Comparative effectiveness research across two spine registries

Background: Comparative effectiveness research in spine surgery is still a rarity. In this study, pain alleviation and quality of life (QoL) improvement after lumbar total disc arthroplasty (TDA) and anterior lumbar interbody fusion (ALIF) were anonymously compared by surgeon and implant. Methods: A total of 534 monosegmental TDAs from the SWISSspine registry were analyzed. Mean age was 42years (19-65years), 59 % were females. Fifty cases with ALIF were documented in the international Spine Tango registry and used as concurrent comparator group for the pain analysis. Mean age was 46years (21-69years), 78 % were females. The average follow-up time in both samples was 1year. Comparison of back/leg pain alleviation and QoL improvement was performed. Unadjusted and adjusted probabilities for achievement of minimum clinically relevant improvements of 18 VAS points or 0.25 EQ-5D points were calculated for each surgeon. Results: Mean preoperative back pain decreased from 69 to 30 points at 1year (ØΔ 39pts) after TDA, and from 66 to 27 points after ALIF (ØΔ 39pts). Mean preoperative QoL improved from 0.34 to 0.74 points at 1year (ØΔ 0.40pts). There were surgeons with better patient selection, indicated by lower adjusted probabilities reflecting worsening of outcomes if they had treated an average patient sample. ALIF had similar pain alleviation than TDA. Conclusions: Pain alleviation after TDA and ALIF was similar. Differences in surgeon's patient selection based on pain and QoL were revealed. Some surgeons seem to miss the full therapeutic potential of TDA by selecting patients with lower symptom severit

Radiographic and safety details of vertebral body stenting : results from a multicenter chart review

Background: Up to one third of BKP treated cases shows no appreciable height restoration due to loss of both restored height and kyphotic realignment after balloon deflation. This shortcoming has called for an improved method that maintains the height and realignment reached by the fully inflated balloon until stabilization of the vertebral body by PMMA-based cementation. Restoration of the physiological vertebral body height for pain relief and for preventing further fractures of adjacent and distant vertebral bodies must be the main aim for such a method. A new vertebral body stenting system (VBS) stabilizes the vertebral body after balloon deflation until cementation. The radiographic and safety results of the first 100 cases where VBS was applied are presented. Methods: During the planning phase of an ongoing international multicenter RCT, radiographic, procedural and followup details were retrospectively transcribed from charts and xrays for developing and testing the case report forms. Radiographs were centrally assessed at the institution of the first/senior author. Results: 100 patients (62 with osteoporosis) with a total of 103 fractured vertebral bodies were treated with the VBS system. 49 were females with a mean age of 73.2 years; males were 66.7 years old. The mean preoperative anterior-middle-posterior heights were 20.3-17.6-28.0 mm, respectively. The mean local kyphotic angle was 13.1°. The mean preoperative Beck Index (anterior edge height/posterior edge height) was 0.73, the mean alternative Beck Index (middle height/posterior edge height) was 0.63. The mean postoperative heights were restored to 24.5-24.6-30.4 mm, respectively. The mean local kyphotic angle was reduced to 8.9°. The mean postoperative Beck Index was 0.81, the mean alternative one was 0.82. The overall extrusion rate was 29.1%, the symptomatic one was 1%. In the osteoporosis subgroup there were 23.8% extrusions. Within the three months followup interval there were 9% of adjacent and 4% of remote new fractures, all in the osteoporotic group. Conclusions: VBS showed its strengths especially in realignment of crush and biconcave fractures. Given that fracture mobility is present, the realignment potential is sound and increases with the severity of preoperative vertebral body deformation

Safety, effectiveness and predictors for early reoperation in therapeutic and prophylactic vertebroplasty: short-term results of a prospective case series of patients with osteoporotic vertebral fractures

Introduction: Vertebroplasty (VP) is a cost-efficient alternative to kyphoplasty; however, regarding safety and vertebral body (VB) height restoration, it is considered inferior. We assessed the safety and efficacy of VP in alleviating pain, improving quality of life (QoL) and restoring alignment. Methods: In a prospective monocenter case series from May 2007 until July 2008, there were 1,408 vertebroplasties performed during 319 interventions in 306 patients with traumatic, lytic and osteoporotic fractures. The 249 interventions in 233 patients performed because of osteoporotic vertebral fractures were analyzed regarding demographics, treatment and radiographic details, pain alleviation (VAS), QoL improvement (NASS and EQ-5D), complications and predictors for new fractures requiring a reoperation. Results: The osteoporotic patient sample consisted of 76.7% (179) females with a median age of 80years. A total of 54 males had a median age of 77years. On average, there were 1.8 VBs fractured and 5 VBs treated. The preoperative pain was assessed by the visual analog scale (VAS) and decreased from 54.9 to 40.4 pts after 2months and 31.2 pts after 6months. Accordingly, the QoL on the EQ-5D measure (−0.6 to 1) improved from 0.35 pts before surgery to 0.56 pts after 2 and to 0.68 pts after 6months. The preoperative Beck Index (anterior height/posterior height) improved from a mean of 0.64 preoperative to 0.76 postoperative, remained stable at 2months and slightly deteriorated to 0.72 at 6months postoperatively. There were cement leakages in 26% of the fractured VBs and in 1.4% of the prophylactically cemented VBs; there were symptoms in 4.3%, and most of them were temporary hypotension and one pulmonary cement embolism that remained asymptomatic. The univariate regression model revealed a tendency for a reduced risk for new or refractures on radiographs (OR=2.61, 95% CI 0.92-7.38, p=0.12) and reoperations (OR=2.9, 95% CI 0.94-8.949, p=0.1) when prophylactic augmentation was performed. The final multivariate regression model revealed male patients to have an about three times higher refracture risk (radiographic) (OR=2.78, p=0.02) at 6months after surgery. Patients with a lumbar index fracture had an about three to five times higher refracture/reoperation risk than patients with a thoracic (OR=0.33/0.35, p=0.009/0.01) or thoracolumbar (OR=0.32/0.22, p=0.099/0.01) index fracture. Conclusion: If routinely used, VP is a safe and efficacious treatment option for osteoporotic vertebral fractures with regard to pain relief and improvement of the QoL. Even segmental realignment can be partially achieved with proper patient positioning. Certain patient or fracture characteristics increase the risk for early radiographic refractures or new fractures, or a reoperation; a consequent prophylactic augmentation showed protective tendencies, but the study was underpowered for a final conclusio

The International Documentation and Evaluation System IDES: a single center observational case series for development of an ankle prosthesis documentation questionnaire and study of its feasibility and face validity

ABSTRACT: BACKGROUND: The number of implanted total ankle replacements is increasing and most articles present short- and mid-term results. Comparison of outcomes is difficult because of inconsistent terminology and different use of parameters. MATERIALS AND METHODS: We created a module for total ankle prostheses in the framework of the International Documentation and Evaluation System (IDES). Content development was conducted with an iterative process based on a single surgeon series of 74 HINTEGRA(c) total ankle replacements and expert opinions. RESULTS: The IDES ankle module comprises three forms A, B and C for recording of primary (A), revision (B) and followup (C) procedures. 74 primary interventions, 28 revisions and 92 followups could be documented in detail with the final version of the questionnaires. CONCLUSION: The IDES-forms facilitate a structured and standardized data collection for total ankle arthroplasties. Implemented on the academic MEMdoc portal http://www.memdoc.org of the University of Bern, all registered users can make use of IDES in its online or paper based versions

Development and validation of a quantitative method to assess pedicle screw loosening in posterior spine instrumentation on plain radiographs

Purpose: Currently, the diagnosis of pedicle screw (PS) loosening is based on a subjectively assessed halo sign, that is, a radiolucent line around the implant wider than 1mm in plain radiographs. We aimed at development and validation of a quantitative method to diagnose PS loosening on radiographs. Methods: Between 11/2004 and 1/2010 36 consecutive patients treated with thoraco-lumbar spine fusion with PS instrumentation without PS loosening were compared with 37 other patients who developed a clinically manifesting PS loosening. Three different angles were measured and compared regarding their capability to discriminate the loosened PS over the postoperative course. The inter-observer invariance was tested and a receiver operating characteristics curve analysis was performed. Results: The angle measured between the PS axis and the cranial endplate was significantly different between the early and all later postoperative images. The Spearman correlation coefficient for the measurements of two observers at each postoperative time point ranged between 0.89 at 2weeks to 0.94 at 2months and 1year postoperative. The angle change of 1.9° between immediate postoperative and 6-month postoperative was 75% sensitive and 89% specific for the identification of loosened screws (AUC=0.82). Discussion: The angle between the PS axis and the cranial endplate showed good ability to change in PS loosening. A change of this angle of at least 2° had a relatively high sensitivity and specificity to diagnose screw loosening

Comparative effectiveness research across two spine registries

Comparative effectiveness research in spine surgery is still a rarity. In this study, pain alleviation and quality of life (QoL) improvement after lumbar total disc arthroplasty (TDA) and anterior lumbar interbody fusion (ALIF) were anonymously compared by surgeon and implant

Tuberculosis diagnostics and biomarkers: needs, challenges, recent advances, and opportunities

Tuberculosis is unique among the major infectious diseases in that it lacks accurate rapid point-of-care diagnostic tests. Failure to control the spread of tuberculosis is largely due to our inability to detect and treat all infectious cases of pulmonary tuberculosis in a timely fashion, allowing continued Mycobacterium tuberculosis transmission within communities. Currently recommended gold-standard diagnostic tests for tuberculosis are laboratory based, and multiple investigations may be necessary over a period of weeks or months before a diagnosis is made. Several new diagnostic tests have recently become available for detecting active tuberculosis disease, screening for latent M. tuberculosis infection, and identifying drug-resistant strains of M. tuberculosis. However, progress toward a robust point-of-care test has been limited, and novel biomarker discovery remains challenging. In the absence of effective prevention strategies, high rates of early case detection and subsequent cure are required for global tuberculosis control. Early case detection is dependent on test accuracy, accessibility, cost, and complexity, but also depends on the political will and funder investment to deliver optimal, sustainable care to those worst affected by the tuberculosis and human immunodeficiency virus epidemics. This review highlights unanswered questions, challenges, recent advances, unresolved operational and technical issues, needs, and opportunities related to tuberculosis diagnostics

Quantum quenches in the anisotropic spin-1/2 Heisenberg chain: different approaches to many-body dynamics far from equilibrium

Recent experimental achievements in controlling ultracold gases in optical lattices open a new perspective on quantum many-body physics. In these experimental setups it is possible to study coherent time evolution of isolated quantum systems. These dynamics reveal new physics beyond the low-energy properties usually relevant in solid-state many-body systems. In this paper we study the time evolution of antiferromagnetic order in the Heisenberg chain after a sudden change of the anisotropy parameter, using various numerical and analytical methods. As a generic result we find that the order parameter, which can show oscillatory or non-oscillatory dynamics, decays exponentially except for the effectively non-interacting case of the XX limit. For weakly ordered initial states we also find evidence for an algebraic correction to the exponential law. The study is based on numerical simulations using a numerical matrix product method for infinite system sizes (iMPS), for which we provide a detailed description and an error analysis. Additionally, we investigate in detail the exactly solvable XX limit. These results are compared to approximative analytical approaches including an effective description by the XZ-model as well as by mean-field, Luttinger-liquid and sine-Gordon theories. This reveals which aspects of non-equilibrium dynamics can as in equilibrium be described by low-energy theories and which are the novel phenomena specific to quantum quench dynamics. The relevance of the energetically high part of the spectrum is illustrated by means of a full numerical diagonalization of the Hamiltonian.Comment: 28 page

14th St. Gallen International Breast Cancer Conference 2015: Evidence, Controversies, Consensus - Primary Therapy of Early Breast Cancer: Opinions Expressed by German Experts

The key topics of this year's 14th St. Gallen Consensus Conference on the diagnosis and therapy of primary breast cancer were again questions about breast surgery and axillary surgery, radio-oncology and systemic therapy options in consideration of tumor biology, and the clinical application of multigene assays. This year, the consensus conference took place in Vienna. From a German perspective, it makes sense to substantiate the results of the vote of the international panel representing 19 countries in light of the updated national therapy recommendations of the AGO (Arbeitsgemeinschaft Gynäkologische Onkologie). Therefore, 14 German breast cancer experts, 3 of whom are members of the International St. Gallen Panel, have commented on the voting results of the St. Gallen Consensus Conference 2015 in relation to clinical routine in Germany