitating real-time reporting. AIM: To assess documentation quality and adherence to prophylactic regimens in patients with haemophilia A, haemophilia B or von Willebrand disease who are using HaemoassistTM 2. METHODS: Ten centres enrolled consecutive patients, who had been using HaemoassistTM 2 for ≥ 3 months (Cohort 1, 'quality of documentation'). Of these, patients who had a specified prophylactic regimen in HaemoassistTM 2 for ≥ 3 months were eligible for inclusion in Cohort 2 ('adherence to prophylaxis'). RESULTS: Cohort 1 comprised 796 patients (71% with severe haemophilia A; median 20.5 months of HaemoassistTM 2 use). The most common method of documentation for patients was using the mobile app; the median time between infusion and documentation was 4 hours using the app, compared with 85 hours using a web portal on a stationery device. The median total annualised number of infusions was consistent in the first and last 3 months of documentation (128; IQR: 70-184 and 120; IQR 64-176, respectively). Cohort 2 comprised 202 patients (79% severe haemophilia A; median of 13 months on prophylactic regimen in HaemoassistTM 2). The rate of adherence to prophylaxis was 83%; median deviation between planned and actual infusion time was ± 2 hours. CONCLUSION: HaemoassistTM 2 was used consistently over prolonged periods of time and allowed for precise analysis of adherence to prophylaxis.

Surgical treatment of lateral and posterior process fractures of the talus: Mid-term results of 15 cases after 7 years.

BACKGROUND: We retrospectively evaluated the mid-term results of surgery for talar process fractures (lateral and posterior processes) and exploratively analyzed parameters that potentially impact treatment outcomes. METHODS: Fifteen patients who underwent internal fixation (January 2000 to December 2015) were examined for radiological and clinical functional outcomes. The independent parameters evaluated were age, sex, extent of general injury, soft-tissue damage, surgical latency, and fracture type. RESULTS: All fractures healed completely. Three patients developed osteoarthritis. The American Orthopaedic Foot and Ankle Society Ankle/Hindfoot Scale score was 79.5±18.6, the Functional Foot Index score was 31.1±31.4, and the physical and mental component summary scores of the Short Form 36, version 2, were 46.6±11.8 and 50.3±9.1, respectively. No influence on the above scores was determined. CONCLUSIONS: The clinical outcomes of internal fixation of talar process fractures were good. Delayed surgical treatment (≥14days) did not significantly lead to poorer outcomes in our patients.

Smaller Inguinal Hernias are Independent Risk Factors for Developing Chronic Postoperative Inguinal Pain (CPIP): A Registry-based Multivariable Analysis of 57, 999 Patients.

OBJECTIVE: Impact of inguinal hernia defect size as stratified by the European Hernia Society (EHS) classification I to III on the rate of chronic postoperative inguinal pain (CPIP). BACKGROUND: CPIP is the most important complication after inguinal hernia repair. The impact of hernia defect size according to the EHS classification on CPIP is unknown. METHODS: In total, 57,999 male patients from the Herniamed registry undergoing primary unilateral inguinal hernia repair including a 1-year follow-up were selected between September 1, 2009 and November 30, 2016. Using multivariable analysis, the impact of EHS inguinal hernia classification (EHS I vs EHS II vs EHS III and/or scrotal) on developing CPIP was investigated. RESULTS: Multivariable analysis revealed for smaller inguinal hernias a significant higher rate of pain at rest [EHS I vs EHS II: odds ratio, OR = 1.350 (1.180-1.543), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 1.839 (1.504-2.249), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.363 (1.125-1.650), P = 0.002], pain on exertion [EHS I vs EHS II: OR = 1.342 (1.223-1.473), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 2.002 (1.727-2.321), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.492 (1.296; 1.717), P < 0.001], and pain requiring treatment [EHS I vs EHS II: OR = 1.594 (1.357-1.874), P < 0.001; EHS I vs EHS III and/or scrotal: OR = 2.254 (1.774-2.865), P < 0.001; EHS II vs EHS III and/or scrotal: OR = 1.414 (1.121-1.783), P = 0.003] at 1-year follow-up. Younger patients (<55 y) revealed higher rates of pain at rest, pain on exertion, and pain requiring treatment (each P < 0.001) with a significantly trend toward higher rates of pain in smaller hernias. CONCLUSIONS: Smaller inguinal hernias have been identified as an independent patient-related risk factor for developing CPIP.

An investigation of factors associated with the development of postoperative bone flap infection following decompressive craniectomy and subsequent cranioplasty.

OBJECTIVE: After a decompressive craniectomy (DC), a cranioplasty (CP) is often performed in order to improve neurosurgical outcome and cerebral blood circulation. But even though the performance of a CP subsequent to a DC has become routine medical practice, patients can in fact develop many complications from the surgery that could prolong hospitalization and lead to unfavorable prognoses. This study investigates one of the most frequent complications, bone flap infection, in order to identify prognostic factors of its development. PATIENTS AND METHODS: In this single-center study, we have retrospectively examined 329 CPs performed between 2002 and 2017. Multiple categorical and metric parameters (e.g., timing of CP, bone flap material, specific laboratory signs of infection and reason for DC) were analyzed applying unadjusted and multivariable testing. RESULTS: Bone flap infection occurred in 24 patients (7.3%). A CP performed more than six months after a DC is associated with a significantly increased risk of infection (OR = 0.308 [0.118; 0.803], p = 0.016). However, with CPs performed after twelve months, the incidence decreases, but without provable statistical impact. In addition, bone flap infection is strongly related to the neurological outcome and the material used for the skull implant, with the use of synthetic bone flaps leading to a marked increase in the rate of infection (p < 0.001). CONCLUSIONS: This study supports the hypothesis that the risk of infection is higher the longer the elapsed time between DC and CP, especially if more than six months. Based on our results, the best DC-CP time frame for keeping the infection rate low is performing the CP within the first six months after the DC. In the event that the CP cannot be performed within the first six months, a CP performed twelve months or more after the DC seems to have a favorable outcome as well.