scholarly journals Are powder-technology-built stems safe? A midterm follow-up registry study

Author(s):  
Francesco Pardo ◽  
Barbara Bordini ◽  
Francesco Castagnini ◽  
Federico Giardina ◽  
Cesare Faldini ◽  
...  

Abstract Background Powder technology was developed to bring together the mechanical features and high porosity of titanium. However, the high porosity may theoretically compromise mechanical resistance. Literature is deficient about the use and safety profile of cementless femoral implants built using additive manufacturing (in particular electron beam melting technology, EBM). The purpose of this study was to evaluate the survival rates and the reason for revisions (especially implant breakage) of the first two EBM-built stems at a mid-term follow-up, using a joint arthroplasty registry. Methods The registry of Prosthetic Orthopedic Implant (RIPO) was investigated about cementless stems implanted from 2010 to 2017. Stems built with EBM technology (Parva and Pulchra stems; Adler Ortho, Milan, Italy) were compared to all the other cementless stems implanted during the same period, acting as control group. The survival rates and reasons for revision were assessed. Results No stem breakage occurred. At 5-year follow-up, the survival rates of the two cohorts were not statistically different (96.8% EBM stems, 98.0% standard cementless stems; p > 0.05). In the EBM stems, aseptic loosening occurred in 1.7% of the cases at the latest follow-up. Conclusions This large cohort showed that mechanical resistance is not a concern in EBM stems at mid-term follow-up. However, larger populations and longer follow-ups are needed to further validate these results.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e22506-e22506
Author(s):  
Yuanjue Sun ◽  
Yang Yao ◽  
Zhengdong Cai ◽  
Xiuchun Yu ◽  
Sujia Wu ◽  
...  

e22506 Background: to study the progression free survival (PFS), objective response rate (ORR), overall survival (OS) and safety of lobaplatin or gemcitabine combined with docetaxel as second-line therapy for advanced osteosarcoma. Methods: the NO. of clinical trial was HNCA001,a total of 15 cases were enrolled into experiment group adopted lobaplatin combined with docetaxel,and 14 into control group received gemcitabine combined with docetaxel.The trial concluded screening, treatment and follow-up periods.21 dyas as one treatment period,they got drugs at the first day,and were evaluated the effects per two periods, treated at most 6 periods. Results: The baseline characteristics of two groups were no ststistical differences(diastolic blood pressure excluded) (P > 0.05).The PFS rates of 2,4 and 6 periods in experiment group were 87.50%、87.50% and 70.00%,83.33%,27.78% and 0 in control group,middle PFS more than 12 months in experiment group and 3.20 months in control group;while there was no statistical difference of PFS rates(χ2= 2.42,P = 0.1194).The survival rates of 2,4 and 6 periods in experiment group were 100.00%,83.33% and 83.33%,83.33%,83.33% and 0 in control group,the middle OS more than 12 months in the two groups, there was no statistical difference of survival rates (χ2= 0.65,P = 0.4196).The ORR was 6.67% in experiment group and 0 in control group(P = 1.0000).There were no adverse events occurring in the two groups. Conclusions: There is negative results of the trial,most reason may be the samples are greatly less;the next step is samples expanded and follow-up extended for the priority of lobaplatin or gemcitabine combined with docetaxel as second-Line therapy for advanced osteosarcoma. Clinical trial information: NCT02099396.


2017 ◽  
Vol 2017 ◽  
pp. 1-16 ◽  
Author(s):  
Alessandro Cucchi ◽  
Elisabetta Vignudelli ◽  
Simonetta Franco ◽  
Luca Levrini ◽  
Dario Castellani ◽  
...  

Purpose. To evaluate the survival, success, and complication rates of tapered double-lead threads single implants, placed in fresh extraction sockets and healed sites of the posterior jaws. Methods. The enrolled patients were randomly divided into 2 groups: in the test group (TG), all implants were inserted at the time of tooth extraction; in the control group (CG), all implants were placed 3 months after extraction. The implants were followed for a period of 1 to 3 years after loading. The main outcomes were implant survival, complications, and implant-crown success. Results. Ninety-two patients had 97 installed implants (49 in the TG, 48 in the CG). Only two implants failed, in the TG; the survival rates were therefore 95.9% (47/49) and 100% (48/48) for TG and CG, respectively. In the surviving implants, no complications were reported, for an implant-crown success of 100%. Conclusions. Although a significant difference was found in the levels of primary stability between TG and CG, single implants placed in fresh extraction sockets and healed sites of the posterior jaws had similar survival and complication rates. Crestal bone levels and peri-implant bone resorption showed similar values. A longer follow-up period is however required, to confirm these positive outcomes.


2010 ◽  
Vol 51 (1) ◽  
pp. 20-23 ◽  
Author(s):  
Marisa Maltz ◽  
Mauricio Moura ◽  
Juliana Jobim Jardim ◽  
Cyntia Marques ◽  
Lilian Marly De Paula ◽  
...  

The aim of this multicenter randomized controlled clinical trial was to evaluate the effectiveness of partial caries removal followed by restoration in a single session (PDR) for deep caries lesions in Brazil (Porto Alegre and Brasilia) after 2-year follow-up. Inclusion criteria: patients with ≥ six years old presenting permanent molars with primary deep lesion, absence of periapical alterations, pulp sensitivity, absence of spontaneous pain and negative percussion test. The subjects were randomly assigned to test group - PDR, or control group - stepwise excavation (SW). SW consisted of partial removal of carious dentine, indirect pulp capping with calcium hydroxide cement, temporary filling, cavity re-opening after 60 days, removal of the remaining soft carious dentine and filling. Each group was divided according to the filling material: amalgam or resin. Clinical and radiographic evaluations were performed in annual basis. The outcomes were considered as pulp sensibility to cold test and absence of periapical alterations. There were performed 299 treatments, 153 PDR and 146 SW. There were no differences between the groups regarding baseline characteristics. After 2 years of follow-up, 204 restorations were evaluated and the therapy survival rates of PDR and SW were 95.45% and 80.85%, respectively (p=0.001). Reasons for failure: pulpitis, osteitis, hyperemia, necrosis, extraction and restoration fracture.. None variable was significantly associated with the outcome. From these results, it is possible to conclude that the PDR is a more successful treatment than SW. (Registration number at www.clinicaltrials.gov NCT00887952).


2019 ◽  
Vol 9 (20) ◽  
pp. 4296 ◽  
Author(s):  
Marcos ◽  
Perrotti ◽  
Iaculli ◽  
Aragones ◽  
Benfatti ◽  
...  

This in vitro study aimed at evaluating the physical and mechanical properties of newly developed scaffolds of poly (lactic-co-glycolic acid) (PLGA) and biphasic ceramic (Hydroxyapatite HA + beta-tricalciumphosphate β-TCP) with or without collagen impregnation to be used for bone regeneration in the oral and maxillofacial district. Solvent casting and particle leaching techniques were used to produce the scaffolds, which were then divided into six groups according to PLGA/HA + β-TCP ratio and impregnation with collagen: G1 (50/50) + collagen; G2 (60/40) + collagen; G3 (40/60) + collagen; G4 (50/50); G5 (60/40); G6 (40/60). As control group, inorganic xenogenous bone was used. Structure and porosity were evaluated by scanning electron microscopy, and a chemical analysis was performed through an energy-dispersive spectrometer. Moreover, to evaluate the hydrophilicity of the samples, a wettability test was conceived, and finally, mechanical properties were examined by a compression test. High porosity and interconnectivity, resulting in a large surface area and great fluid retention capacity, were presented by the PLGA/HA + β-TCP scaffolds. In the composite groups, collagen increased the wettability and the mechanical resistance, although the latter was not statistically affected by the percentage of HA + β-TCP added. Further in vitro and in vivo studies are needed for a deeper understanding of the influence of collagen on the biological behavior of the developed composite materials and their potential, namely biocompatibility and bioactivity, for bone tissue regeneration.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1707-1707
Author(s):  
Maria F Tanaka ◽  
Elias Jabbour ◽  
Hagop M. Kantarjian ◽  
Sherry Pierce ◽  
Richard Champlin ◽  
...  

Abstract Abstract 1707 BACKGROUND: Treatment of pts with higher-risk MDS revolves around AHSCT and HMA. Although AHSCT is thought to be the only curative approach for pts with MDS, only a small percentage of pts are appropriate candidates and this procedure carries significant morbidity and mortality rates. We wanted to assess outcomes in pts with higher risk MDS treated with AHSCT or HMA. To study this, we performed a retrospective analysis comparing the outcome of pts with previously untreated MDS who received AHSCT or HMA therapy at M.D. Anderson Cancer Center (MDACC). METHODS: From a database of pts with MDS who received AHSCT (N=152) at MDACC between 01/1988 and 04/2008, we selected those with untreated MDS prior to receiving the transplant. A total of 53 (29%) pts were identified. We compared them with a control group of 40 pts treated with HMA among 1748 referred to MDACC. All controls were selected to match at least 3 of the following 5 criteria: 1) age, 2) year of diagnosis, 3) percentage of blasts at the time of diagnosis, 4) IPSS cytogenetic risk, and 5) time from diagnosis to treatment. The primary endpoint was survival. RESULTS: A total of 53 pts with untreated MDS who received AHSCT and 40 pts treated with HMA were identified (Table 1). Median age was 51 (range 20–62) and 54 (range 38–79) years for pts treated with AHSCT or HMA respectively. There were more pts greater than 60 years old in the HMA group compared to those in the AHSCT group (58% vs. 1% p>0.001). The median follow up time was 64 months. Donors were HLA matched related (n=37), matched unrelated (n=11), 1 antigen mismatched related (n=4) or 1 antigen mismatched unrelated (n=1). Of the 40 pts treated with HMA, 31 were evaluable for response; of those 31, 19 (61%) responded, 16 (52%) achieving a complete response. The median survival was 26 and 25 months for pts receiving AHSCT or HMA, respectively (p=0.41) (Figure 1). The 8-year overall survival rates for pts receiving AHSCT or HMA were 24% and 23% respectively. CONCLUSION: AHSCT did not offer a significant survival improvement in a retrospective analysis of pts with MDS. Treatment with a HMA offers an adequate alternative in older patients or those who cannot tolerate or receive an AHSCT and should be used as a bridge in younger pts who are candidates for AHSCT Disclosures: No relevant conflicts of interest to declare.


2012 ◽  
Vol 35 (6) ◽  
pp. 444-449 ◽  
Author(s):  
Meltem Gursu ◽  
Berna Yelken ◽  
Yasar Caliskan ◽  
Rumeyza Kazancioglu ◽  
Halil Yazici ◽  
...  

Aims: The prognostic outcome of patients with amyloidosis who receive a kidney transplant is controversial. The aim of the study was to analyze the renal transplantation outcome of patients with amyloidosis compared to transplant recipients with other kidney diseases. Methods: Among 940 patients who had renal transplantation in our unit between 1983 and 2009, 44 patients with amyloidosis were compared regarding early and late complications and survival, retrospectively, with a control group of 41 consecutive patients with the same donor type and a matched renal transplantation date. Results: The groups were similar regarding demographic parameters, HLA mismatch numbers and mean follow-up period. Groups were similar regarding early and late infectious and non-infectious complications, except recurrence of the primary disease, which was more common in the amyloidosis group. As the cause of graft loss, rejection (acute or chronic) was more common in the control group; whereas primary non-functioning graft, and death with a functioning graft were more common in the amyloidosis group. Patient survival rates at 1, 5, and 10 years were 87.6%, 78.1%, and 62.3 in the amyloidosis group; and 93.2%, 82.6%, and 69.3% in the control group. Graft survival rates at 1, 5 and 10 years were 87.6%, 75.4%, 56.4% in the amyloidosis group; and 93.2%, 80.3%, and 60.6% in the control group, respectively. These values did not show any statistical difference. Conclusions: The outcomes of renal transplantation in patients with amyloidosis are comparable with recipients whose primary problems are due to other kidney diseases; therefore, amyloidosis patients should be accepted as good candidates for transplantation.


2012 ◽  
Vol 22 (6) ◽  
pp. 968-973 ◽  
Author(s):  
Ignacio Zapardiel ◽  
Michele Peiretti ◽  
Vanna Zanagnolo ◽  
Roberto Biffi ◽  
Luca Bocciolone ◽  
...  

BackgroundThe aim of surgical approach in advanced ovarian cancer should be the complete removal of all visible disease. Our purpose was to compare perioperative features and postoperative complications, and secondarily oncological outcomes, between patients who underwent splenectomy and those who did not at the time of surgery.Materials and MethodsThirty-three subjects underwent splenectomy, and we selected 99 controls with similar surgical characteristics but who did not undergo splenectomy. Data collected included perioperative details and follow-up data.ResultsLonger operating time (33 minutes longer;P= 0.02), larger estimated blood loss (812 mL more;P= 0.03), higher rate of intraoperative blood transfusions (78.8% vs 42.4%;P< 0.01), and intensive care unit stay (1.4 vs 0.5 days;P< 0.01) as well as higher pneumonia rate (2% vs 0%;P= 0.01) were observed in the splenectomy group. Disease-free and overall survival rates were 30.3% and 66.6%, respectively, in the splenectomy group, and 33.3% and 59.6%, respectively, in the control group.ConclusionsSplenectomy at the time of primary cytoreductive surgery for advanced ovarian cancer may contribute to achieve complete cytoreduction with low perioperative complication rate. This procedure seems to be an acceptable and rational intervention to increase the survival rates of those patients.


2020 ◽  
Vol 45 (5) ◽  
pp. 593-600
Author(s):  
Nahide Ekici-Günay ◽  
Serhat Koyuncu

AbstractObjectivesThis study investigates whether a diagnostic threshold value of procalcitonin exists in Crimean-Congo hemorrhagic fever (CCHF), while also determining the correlation between serum procalcitonin and routine diagnostic laboratory markers, monitoring changes in procalcitonin levels over time during hospitalization, and exploring the effect of procalcitonin levels on survival rates.MethodsA total of 161 patients, including 100 with laboratory-confirmed diagnosis of CCHF and 61 as a control group, were retrospectively investigated. Receiver operating characteristics (ROC) curve analysis was performed to evaluate the contribution of procalcitonin when diagnosing the onset in CCHF patients. Procalcitonin levels were measured with Diazyme latex-enhanced immunoturbidimetric method in Roche Cobas C501 analyzer. A Mann–Whitney U-test was applied to compare the groups, a Mantel–Haenszel (log-rank) test was used to calculate for graphic of original individual patient time-to-event data, and a Kaplan–Meier survival curve was plotted.ResultsA ROC curve analysis identified a best predictive procalcitonin level cut-off point of 0.560 μg/L, with a specificity of 97% and sensitivity of 27% for CCHF. The highest levels of procalcitonin were measured on day 2 during the follow-up throughout and on the 5th day peaked for a second time, lower than the first.ConclusionsProcalcitonin may serve as prognostic indicator and an auxiliary biomarker to rule out of CCHF.


Author(s):  
Ute Ritterfeld ◽  
Timo Lüke

Abstract. Audio stories offer a unique blend of narrative entertainment with language learning opportunities as a user’s enjoyment is dependent on their processing of the linguistic content. A total of 138 third- and fourth-graders from low socioeconomic status and migrant families recruited from a metropolitan area in Germany participated in a randomized pre–post follow-up intervention study with a control group. Children listened to a tailored crime story of approximately 90 min over a period of 3 days within the classroom setting. Entertainment value for the age group was established in a pilot study. Outcome variables included semantic and grammatical skills in German and were administered before (pretest), shortly after intervention (posttest), and 2 weeks later (follow-up). We used nonverbal intelligence, reading, comprehension skills, age and sex as control variables. Results indicate a strong positive effect of media reception on language skills. The effectiveness of the intervention is discussed with reference to different linguistic domains, entertainment value, and compensatory effects in populations at risk of language learning deficits.


2005 ◽  
Vol 44 (05) ◽  
pp. 185-191 ◽  
Author(s):  
H. Wieler ◽  
S. Birtel ◽  
E. Ostwald-Lenz ◽  
K. P. Kaiser ◽  
H. P. Becker ◽  
...  

Summary:Aim: For the surgical therapy of differentiated thyroid cancer precise guidelines are applied by the German medical societies. In a retrospective multicenter study, we investigated the following issues: Are the current guidelines respected?. Is there a difference concerning the surgical radicalism and the outcome?. Does the perioperative morbidity increase with the higher radicalism of the procedure?. Patients, methods: Data gained from 102 patients from 17 regional referral hospitals who underwent surgery for thyroid cancer and a following radioiodine treatment (mean follow up: 42.7 [24-79] months) were analyzed. At least 71 criterias were analyzed in a SPSS file. Results: 46.1% of carcinomas were incidentally detected during goiter surgery. The thyroid cancer (papillary n = 78; follicular n = 24) occurred in 87% unilateral and in 13% bilateral. Papillary carcinomas <1 cm were detected in 25 cases; in five of these cases (20%) contralateral carcinomas <1 cm were found. There were significant differences concerning the surgical radicalism: a range from hemithyroidectomy to radical thyroidectomy with lateral neck dissection. Analysis of the histopathologic reports revealed that lymph node dissection was not performed according to guidelines in 55% of all patients. The perioperative morbidity was lower in departments with a high case load. The postoperative dysfunction of the recurrent laryngeal nerve (mean: 7.9% total / 4.9% nerves at risk) variated highly, depending on differences in radicalism and hospitals. Up to now these variations in surgical treatment have shown no differences in their outcome and survival rates, when followed by radioiodine therapy. Conclusion: Current surgical regimes did not follow the guidelines in more than 50% of all cases. This low acceptance has to be discussed. The actual discussion about principles of treatment regarding, the socalled papillary microcarcinomas (old term) has to be respected within the current guidelines.


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