Psychological, social and biological correlates of body perception disturbance in complex regional pain syndrome

Body Perception Disturbance (BPD) in Complex Regional Pain Syndrome (CRPS) still represents a poorly understood phenomenon. Research has shown that knowledge about changes in body perception can yield relevant information for understanding and treating the disease. This study addressed possible connections between BPD and psychological and social factors, pain intensity, and disease duration. Sixty patients with chronic CRPS Type I of the hand were recruited. Body Perception Disturbance was assessed using the Galer and Jensen Neurobehavioral Questionnaire (GJ) and the BATH CRPS Body Perception Disturbance Scale (BATH). Depression, anxiety, stress, childhood trauma and other life events were assessed using standardized and validated questionnaires. This study found that BPD in CRPS was significantly correlated with measures of depression, anxiety, current stress, quality of life, and pain intensity, but not with stress experienced in the twelve months preceding onset of illness, childhood trauma, or duration of illness. Future research needs to identify which patients are most likely to develop these psychological conditions of CRPS, so that early, preventive intervention is possible. This study establishes a relationship between depression, anxiety, current stress, quality of life, pain intensity, and BPD severity. It also supports literature suggesting that preexisting stress, childhood trauma, and disease duration have no influence on BPD. The findings suggest that there is a bidirectional influence between brain alterations, psychological symptoms, and illness severity

The T-pod is as stable as supraacetabular fixation using 1 or 2 Schanz screws in partially unstable pelvic fractures: a biomechanical study

Introduction: Unstable fractures of the pelvis remain the predominant cause of severe hemorrhage, shock and early death in severely injured patients. The use of pelvic binders has become increasingly popular, particularly in the preclinical setting. There is currently insufficient evidence available about the stability of the pelvic binder versus supraacetabular fixation using 1 or 2 Schanz screws. We aimed to analyze the stability of the pelvic binder and supraacetabular fixateurs using either 1 or 2 Schanz screws in a cadaver model of an induced pelvic B-type fracture. Materials and methods: The study was undertaken in 7 human fresh-frozen cadaveric pelvises with induced AO-type B fractures. Three stabilization techniques were compared: T-POD (pelvic bandage), supraacetabular external fixator with 1 pin on each side and external fixator with 2 pins on each side. Stability and stiffness were analyzed in a biomechanical testing machine using a 5-step protocol with static and dynamic loading, dislocation data were retrieved by ultrasound sensors at the fracture sites. Results: No significant differences in fracture fragment displacement were detected when using either the T-POD, a 1-pin external fixator or a 2-pin external fixator (P > 0.05). The average difference in displacement between the three methods was < 1 mm. Conclusions: Pelvic binders are suitable for reduction of pelvic B-type fractures. They provide stability comparable to that of supraacetabular fixators, independently of whether 1 or 2 Schanz screws per side are used. Pelvic binders provide sufficient biomechanical stability for transferring patients without the need to first replace them with surgically applied external fixators. However, soft tissue irritation has to be taken into consideration and prolonged wear should be avoided. Level of evidence: Level III

Toward a Regulatory Pathway for the Use of in Silico Trials in The Ce Marking of Medical Devices

In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing

Modified less invasive anterior subcutaneous fixator for unstable Tile-C-pelvic ring fractures

Background Operative procedures for unstable pelvic ring fractures remain controversially discussed. Minimally invasive treatment options for pelvic ring fractures have several benefits for the patient. But they can also provide disadvantages. Anterior subcutaneous pelvic fixation (INFIX) has shown promising biomechanical results in pelvic ring fractures, but there is a high complication rate of nerve injuries. An additional screw to the INFIX seems to be more stable. The aim of this study is to compare biomechanical stability of a new modified unilateral INFIX fixing the unilateral injured pelvic ring with the standard INFIX. Methods 24 composite synthetic full pelvises were used in this study. 4 groups each with a number of six pelvic specimens were randomly assigned. A C1.3-type pelvic fracture was made with an osteotomy of the sacrum and an osteotomy of the anterior pelvic ring. Fracture fixation was performed within the four groups: (1) unilateral INFIX, (2) “extended” unilateral INFIX + additional pubic ramus pedicle screw, (3) bilateral INFIX, (4) “extended” bilateral INFIX + additional pubic ramus pedicle screw. All specimens were cyclic loaded with 200 N until maximum of 300 N. Distance/dislocation of the fracture fragments were detected with 3D-ultrasound measuring system. Stiffness was calculated. Results Extended unilateral INFIX showed the lowest mean dislocation. Lowest rotational stability was displayed by the standard bilateral INFIX. A significant difference (P = 0.04) was shown between the extended unilateral INFIX and the “standard” bilateral INFIX in terms of rotational stability. Extended unilateral INFIX showed significantly improved stability of anterior fracture dislocation (P = 0.01) and unilateral INFIX showed the highest rotational stiffness. Anterior fixation stiffness of the unilateral INFIX was significantly improved using an additional symphysis/pubic ramus screw (P = 0.002). Conclusion Extended unilateral INFIX (+ additional pubic ramus pedicle screw) is a feasible minimally invasive treatment for anterior pelvic ring fractures. Higher stability and lower probability of bilateral nerve damage is provided by the extended unilateral INFIX compared to the standard bilateral INFIX