scholarly journals Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures

Author(s):  
Stefano Marcia ◽  
Emanuele Piras ◽  
Joshua A. Hirsch ◽  
Alessio Mereu ◽  
Mariangela Marras ◽  
...  

Abstract Purpose To evaluate the safety and efficacy of a novel augmentation implant in the treatment of patients with symptomatic vertebral body fractures. Materials and Methods Thirty consecutive patients (seven males and 23 females), mean age of 70 years (range 56 to 89) with osteoporotic fractures and/or low-energy trauma fractures (osteoporosis confirmed by CT), were enrolled in an IRB-approved prospective study. The type of fracture was classified according to the Magerl classification. The patients were treated with the Tektona® dedicated vertebral body augmentation system. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were obtained after 1, 6 and 12 months. Quality of life was assessed with the SF36 score. Results A total of 37 vertebral bodies, mostly from T6 to L5, were treated in the 30 enrolled patients. In 67.6% of the cases (n = 25), lumbar fractures were treated. Most of the fractures (43%; n = 16) were A1.1 according to the Magerl classification. A significant pain reduction evaluated by VAS scores (p < 0.0001) was observed on average 7.6 (before the procedure) to 2.8 (immediately post-treatment), 2.1 and 2.7 (after 6 and 12 months later, respectively). The mean ODI score was 55.5% before treatment, and this was statistically significant reduced to 22.3% and 26.9%, respectively, at 6 and 12 months after treatment (p < 0.0001). The SF36 scores, both physical and mental components, showed statistically significant variations (p < 0.0001) whose direction was subpopulation dependent. Conclusion Patients with confirmed osteoporosis, suffering from symptomatic vertebral body fractures (osteoporotic and/or low-energy traumatic), were treated safely and effectively using this novel implant.

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1554
Author(s):  
Vincius Tieppo Francio ◽  
Benjamin Gill ◽  
Adam Rupp ◽  
Andrew Sack ◽  
Dawood Sayed

Low back pain is consistently documented as the most expensive and leading cause of disability. The majority of cases have non-specific etiologies. However, a subset of vertebral diseases has well-documented pain generators, including vertebral body tumors, vertebral body fractures, and vertebral endplate injury. Over the past two decades, specific interventional procedures targeting these anatomical pain generators have been widely studied, including spinal tumor ablation, vertebral augmentation, and basivertebral nerve ablation. This scoping review summarizes safety and clinical efficacy and discusses the impact on healthcare utilization of these interventions. Vertebral-related diseases remain a top concern with regard to prevalence and amount of health care spending worldwide. Our study shows that for a subset of disorders related to the vertebrae, spinal tumor ablation, vertebral augmentation, and basivertebral nerve ablation are safe and clinically effective interventions to decrease pain, improve function and quality of life, and potentially reduce mortality, improve survival, and overall offer cost-saving opportunities.


Author(s):  
Ulrich Josef Spiegl ◽  
Max Joseph Scheyerer ◽  
Georg Osterhoff ◽  
Sebastian Grüninger ◽  
Klaus John Schnake

Abstract Purpose The aim of this systematically review is to detect differences between fractures located at the mid-thoracic spine compared to fractures of the thoracolumbar junction (TLJ) and the lumbar spine in osteoporotic vertebral body fractures. Methods This review is based on articles retrieved by a systematic search in the PubMed and Web of Science database for publications regarding osteoporotic fractures of the thoracolumbar spine with respect to the fracture location. Differences in prevalence, cause of fracture, fracture healing, and outcomes between the mid-thoracic spine and the TLJ and the lumbar spine were considered. Results Altogether, 238 articles could be retrieved from the literature search. A total of 222 articles were excluded. Thus, 16 remaining original articles were included in this systematic review comprising the topics prevalence, bone mineral density and regional blood flow, biomechanics, subsequent fractures, and outcome, respectively. The overall level of evidence of the vast majority of studies was moderate to low. Conclusion Several differences between osteoporotic fractures of the mid-thoracic spine compared to the TLJ and the lumbar spine could be identified. Thereby, osteoporotic mid-thoracic fractures seem to be particularly more related to frailty without a history of traumatic injury compared to osteoporotic fractures of the TLJ and the lumbar spine. Additionally, the presence of severe mid-thoracic fractures predicts subsequent fractures of the hip. In contrast, subsequent fractures of the spine are less likely.


2018 ◽  
Vol 11 (6) ◽  
pp. 603-609 ◽  
Author(s):  
Alessandro Cianfoni ◽  
Daniela Distefano ◽  
Maurizio Isalberti ◽  
Michael Reinert ◽  
Pietro Scarone ◽  
...  

ObjectivesTo describe a new technique to obtain minimally invasive but efficient vertebral body (VB) reconstruction, augmentation, and stabilization in severe osteoporotic and neoplastic fractures, combining two pre-existing procedures. The implant of vertebral body stents (VBS) is followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws that act as anchors to the posterior elements for the cement/stent complex. The screws reduce the risk of stent mobilization in a non-intact VB cortical shell and bridge middle column and pedicular fractures. This procedure results in a 360° non-fusion form of vertebral internal fixation that may empower vertebral augmentation and potentially avoid corpectomy in challenging fractures.Procedure detailsThis report provides step-by-step procedural details, rationale, and proposed indications for this procedure. The procedure is entirely percutaneous under fluoroscopic guidance. Through transpedicular trocars the VBS are inserted, balloon-expanded and implanted in the VB. Over k-wire exchange the transpedicular screws are inserted inside the lumen of the stents and cement is injected through the screws to augment the stents and fuse the screws to the stents.ApplicationsThis technique may find appropriate applications for the most severe osteoporotic fractures with large clefts, high-degree fragmentation and collapse, middle column and pedicular involvement, and in extensive neoplastic lytic lesions.ConclusionsStent-Screw-Assisted Internal Fixation (SAIF) might represent a minimally invasive option to obtain VB reconstruction and restoration of axial load capability in severe osteoporotic and neoplastic fractures, potentially obviating the need for more invasive surgical interventions in situations that would pose significant challenges to standard vertebroplasty or balloon kyphoplasty.


Author(s):  
Brian D. Stemper ◽  
Narayan Yoganandan ◽  
Jamie L. Baisden ◽  
Frank A. Pintar ◽  
Barry S. Shender

Quantification of lumbar spine vertebral body tolerance to axial compressive loads is important to understand the biomechanics of injury and for the development of safety enhancements. While fracture tolerance for isolated lumbar vertebral bodies has been outlined in multiple experimental studies, compressive rates were generally in the quasi-static range (e.g., 5 mm/min) [1–4]. However, vertebral body fractures most commonly occur under dynamic mechanisms such as falls from height. In the military environment, lumbar fractures were demonstrated following aviator ejection, helicopter crashes, and underbody blast events involving improvised explosive devices. Vertebral body compression during those events is likely to be orders of magnitude greater than quasi-static rates used previously [5]. Due to the loading rate dependence demonstrated for other tissues, including thoracic vertebrae [6], arteries [7], ligaments [8], and isolated spines [9], tolerance limits obtained from quasi-static testing are not likely applicable for the dynamic loading environment. Therefore, this study was conducted to quantify dynamic fracture biomechanics of lumbar vertebrae.


1991 ◽  
Vol 223 ◽  
Author(s):  
Hans P. Zappe ◽  
Gudrun Kaufel

ABSTRACTThe effect of numerous plasma reative ion etch and physical milling processes on the electrical behavior of GaAs bulk substrates has been investigated by means of electric microwave absorption. It was seen that plasma treatments at quite low energies may significantly affect the electrical quality of the etched semiconductor. Predominantly physical plasma etchants (Ar) were seen to create significant damage at very low energies. Chemical processes (involving Cl or F), while somewhat less pernicious, also gave rise to electrical substrate damage, the effect greater for hydrogenic ambients. Whereas rapid thermal anneal treatments tend to worsen the electrical integrity, some substrates respond positively to long-time high temperature anneal steps.


2020 ◽  
pp. 1-9
Author(s):  
Lisa Goudman ◽  
Ann De Smedt ◽  
Koen Putman ◽  
Maarten Moens ◽  
_ _

OBJECTIVEIn recent years, the use of high-dose spinal cord stimulation (HD-SCS) as a treatment option for patients with failed back surgery syndrome (FBSS) has drastically increased. However, to the authors’ knowledge a thorough evaluation of health-related quality of life (HRQOL) and work status in these patients has not yet been performed. Moreover, it is unclear whether patients who are treated with HD-SCS can regain the same levels of HRQOL as the general population. Therefore, the aims of this study were to compare the HRQOL of patients who receive HD-SCS to HRQOL values in an age- and sex-adjusted population without FBSS and to evaluate work status in patients who are receiving HD-SCS.METHODSHRQOL, measured with the 3-level EQ-5D (EQ-5D-3L), and work status were evaluated in 185 FBSS patients at baseline (i.e., before SCS) and at 1, 3, and 12 months of treatment with HD-SCS. Difference scores in utility values between patients and an age- and sex-adjusted normal population were calculated. One-sample Wilcoxon tests were used to assess the EQ-5D-3L difference scores. Mixed models were used to evaluate the evolution over time in EQ-5D-3L utility scores and EQ-5D visual analog scale (VAS) scores in patients and matched controls. Quality-adjusted life-years (QALYs) were calculated using the area under the curve method.RESULTSAn overall significant increase in EQ-5D-3L utility scores and EQ-5D VAS scores was found over time in the patient group. Wilcoxon tests indicated that the difference scores in utility values between patients and the normal population were significantly different from zero at all time points. The median incremental QALY after 12 months of HD-SCS was 0.228 (Q1–Q3: 0.005–0.487) in comparison to continued conservative treatment. At 12 months, 13.75% of patients resumed work.CONCLUSIONSHD-SCS may lead to significantly increased HRQOL at 12 months in patients with FBSS. Despite the increase, reaching the HRQOL level of matched controls was not achieved. Only a limited number of patients were able to return to work. This finding indicates that specialized programs to enhance return to work may be beneficial for patients undergoing SCS.


2020 ◽  
Vol 2020 (12) ◽  
Author(s):  
Alison M Wallace ◽  
George D Oreopoulos ◽  
Yoga R Rampersaud ◽  
Thomas K Waddell

Abstract Here we describe the successful outcome of a complex and challenging resection of a left-sided pancoast tumour involving the left subclavian artery and vertebral bodies. The resection was performed following neoadjuvant chemoradiotherapy in a multi-staged fashion involving multiple teams including thoracic surgery, plastic surgery, neurosurgery and vascular surgery. Each operation was less than 6 h, without complication, and the patient was discharged within 1 week of each procedure. This case report highlights the importance of multidisciplinary team collaboration and planning in order to achieve a successful oncologic outcome and a good quality of life following treatment of these challenging tumours. The patient had a good functional outcome and no evidence of recurrence 1.5 years later.


Medicina ◽  
2021 ◽  
Vol 57 (6) ◽  
pp. 584
Author(s):  
Puck C. R. van der Vet ◽  
Jip Q. Kusen ◽  
Manuela Rohner-Spengler ◽  
Björn-Christian Link ◽  
Roderick M. Houwert ◽  
...  

Background and objective: Falls in elderly cause injury, mortality, and loss of independence, making Fear of Falling (FoF) a common health problem. FoF relates to activity restriction and increased fall risk. A voluntary intervention including fall risk assessment and prevention strategies was implemented to reduce falls in elderly patients with low energy fractures (LEF). The primary purpose of this study was to evaluate FoF and the number of subsequent falls in trauma patients one year after a LEF. The secondary aim was to examine how FoF affects patients’ lives in terms of Quality of Life (QoL), mobility, and activity levels. Finally, participation in the voluntary fall prevention program (FPP) was evaluated. Materials and Methods: Observational cohort study in one Swiss trauma center. LEF patients, treated between 2012 and 2015, were analyzed one year after injury. Primary outcomes were Falls-Efficacy Score-International (FES-I) and number of subsequent falls. Secondary outcomes were EuroQoL-5-Dimensions-3-Levels (EQ5D-3L), mobility, activity levels, and participation in the FPP. Subgroup analysis was performed for different age categories. Results: 411 patients were included for analysis. Mean age was 72 ± 9.3, mean FES-I was 21.1 ± 7.7. Forty percent experienced FoF. A significant negative correlation between FoF and QoL (R = 0.64; p < 0.001) was found. High FoF correlated with lower activity levels (R= −0.288; p < 0.001). Six percent visited the FPP. Conclusions: At follow-up, 40% suffered from FoF which seems to negatively affect patients’ QoL. Nevertheless, participation in the FPP was low. Simply informing patients about their susceptibility to falls and recommending participation in FPPs seems insufficient to motivate and recruit patients into FPPs. We suggest implementing repeated fall risk- and FoF screenings as standard procedures in the follow-up of LEF, especially in patients aged over 75 years.


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