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1.
Int Braz J Urol ; 45(6): 1180-1185, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31808406

RESUMO

OBJECTIVE: To evaluate long-term (5-10 years) outcomes of Minimally Invasive Surgical (MIS) kit insertion with Prolift® (non-absorbable) mesh compared to the use of Prolift M® (partially absorbable), for anterior vaginal wall prolapse repair. STUDY DESIGN: In this retrospective study we compared women undergoing MIS kit Prolift ® insertion (n=90) vs. Prolift M® insertion (n=79) for anterior vaginal wall prolapse repair between 2006 and 2012 at our Institution. A number of 169 women fulfilled the inclusion criteria and were included in the study. RESULTS: During the study period 128 women (76%) completed full follow-up; of them 58 (73%) following MIS kit Prolift® insertion, and 70 (88%) following MIS kit ProliftM® insertion. There was no signifi cant difference between the Prolift® and Prolift M® regarding parity (3.04 vs. 2.88, p=0.506), presence of hypertension (24.1% vs. 39.1%, p=0.088), diabetes mellitus (3.4% vs. 11.6%, p=0.109), or urinary stress incontinence (39.7% vs. 47.1%, p=0.475). All participants had been diagnosed with POP grade 3 or 4 before the procedure. No significant complications during the procedure or postoperative period were identified in the study groups. The follow-up period was at least five years in duration for both groups. Both groups were comparable according to questionnaires focused on function and satisfaction. CONCLUSION: Patients undergoing MIS kit Prolift® and Prolift M® insertion for anterior vaginal wall prolapse repair had comparable early and late postoperative outcomes. No differences in patient's function and satisfaction between the two groups were identified. According to our fi ndings, there is no superiority to either of the two studied mesh devices.


Assuntos
Implantes Absorvíveis , Telas Cirúrgicas , Prolapso Uterino/cirurgia , Implantes Absorvíveis/efeitos adversos , Idoso , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Diafragma da Pelve , Complicações Pós-Operatórias , Estudos Retrospectivos , Estatísticas não Paramétricas , Telas Cirúrgicas/efeitos adversos , Inquéritos e Questionários , Resultado do Tratamento , Prolapso Uterino/complicações , Prolapso Uterino/fisiopatologia
2.
Am Surg ; 85(11): 1269-1275, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31775970

RESUMO

Hiatal hernia repair (HHR) and fundoplication are similarly performed among all hiatal hernia types with similar techniques. This study evaluates the effect of HHR using a standardized technique for cruroplasty with a reinforcing polyglycolic acid and trimethylene carbonate mesh (PGA/TMC) on patient symptoms and outcomes. A retrospective review of patient perioperative characteristics and postoperative outcomes was conducted for cases of laparoscopic hiatal hernia repair (LHHR) using a PGA/TMC mesh performed over 21 months. Gastroesophageal reflux disease symptom questionnaire responses were compared between preoperative and three postoperative time points. Ninety-six patients underwent LHHR with a PGA/TMC mesh. Postoperatively, the number of overall symptoms reported by patients decreased across all postoperative periods (P < 0.001). Patients reported a significant reduction in antacid use long term (P < 0.001). Laryngeal and regurgitation symptoms decreased at all time points (P < 0.05). There was no difference in dysphagia preoperatively and postoperatively at any time point. Individuals undergoing HHR with PGA/TMC mesh experienced improved regurgitation and laryngeal symptoms, and decreased use of antacid medication.


Assuntos
Fundoplicatura/métodos , Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Laparoscopia , Qualidade de Vida , Telas Cirúrgicas , Implantes Absorvíveis , Antiácidos/uso terapêutico , Antiulcerosos/uso terapêutico , Dioxanos , Feminino , Refluxo Gastroesofágico/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Ácido Poliglicólico , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento
3.
Medicine (Baltimore) ; 98(44): e17850, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31689876

RESUMO

BACKGROUND: Lateral humeral condyle fractures are the second most common elbow fracture in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used in the fixation of these fractures. Here, we introduce a new fixation method that uses an absorbable screw. We aim to determine if it is feasible to treat lateral humeral condyle fractures with an absorbable screw by comparing functional outcomes following absorbable screw fixation vs. K-wire fixation. METHODS: Between May 2007 and September 2010, 86 patients were treated with absorbable screws (43 patients) or K-wire (43 patients). All patients had been diagnosed with lateral condyle fractures that were classified as either Jacob type II (unstable) or III. One absorbable screw (3.5 mm-diameter) was used for fixation in 1 group, while two 1.6 to 1.8 mm K-wires were used in the other group. Patients were followed 6 months about the elbow function according to Broberg and Morrey standard. On 5-7 years, the patients were followed about the carrying angle (valgus deformities and varus deformities), range of motion (flexion loss and extension loss), prominent lateral condyle, symptomatic implants, and fishtail deformity. RESULTS: Anatomic reduction was achieved in all patients. Each group had one radial nerve injury that were present preoperatively. Nerve function recovered spontaneously within 3 to 4 weeks of surgery in both patients. No patient developed necrosis of the capitulum in both groups. Nine patients in K-wires group and 2 in absorbable screw group developed symptomatic implants (P = .048). On the sixth month, there was no significant difference on elbow function according to Broberg and Morrey standard. On 5 to 7 years (average, 6.7 ±â€Š1.3 years), valgus deformities was 6.8 ±â€Š1.2 vs 5.7 ±â€Š0.8, varus deformities was 7.2 ±â€Š1.5 vs 5.1 ±â€Š1.9, flexion loss was 12.4 ±â€Š2.2 vs 9.5 ±â€Š3.1, extension loss was 11.1 ±â€Š3.1 vs 10.2 ±â€Š2.7, prominent lateral condyle was 27.9% vs 37.2%, fishtail deformity was 7.3% vs 4.9%, no significant difference between these groups. CONCLUSIONS: Open reduction with absorbable screw fixation is feasible and safe for the treatment of lateral condyle fractures of the humerus in children. LEVEL OF EVIDENCE: Therapeutic III.


Assuntos
Implantes Absorvíveis , Parafusos Ósseos , Fixação Interna de Fraturas/métodos , Fraturas do Úmero/cirurgia , Redução Aberta , Suturas , Adolescente , Fios Ortopédicos , Criança , Feminino , Seguimentos , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/instrumentação , Humanos , Fraturas do Úmero/classificação , Fraturas do Úmero/fisiopatologia , Masculino , Complicações Pós-Operatórias , Amplitude de Movimento Articular , Estudos Retrospectivos
4.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(10): 784-789, 2019 Oct 24.
Artigo em Chinês | MEDLINE | ID: mdl-31648460

RESUMO

Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Humanos , Intervenção Coronária Percutânea , Polímeros , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
5.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(10): 790-797, 2019 Oct 24.
Artigo em Chinês | MEDLINE | ID: mdl-31648461

RESUMO

Objective: To explore the value of SYNTAX revascularization index (SRI) on evaluating the long-term prognosis of coronary artery disease (CAD) patients implanted with biodegradable polymer drug-eluting stents (BP-DES) and define the best threshold of SRI for predicting all-cause mortality in these patients. Methods: Data used in this study derived from the I-LOVE-IT 2 trial (evaluate safety and effectiveness of the Tivoli DES and the Firebird DES for treatment of coronary). I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, non-inferiority study. A total of 1 829 patients implanted with BP-DES were divided into 3 groups, namely SRI=100% group (n=963), 50%≤SRI<100% group (n=527) and SRI<50% group (n=339). The primary endpoint was 48-month patient-oriented composite endpoint (PoCE), a composite of all-cause mortality, myocardial infarction(MI), stroke, and/or any revascularization. The secondary endpoints were components of PoCE and definite/probable stent thrombosis at 48 months. The receiver operating characteristic curve was used to investigate the best cut-off point of SRI for 48-month all-cause mortality. The Cox regression analysis was used to identify independent predictors of the all-cause death and PoCE at 48 months. Results: Incidence of PoCE at 48 months was significantly lower in SRI=100% group than patients with 50%≤SRI<100%(17.34% (167/963) vs. 22.20% (117/527), P<0.05) and SRI<50% (17.34% (167/963) vs. 24.78% (84/339), P<0.05). Comparing with SRI=100% group, the patients with 50%≤SRI<100% suffered higher rates of all MI (7.78% (41/527) vs. 4.26% (41/963), P<0.05) and target vessel MI (6.45% (34/527) vs. 4.26% (41/963), P<0.05); patients with SRI<50% had higher rates of all-cause mortality (5.90% (20/339) vs. 3.12% (30/963), P<0.05) and any revascularization (14.16% (48/339) vs. 3.12% (30/963), P<0.05). The receiver operating characteristic curve analysis showed that the SRI=65% was the best cut-off point to predict the all-cause mortality at 48 months (area under the curve was 0.58, sensitive was 0.47, specificity was 0.70). Meanwhile, SRI<65% was an independent predictor of 48-month all-cause mortality (HR=2.06, 95%CI 1.25-3.38) and PoCE (HR=1.34, 95%CI 1.09-1.66). Conclusions: SRI serves as a good index for predicting long-term prognosis and SRI<65% is an independent predictor of 48-month PoCE and all-cause mortality for CAD patients with BP-DES implantation. Meanwhile, SRI≥65% might be a reasonable threshold of incomplete revascularization.


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Implantes Absorvíveis , Humanos , Mortalidade , Polímeros , Prognóstico , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento
6.
Beijing Da Xue Xue Bao Yi Xue Ban ; 51(5): 887-892, 2019 Oct 18.
Artigo em Chinês | MEDLINE | ID: mdl-31624394

RESUMO

OBJECTIVE: To evaluate the barrier effect of an absorbable barrier membrane made by small intestinal submucosa (SIS) compared with Bio-Gide collagen membrane. METHODS: 12 healthy New Zealand male white rabbits were randomly assigned. A or B round bone defects with a depth of 2 mm and a diameter of 5 mm or 8 mm was made in each rabbit's mandibular. The following treatments were given respectively: covered with SIS membrane (S), covered with Bio-Gide membrane (G) and blank control (O). Then we got six groups: AS, AG, AO, BS, BG, and BO (n=4). After 4 weeks, the rabbits were sacrificed. The specimens were examined by naked-eye observation, new bone percentage (BV/TV) and bone mineralized density (BMD), which were measured and analyzed by Micro-CT. The data were analyzed with one-way ANOVA. RESULTS: After 4 weeks, Bio-Gide membranes were fused with the surrounding tissue while SIS membranes held the form with no significant degradation. In the AS, BS and AG groups, the absorbable membranes smoothly covered on the new bone. While in the BG group, Bio-Gide membranes collapsed to the center of the bone defects. The 3D reconstruction of Micro-CT showed that a large number of newly formed trabeculae were found in the four groups of AS, BS, AG, and BG. In the central subsidence area of the BG group, the newly formed trabeculae were sparse. However only a small amount of new bone trabecula appeared at the bottom of the defects in groups AO and BO. Micro-CT quantitative results showed that BV/TV (39.10%±0.79%) and BMD [(517.73±11.22) mg/cm3] of AS group were significantly higher than those of AO group [26.67%±1.12%, (319.81±8.00) mg/cm3] (P<0.05), and there was no significant difference between AS group and AG group [38.15%±0.91%, (518.65±7.48) mg/cm3] (P>0.05). BV/TV (34.90%±1.35%) and BMD [(409.09±8.14) mg/cm3] of BS group were significantly higher than those of BO group [23.63%±2.07%, (171.00±16.24) mg/cm3] (P < 0.05). Meanwhile, there was no significant difference between BS and BG groups [33.40%±1.06%, (412.70±8.6) mg/cm3] (P>0.05). HE staining analysis revealed that significant bone formation was achieved in the AS, AG, BS and BG groups, and trabecular bone of AS and AG groups were thicker and denser. In AO and BO group, there were scattered new bone tissues in edges of host bone, and no coarse trabecular bone formed. CONCLUSION: In the early healing of two sizes bone defects in rabbit mandibular, SIS membrane and Bio-Gide membrane have a similar barrier effect in guided bone regeneration. And SIS membrane's ability to maintain space for bone regeneration seems to be better.


Assuntos
Regeneração Óssea , Mandíbula , Implantes Absorvíveis , Animais , Masculino , Osteogênese , Coelhos , Distribuição Aleatória , Suínos , Cicatrização , Microtomografia por Raio-X
7.
Mater Sci Eng C Mater Biol Appl ; 104: 109896, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31499977

RESUMO

Zinc alloys have been explored as potential materials for biodegradable vascular stents due to their tolerable corrosion rates and tunable mechanical properties. However, the performances of Zn alloys were not supported with enough toxicity or biological compatibility evaluation, particularly hemocompatibility for vascular scaffolding application. In this work, the hemocompatibility of three zinc alloys (Zn-0.8Cu, Zn-0.8Mn and Zn-0.8Li) was evaluated with 316 L stainless steel and pure zinc as controls. The hemolysis ratios of 316 L stainless steel, pure Zn, Zn-0.8Cu, Zn-0.8Mn and Zn-0.8Li were 0.38 ±â€¯0.08%, 1.04 ±â€¯0.21%, 0.47 ±â€¯0.21%, 0.57 ±â€¯0.14% and 0.52 ±â€¯0.22%, respectively, for direct contact method. Platelets aggregation on the 316 L stainless steel was observed, while the adhered platelets on the Zn alloys exhibited round shape with few pseudopodia spreading. The number of adhered platelets on the three zinc alloys (Zn-0.8Cu, Zn-0.8Mn and Zn-0.8Li) had no statistically difference compared with 316 L stainless steel, while significant fewer than the pure Zn group. None remarkable platelet activation, hematocyte aggregation, coagulation or complement activation was observed in any Zn alloy group. Furthermore, the Zn alloys prolonged prothrombin time and partial thromboplastin time, demonstrating a potential function of anticoagulation. The results demonstrated that Zn alloys presented in this work are indeed meeting the hemocompatible requirements of implant and showing the promise for perspective application as biodegradable stent.


Assuntos
Ligas/química , Materiais Biocompatíveis/química , Lítio/química , Magnésio/química , Zinco/química , Implantes Absorvíveis , Ligas/administração & dosagem , Materiais Biocompatíveis/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Ativação do Complemento/efeitos dos fármacos , Corrosão , Hemólise/efeitos dos fármacos , Humanos , Lítio/administração & dosagem , Teste de Materiais/métodos , Ativação Plaquetária/efeitos dos fármacos , Aço Inoxidável/química , Stents , Zinco/administração & dosagem
9.
Lancet ; 394(10205): 1243-1253, 2019 10 05.
Artigo em Inglês | MEDLINE | ID: mdl-31488372

RESUMO

BACKGROUND: Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with biodegradable polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stents versus thin strut durable polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. METHODS: The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bülach, Switzerland) consisted of an ultrathin strut cobalt-chromium metallic stent platform releasing sirolimus from a biodegradable polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt-chromium stent platform that releases everolimus from a durable polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov, number NCT02579031. FINDINGS: Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with biodegradable polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with biodegradable polymer sirolimus-eluting stents and 626 (96%) patients treated with durable polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with biodegradable polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable polymer everolimus-eluting stents (difference -1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37-0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. INTERPRETATION: In patients with acute STEMI undergoing primary PCI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents. FUNDING: Biotronik.


Assuntos
Implantes Absorvíveis , Prótese Vascular , Stents Farmacológicos , Everolimo/uso terapêutico , Imunossupressores/uso terapêutico , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Sirolimo/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polímeros , Método Simples-Cego
10.
J Craniomaxillofac Surg ; 47(10): 1498-1503, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31402207

RESUMO

PURPOSE: The purpose of this study was to compare the stability of the chin between absorbable plate and screws with a template device and titanium plate after advancement genioplasty in class II patients. PATIENTS AND METHODS: The subjects consisted of 22 Japanese class II patients who underwent genioplasty advancement in combination with bi-maxillary surgery. After genioplasty horizontal osteotomy, the template plate and screws were fixed at the central region of the chin temporarily. Then, two absorbable bi-cortical screws (uncalcined and unsintered hydroxyapatite and poly-l-lactic acid: uHA/PLLA) were used and fixed bilaterally. After removal of the template plate and screws, one absorbable plate and screws were added to fix the segment in the advancement genioplasty (n = 14). The remaining 8 patients underwent genioplasty advancement surgery with the conventional titanium plate. For all patients, lateral cephalograms were obtained pre- and immediately after surgery and at 1 year after surgery. Change in the Pogonion (Pog) and Menton (Me) points and the corresponding soft tissue points (PogS and MeS) were evaluated. RESULTS: Although there were no significant differences in the change from before to immediately after surgery between the absorbable and titanium groups, there were significant differences in the Pog (Y) (P = 0.0379) and PogS (Y) (P = 0.0379) from immediately after surgery to after 1 year between both groups. CONCLUSION: This study shows that predicted advancement of the chin in the absorbable group could be achieved by using a template and screws, and likewise in the titanium group. However, this study suggested that vertical relapse to the inferior site or resorption at the antero-superior edge of the segment could occur in the absorbable group.


Assuntos
Mentoplastia , Implantes Absorvíveis , Parafusos Ósseos , Cefalometria , Queixo , Humanos , Má Oclusão de Angle Classe II/cirurgia , Mandíbula
11.
J Mater Sci Mater Med ; 30(8): 94, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31414232

RESUMO

Clinically, S53P4 bioactive glass (BAG) has shown very promising results in bone infection treatment, but it is also known to degrade very slowly in vivo. To evaluate which mechanisms (cellular or dissolution) can play a role in the degradation of S53P4 BAG and S53P4 BAG putty, in vitro degradation experiments at different pH (7.4 and 4.6) were performed. Micro computed tomography showed a rapid dissolution of the synthetic binder in the putty formulation, within 12 h is simulated body fluid (pH = 7.4), leaving behind only loose granules. Therefore the degradation of the loose granules was investigated further. Significant weight loss was observed and ion chromatography showed that Ca2+, Na+ and PO43- ions were released from S54P4 BAG granules in the two fluids. It was observed that the weight loss and ion release were increased when the pH of the fluid was decreased to 4.6. Osteoclasts are known to create such a low pH when resorbing bone and therefore their capacity to degrade S53P4 surfaces were studied as well. Scanning electron microscopy and energy-dispersive X-ray spectroscopy confirmed that osteoclasts were able to create resorption pits in the calcium phosphate layer on S53P4 BAG surfaces. The silica of the BAG, located underneath the calcium phosphate, seemed to hinder further osteclastic resorption of the material. To our knowledge we were the first to observe actively resorbing osteoclasts on S53P4 bioactive glass surfaces, in vitro. Future research is needed to define the specific role osteoclasts play in the degradation of BAG in vivo.


Assuntos
Implantes Absorvíveis , Substitutos Ósseos/farmacocinética , Fosfatos de Cálcio/farmacocinética , Vidro , Osteoclastos/fisiologia , Adsorção , Substitutos Ósseos/química , Fosfatos de Cálcio/química , Diferenciação Celular , Células Cultivadas , Vidro/química , Humanos , Teste de Materiais , Monócitos/fisiologia
12.
Plast Reconstr Surg ; 144(3): 685-692, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31461027

RESUMO

BACKGROUND: The purpose of this study was to investigate surgical outcomes with the use of resorbable plating systems for the repair of craniomaxillofacial trauma in the pediatric population. METHODS: A systematic review of the literature was performed. A descriptive analysis, operative technical data, outcomes, and postoperative complications with the use of absorbable plating systems for craniomaxillofacial trauma were included. RESULTS: The systematic literature review identified 1264 abstracts, of which only 19 met inclusion criteria. From these 19 studies, 312 clinical cases with 443 facial fractures that were treated with absorbable fixation systems were extracted for analysis. The review identified only level III/IV (n = 17) and level V (n = 2) studies. Minor and major complications were rare, occurring in 5.45 percent (n = 17) and 3.21 percent (n = 10) of cases, respectively. The most common complications were surgical-site infections (n = 4) and plate extrusion (n = 4). CONCLUSIONS: This report is, to the authors' knowledge, one of the first comprehensive reports on the use of absorbable plating systems for pediatric craniomaxillofacial trauma. Their analysis suggests that the use of absorbable fixation devices for pediatric craniomaxillofacial trauma is relatively safe, with a low-risk profile. Outcome studies with longer follow-up periods specifically investigating facial growth, reoperation rates, standardized surgical outcome metrics, and cost are necessary to effectively compare these fixation devices to titanium alternatives for craniomaxillofacial trauma.


Assuntos
Implantes Absorvíveis , Placas Ósseas , Fixação Interna de Fraturas/instrumentação , Pediatria/métodos , Fraturas Cranianas/cirurgia , Criança , Humanos
14.
Sheng Wu Yi Xue Gong Cheng Xue Za Zhi ; 36(4): 604-612, 2019 Aug 25.
Artigo em Chinês | MEDLINE | ID: mdl-31441261

RESUMO

In vitro experimental test for mechanical properties of a vascular stent is a main method to evaluate its effectiveness and safety, which is of great significance to the clinical applications. In this study, a comparative study of planar, V-groove and radial compression methods for the radial support property test were performed, and the effects of compression rate and circumferential position on the test results were conducted. Based on the three-point bending method, the influences of compression rate and circumferential position on flexibility were also explored. And then a best test proposal was selected to evaluate the radial support property and flexibility of the three self-designed stents and the comparative biodegradable vascular stent (BVS) (BVS1.1, Abbott Vascular, USA) with different outside diameters of 1.4 mm, 1.7 mm and 2.4 mm. The results show that the developing trends of the compression load with the compression displacement measured by the three radial support property test methods are the same, but normalized radial force values are quite different. The planar compression method is more suitable for comparing the radial support properties of stents with different diameters and structures. Compression rate has no obvious effect on the testing results of both the radial support property and flexibility. Compression circumferential position has a great impact on testing radial support property with the planar or V-groove compression methods and testing flexibility with three-point bending method. The radial support properties of all the three self-designed stents are improved at a certain degree compared to that of the BVS stent. The study has better guide significance and reference value for testing mechanical properties of vascular stents.


Assuntos
Implantes Absorvíveis , Fenômenos Mecânicos , Stents , Polímeros , Desenho de Prótese , Estresse Mecânico
15.
World Neurosurg ; 131: 186-190, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31421294

RESUMO

BACKGROUND: Rathke cleft cysts (RCCs) are benign cysts arising from the pars intermedia as a result of incomplete obliteration of the Rathke pouch during development of the pituitary gland. The most common presenting symptoms are headaches, visual disturbances, and endocrinopathies. Recurrence of RCCs after surgical treatment is a well-known phenomenon after surgery with reported recurrence rates as high as 30%. Various methods have been employed to reduce the rate of recurrence. Complete cyst wall resection has been associated with increased rates of perioperative cerebrospinal fluid leak, diabetes insipidus, and carotid injury, while inconsistently demonstrating reduced recurrence rates. Marsupialization, in which the cyst cavity is widely exposed and left open with or without a fat graft suspension, has similarly shown increased morbidity without clear improvement in outcomes. We report here the use of a steroid-eluting sinus stent to maintain patency of the cyst opening. CASE DESCRIPTION: A 39-year-old female presented with a symptomatic RCC. She underwent 4 different surgeries including cyst wall resection, marsupialization, and fat graft placement. She developed short-term symptomatic and radiographic recurrence within 3 months of each surgery. She then underwent placement of a steroid-eluting sinus stent. At 3 months, the patient remained symptom free, without radiographic recurrence and with patent cyst fenestration on nasal endoscopy. CONCLUSIONS: Recurrent RCCs are challenging to manage. Strategies to reduce recurrence are typically associated with higher risk and varying success. Stent placement represents a simple, low-risk method of potentially maintaining patency of cyst fenestration.


Assuntos
Implantes Absorvíveis , Cistos do Sistema Nervoso Central/terapia , Implantes de Medicamento , Cirurgia Endoscópica por Orifício Natural , Stents , Adulto , Feminino , Humanos , Neuroendoscopia , Hipófise , Recidiva , Esteroides/administração & dosagem
16.
Bratisl Lek Listy ; 120(8): 545-551, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31379174

RESUMO

INTRODUCTION: BVS proved safe in humans. ABSORB trials showed them performing similar to Drug Eluting Stents in simple coronary interventions. We assessed a registry of 63 patients with bifurcation lesions, treated by BVS and followed their outcomes up-to 5 years. METHODS: Patients who satisfied the inclusion criteria were included. Data about contact information, baseline characteristics, findings of coronary angiogram, details of their interventional treatment; short and long-term outcomes up till 5 years was collected. RESULTS: Acute feasibility of implantation in bifurcation was high (98 %). Rate of stent thrombosis, acute or sub-acute, was 3.1 %. Rate of re-intervention was 38 %. The average time for an event to occur was 1.6±0.8 years. Over 5 years, 56 % had developed MACE. Patients with MACE were more likely females, hypertensive, smokers, with acute presentations (p=NS), and diabetic (72 % vs 33 % non-diabetic; p=0.002). Patients treated with hybrid strategy of BVS and DES were more likely to develop MACE (64 % vs 49 % for others; P=ns). Patients treated by simple provisional stenting were less likely to develop MACE (45 % vs 60.5 %; p=ns). The average SYNTAX score of MACE patients was 27 vs 20; p=0.06). Diabetes was independently associated with MACE. Hypertension was of borderline statistical significance (2-sided Log rank for Hypertension p=0.06, for Diabetes p=0.01). DISCUSSION: The use of multiple stenting strategies to treat true bifurcation lesions using BVS is feasible with low rate of serious adverse events, albeit on the long run, the rate of re-intervention is high and stringent follow up is required (Tab. 7, Fig. 3, Ref. 37).


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Tecidos Suporte , Angiografia Coronária , Stents Farmacológicos , Humanos , Resultado do Tratamento
17.
J Craniomaxillofac Surg ; 47(11): 1752-1757, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31445877

RESUMO

PURPOSE: The recent development of bioresorbable bone plates and screws allows plates to be applied to the load-bearing regions of the mandible and to remain in place over time without the need for removal. We hypothesized that the stability of composite plates and screws forged from unsintered hydroxyapatite particles and poly-l-lactide (u-HA/PLLA) is comparable to that of standard titanium fixation systems for the reduction of fractures of load-bearing regions of the mandibular body. MATERIALS AND METHODS: 40 patients underwent open reduction and internal fixation of the fractured mandibular body with either a titanium or u-HA/PLLA bone plate. Cone-beam CT images were obtained immediately postoperatively and at 6-month follow-up, and were analyzed for positional changes of the affected mandible. RESULTS: There were no significant differences in the postoperative positional changes of reference points between the titanium and u-HA/PLLA miniplates, except for that for the coronoid process (p-value = 0.03). Multivariate regression analysis revealed no significant differences in spatial changes between the immediate postoperative and 6-month follow-up images, after adjusting for age and sex. CONCLUSION: The stability of bioresorbable u-HA/PLLA miniplates and screws was comparable to that of titanium miniplates and screws immediately postoperatively and at 6-month follow-up, following surgical reduction of fractures of load-bearing regions of the mandibular body. Bioresorbable osteosynthesis can be considered a viable alternative to titanium osteosynthesis.


Assuntos
Implantes Absorvíveis , Placas Ósseas , Fraturas Mandibulares/cirurgia , Procedimentos Cirúrgicos Ortognáticos/instrumentação , Poliésteres/química , Titânio/química , Tomografia Computadorizada de Feixe Cônico , Durapatita , Fixação Interna de Fraturas , Humanos , Mandíbula/diagnóstico por imagem , Resultado do Tratamento
18.
Int J Mol Sci ; 20(15)2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31374825

RESUMO

Because Mg-Ca-Zn alloys are biodegradable and obviate secondary implant removal, they are especially beneficial for pediatric patients. We examined the degradation performance of Mg-Ca-Zn alloys depending on the surface modification and investigated the in vivo effects on the growth plate in a skeletally immature rabbit model. Either plasma electrolyte oxidation (PEO)-coated (n = 18) or non-coated (n = 18) Mg-Ca-Zn alloy was inserted at the distal femoral physis. We measured the degradation performance and femoral segment lengths using micro-CT. In addition, we analyzed the histomorphometric and histopathologic characteristics of the growth plate. Although there were no acute, chronic inflammatory reactions in either group, they differed significantly in the tissue reactions to their degradation performance and physeal responses. Compared to non-coated alloys, PEO-coated alloys degraded significantly slowly with diminished hydrogen gas formation. Depending on the degradation rate, large bone bridge formation and premature physeal arrest occurred primarily in the non-coated group, whereas only a small-sized bone bridge formed in the PEO-coated group. This difference ultimately led to significant shortening of the femoral segment in the non-coated group. This study suggests that optimal degradation could be achieved with PEO-coated Mg-Ca-Zn alloys, making them promising and safe biodegradable materials with no growth plate damage.


Assuntos
Implantes Absorvíveis , Ligas/química , Cálcio/química , Lâmina de Crescimento/fisiologia , Magnésio/química , Zinco/química , Animais , Pinos Ortopédicos , Materiais Revestidos Biocompatíveis/química , Eletrólitos/química , Lâmina de Crescimento/ultraestrutura , Teste de Materiais , Oxirredução , Coelhos , Propriedades de Superfície
19.
BMC Musculoskelet Disord ; 20(1): 357, 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31387574

RESUMO

BACKGROUND: Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures. METHODS: The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson's score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life. DISCUSSION: This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation. TRIAL REGISTRATION: DRKS, DRKS00013368 . Registered Dec 04, 2017.


Assuntos
Implantes Absorvíveis/efeitos adversos , Parafusos Ósseos/efeitos adversos , Fixação Interna de Fraturas/instrumentação , Osso Escafoide/lesões , Traumatismos do Punho/cirurgia , Adolescente , Adulto , Ensaios Clínicos Fase IV como Assunto , Estudos de Equivalência como Asunto , Fixação Interna de Fraturas/efeitos adversos , Humanos , Magnésio/efeitos adversos , Imagem por Ressonância Magnética , Masculino , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação/estatística & dados numéricos , Osso Escafoide/diagnóstico por imagem , Osso Escafoide/cirurgia , Titânio/efeitos adversos , Resultado do Tratamento , Traumatismos do Punho/diagnóstico por imagem , Traumatismos do Punho/fisiopatologia , Articulação do Punho/diagnóstico por imagem , Articulação do Punho/fisiopatologia , Adulto Jovem
20.
World Neurosurg ; 131: e503-e507, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31382070

RESUMO

BACKGROUND: The purpose of the present study was to compare the surgical site infection (SSI) rates between resorbable plates and titanium plates used for adult patients with intractable epilepsy who had undergone epilepsy surgery after subdural electrode placement. METHODS: We performed subdural electrode surgery, followed by epilepsy surgery, for 87 adult patients with intractable epilepsy. The epilepsy surgery included 75 focus resections and 12 corpus callosotomies. We compared the SSI rates between patients who had undergone cranioplasty with titanium and resorbable plates after epilepsy surgery. RESULTS: Of the 87 patients, 43 had undergone cranioplasty with resorbable plates (group A) and 44 had undergone cranioplasty with titanium plates (group B). The frequency of SSI was significantly greater in group A (7 patients; 16.3%) than in group B (1 patient; 2.3%; P = 0.03, Fisher's exact test). Univariate regression analysis also showed a significantly greater infection rate with the resorbable plates (P = 0.024). CONCLUSION: For epilepsy surgery of adult patients after subdural electrode placement surgery, the SSI rate for cranioplasty was greater with resorbable plates than with titanium plates.


Assuntos
Implantes Absorvíveis , Placas Ósseas , Epilepsia Resistente a Medicamentos/cirurgia , Procedimentos Cirúrgicos Reconstrutivos/métodos , Crânio/cirurgia , Infecção da Ferida Cirúrgica/epidemiologia , Titânio , Adulto , Estudos de Casos e Controles , Eletrodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Reconstrutivos/instrumentação , Espaço Subdural , Adulto Jovem
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