scholarly journals Elastoplasty: A Silicon Polymer as a New Filling Material for Kyphoplasty in Comparison to PMMA

2016 ◽  
Vol 6;19 (6;7) ◽  
pp. E885-E892
Author(s):  
Rahel Bornemann

Background: Painful vertebral compression fractures (VCF) caused by osteoporosis are a common health problem in the elderly population. If conservative treatments are unsuccessful, surgical treatments like vertebroplasty or kyphoplasty are recommended. But the use of Polymethylmethacrylat (PMMA) bone cement for augmentation surgery is associated with risks. Objectives: Evaluation of the effectiveness and safety of a newly developed silicon polymer (VK100) that can be used instead of PMMA bone cement for kyphoplasty treatments. Study Design: A retrospective study of 30 patients comparing the outcomes of kyphoplasty treatments conducted with PMMA and VK100. Setting: Clinic for Orthopedics and Trauma Surgery Bonn, Germany. Methods: Thirty patients with one to 3 VCF were treated either with balloon kyphoplasty using VK100 or balloon kyphoplasty using PMMA bone cement. Data from both groups was compared by a matched pair analysis. The medial vertebral height was measured at each examination radiologically. The patients stated their pain intensity using the Visual Analogue Scale (VAS) and the patient’s functional impairment was evaluated with the Oswestry-Disability-Index (ODI). All data were assessed before surgery, and 3 days, 3 months, 6 months, and 12 months after surgery. Intraoperative and postoperative adverse events were documented. Results: The patients’ functional impairment and pain improved significantly after surgery. The course of ODI and VAS was comparable in both treatment groups, but the improvement in the VK group was significantly ongoing until the 12 month follow-up. Vertebral height improvement was significant in both groups, but the PMMA group achieved a better absolute restoration. The vertebral height stayed constant during the follow-up in the VK group and worsened significantly in the PMMA group. There was no significant difference between groups concerning the occurrence of additional fractures; and no other types of complications or surgery-related adverse events were observed in either the PMMA group or in the VK group. Limitations: The study is only a matched pair analysis of 15 patients for each procedure and the amount of injected filling material was not recorded. Conclusion(s): The study results demonstrate that the clinical outcome of VAS and ODI of using the silicon polymer VK100 is comparable or slightly better than using PMMA. VK 100 shows a trend to minor additional fractures during the follow-up. However, height restoration is not satisfactory in comparison to PMMA, although vertebral height stayed more or less constant in the VK group. To address the augmentation success further, it would be necessary to study a larger patient group over a longer study period and to assess additional parameters such as bone density and injected amount of filling material. Key words: Vertebral compression fracture, kyphoplasty, augmentation, osteoporosis, back pain, VK 100, elastoplasty

2016 ◽  
Vol 97 (2) ◽  
pp. 142-147 ◽  
Author(s):  
Sebastian Nestler ◽  
Patrick Levien ◽  
Andreas Neisius ◽  
Christian Thomas ◽  
Mohammed M. Kamal ◽  
...  

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4529-4529
Author(s):  
Arne Trummer ◽  
Juergen Krauter ◽  
Michael Stadler ◽  
Arnold Ganser ◽  
Stefanie Buchholz

Abstract Abstract 4529 Published data about outcome after cryopreserved allogeneic peripheral blood stem cell transplantation are scarce and, so far, have only been compared to historic cohorts of fresh graft recipients. We have performed a matched pair analysis of 66 patients receiving either cryopreserved or fresh grafts from matched related donors at our institution between January 2005 and June 2011 with a median follow-up time of 576 days (range: 18–2080 days). For matching patients we calculated a propensity score including patient age, sex, diagnosis, performance status, remission status before transplantation (first remission vs. other), conditioning therapy (standard vs. reduced intensity), GvHD prophylaxis (with or without methotrexate) and CD34 cell count in the graft. Consequently, there were no significant differences between both groups for these parameters: median patient and donor age were 53 years (range: 18–68 and 23–76 years, respectively) for 34 male and 32 female patients with a performance status of ECOG 0 (n=60) or ECOG 1 (n=6). Diagnoses were AML (n=47), ALL (8), lymphoma (10) and CMPN (1). 31 patients were in first remission before transplantation. Reduced intensity conditioning therapy (n=52) and GvHD prophylaxis without methotrexate (n=41) were more frequent than standard conditioning (n=14) and prophylaxis with methotrexate (n=25), respectively. Median cell counts were also almost equal in fresh and cryopreserved grafts for CD34 cells (5.7×106/kg (range: 3.1–11.4×106/kg) vs. 5.1×106/kg (2.6–12.3×106/kg), respectively), total nuclear cells (10.0×108/kg (4.9–21.4×108/kg) vs. 9.6×108/kg (5.0–19.1×108/kg) and CD3 lymphocytes (3.8×108/kg (2.1–6.8×108/kg vs. 3.4×108/kg (0.6–4.5×108/kg)). All patients engrafted. Median neutrophil engraftment with an ANC >0.5×109/l was reached after 16 days (range: 10–21) vs. 15 days (10–31) (p=.15 by paired t-test) and platelet engraftment >20×109/l (for 3 consecutive days without requiring transfusion) occurred after 13 days (8–33) vs. 14 days (9–45) (p=.27). Median follow-up time was similar between both groups (566 vs. 586 days, p=.894) and mean overall survival time, as calculated by Kaplan-Meyer analysis, was 1113 days for patients receiving fresh compared to 1258 days for patients receiving cryopreserved grafts (p=.582 by log rank test). Relapse or progression occurred in 13 vs. 14 patients, giving a mean disease/progression-free survival time of 922 vs. 1114 days (p=.467). In summary, we did not observe any relevant outcome differences between patients receiving fresh or cryopreserved peripheral stem cell grafts of matched related donors. Therefore, the use of cryopreserved grafts can be considered safe and may even allow a more flexible transplant scheduling compared to fresh allografts. Disclosures: No relevant conflicts of interest to declare.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1120-1120 ◽  
Author(s):  
Elena Sperk ◽  
Daniela Astor ◽  
Grit Welzel ◽  
Axel Gerhardt ◽  
Marc Suetterlin ◽  
...  

1120 Background: After breast conserving surgery, radiotherapy leads to a better overall survival. In addition to whole breast radiotherapy (WBRT) a boost to the tumor bed leads to a better local control. The tumor bed boost is usually added after WBRT or can be done intraoperative (IORT). Belletti et al. (Clin Cancer Res., 2008) described positive effects, an antitumoral effect and modulation of microenvironment after IORT with 50kV x-rays. A matched pair analysis was performed to investigate the impact of IORT boost on overall survival compared to standard external beam boost. Methods: Between 2002 – 2009, 370 patients were treated for breast cancer with WBRT + boost (external beam (EBRT) boost n = 146, IORT boost n =224). A matched pair analysis (1:1 propensity score matching for age, TNM, grading, hormonal treatment and chemotherapy) for overall survival and local recurrence free survival could be done for 53 pairs. All patients underwent breast conserving surgery and WBRT with 46-50Gy. 53 patients received an EBRT boost with 16Gy (2Gy/fraction, dedicated linear accelerator) and 53 patients received an IORT boost with 20Gy (INTRABEAM system, 50kV x-rays). Median follow-up was 6 months (range, 1-77 months) for the EBRT boost patients and 56 months (range, 2-97 months) for IORT boost patients. Kaplan Meier estimates were performed for overall survival and local recurrence free survival. Results: IORT boost patients had a longer follow-up than EBRT boost patients. Despite the difference in follow-up times, there was a strong trend towards better overall survival after IORT boost (90.2% vs. 62.3%, p = 0.375). One local recurrence was present in each group (EBRT boost after 15 months, local recurrence free survival 95%; IORT boost after 12 months, local recurrence free survival 98.1%). Conclusions: IORT given as a boost seems to have a positive impact on overall survival in breast cancer patients after breast conserving surgery. To identify such an effect a prospective randomized trial should be conducted.


2001 ◽  
Vol 37 ◽  
pp. S185
Author(s):  
H. Sommer ◽  
W. Janni ◽  
B. Strobl ◽  
D. Rjosk ◽  
C. Schindlbeck ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e056940
Author(s):  
Nico Gross ◽  
Lucas M Bachmann ◽  
Meriam Islam ◽  
Livia Faes ◽  
Martin K Schmid ◽  
...  

ObjectiveWe compared patients with neovascular age-related macular degeneration (nvAMD), diabetic macular oedema (DMO) and other macular pathologies testing their vision with the hyperacuity home-monitoring app Alleye to patients not performing home-monitoring regarding clinical outcomes and clinical management.DesignMatched-pair analysis.SettingRetina Referral Centre, Switzerland.ParticipantsFor each eye using Alleye, we matched 2–4 controls not using home-monitoring based on age, gender, number of previous intravitreal injections (IVI), best corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study letters), central macular thickness (CRT) and time point of enrolment, using the Mahalanobis distance matching algorithm. We included 514 eyes (288 patients); 107 eyes with nvAMD using home monitoring and 218 controls not using home monitoring, 25 eyes with DMO (n=52 controls) and 40 eyes with miscellaneous conditions (n=72 controls). 173 eyes (33.7%) received no IVI during follow-up.Main outcome measuresImprovement of ≥5 letters, number of injection visits and treatment retention after correcting for differences in baseline characteristics with multivariate analyses.ResultsThe mean follow-up duration was 809 days (range 147–1353) and the mean number of IVI/year among treated eyes was 6.7 (SD 3.1). Mean age at baseline was 70.4 years (SD 10.9), BCVA was 77.6 letters (SD 11.6) and CRT was 263.6 µm (SD 86.7) and was similar between patients using and not using home monitoring. In multivariate analyses, patients using home monitoring had a higher chance to improve visual acuity by ≥5 letters (OR 1.67 (95% CI 1.01 to 2.76; p=0.044)) than controls. Treated eyes using home monitoring had less injection visits/year (−0.99 (95% CI −1.59 to −0.40; p=0.001)) and a longer treatment retention +69.2 days (95% CI 2.4 to 136.0; p=0.042). These effects were similar across retinal pathologies.ConclusionsThis data suggest that patients capable of performing mobile hyperacuity home monitoring benefit in terms of visual acuity and discontinue treatment less often than patients not using home monitoring.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2403-2403 ◽  
Author(s):  
Régis Peffault de Latour ◽  
Hubert Schrezenmeier ◽  
Andrea Bacigalupo ◽  
Didier Blaise ◽  
Carmino Antonio De Souza ◽  
...  

Abstract Abstract 2403 Background: Hematopoietic Stem Cell Transplantation (HSCT) is the only curative treatment for paroxysmal nocturnal hemoglobinuria (PNH). However, the risk of treatment-related mortality (TRM) usually leads to postponing HSCT in PNH until disease progression (especially in case of life-threatening thromboembolism (TE) or severe aplastic anemia (SAA)). Recent studies demonstrated that eculizumab, a C5-inhibitor, is highly effective in reducing intravascular hemolysis with protective effect on the risk of TE. Today, identifying PNH patients (pts) who may benefit from HSCT represents a particularly difficult challenge. We thus conducted an overall survival (OS) comparison between a cohort of transplanted PNH pts and a matched cohort of non-transplanted PNH pts before the eculizumab era. Patients and methods: This retrospective multi-center study was conducted through the SAA WP of the EBMT and the SFH. Between 1978 and 2008, 211 pts with PNH who were transplanted have been reported to the EBMT registry. Data concerning another 401 non-transplanted PNH pts came from the SFH (Peffault de Latour Blood et al., 2008). The OS comparison between the 2 cohorts was performed from the time of life-threatening complication occurrence among pts who experienced the same type of complication, being either TE or SAA. Among pts who experienced one of these complications, two matching procedures were applied in order to select non-transplanted pts comparable to transplanted pts. First, an individual matching procedure was completed using the following complication occurrence criteria: severity, patient age (per decade), year (per decade), and the delay between diagnosis of PNH and complication occurrence (relatively to 3 or 6 months). In addition, the survival time from complication for a non-transplanted patient should be longer than the delay from the complication to HSCT for the corresponding transplanted patient. In a second step, a global matching procedure was performed using the same qualitative prognostic factors. For each factor related to OS within one cohort, a category was discarded from the analysis in the absence or too few numbers of pts in one cohort. After these selections, OS-related factors allowed us to define strata through their combination. OS comparisons between cohorts were performed by using proportional hazards models stratified on each individual matched pair, or adjusted on strata to allow interaction test between cohort and stratum. Results: After a median follow-up time of 5 yrs, the 5-yr OS rate (SE) was 68% (3%) in the transplanted pts group (75 received HSCT from unrelated donors). The only factor associated with OS was the indication for HSCT with worse outcome when the indication was TE (p=0.03). In the non-transplanted cohort, the 5-yr OS rate was 83% (2%) after a median follow-up time of 7 yrs. From the 122 pts diagnosed with TE in the SFH cohort, 92 were eligible for the matched-pair analysis, while from the 47 pts who were transplanted for TE in the EBMT population, 42 were eligible. We then identified 24 pairs of transplanted and non-transplanted pts eligible for the matched-pair comparison. Worst OS was observed for transplanted pts (p=0.007, HR=10.0 [95%CI, 1.3 – 78.1]). In the global matching analysis, we derived 2 prognostic strata: stratum A (age <30 yrs and delay from diagnosis of PNH to TE ≥ 3 months, or delay < 3 months) and stratum B (age ≥30 yrs and delay from diagnosis of PNH to TE ≥ 3 months). Adjusted analysis on prognostic strata is presented in Figure 1. From the 141 pts experiencing SAA in the SFH cohort, 99 were eligible for the matched-pair analysis, while from the 119 pts who were transplanted for SAA in the EBMT population, 100 were eligible. We then identified 30 pairs of transplanted and non-transplanted pts eligible for the matched-pair comparison. Worst OS was observed for transplanted pts, but the difference was not statistically significant (p=0.06, HR=4.0 [0.9–18.9]). The global matching was not feasible for pts experiencing SAA because the procedure led to too many strata. Conclusion: Our analysis indicates that HSCT is probably not a good treatment option for life-threatening TE in PNH pts. We can make no conclusions regarding PNH pts experiencing SAA due to the impossibility to perform the global matching procedure. These results are of particular importance in the eculizumab era to help physicians in the management of PNH pts, especially pts with TE. Disclosures: Peffault de Latour: Alexion: Consultancy, Research Funding.


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