BOVINE LYOPHILIZED GRAFT (BLG): HISTOLOGICAL ANALYSIS ON BEHAVIOR IN HUMANS AFTER 49 MONTHS.

OBJECTIVE: To analyze the histological behavior of bovine lyophilized grafts (BLG) produced according to a protocol developed by the first author, in humans over a 49-month period by measuring the graft/bone neoformation ratio in relation to the total mineralized area. METHODS: This was a case series involving 12 patients: eight females (66%) and four males (34%), totaling 13 biopsies. BLG was used, and surgical reintervention was subsequently required during the period 2000 to 2011. The slides produced were stained with hematoxylin-eosin (HE), were analyzed by a pathologist and were digitized for the proposed evaluation. RESULTS: The mean age was 57 years and the mean follow-up was 49 months (range: 6-115). The average proportion of BLG was 42% (range: 13-85) and neoformed bone, 58% (range: 15-87) in relation to the total area mineralized. CONCLUSIONS: This study demonstrated that the BLG used presented osteoconductive characteristics and biocompatibility. BLG is a therapeutic option that can be used in orthopedic surgery in which bone defects need to be filled.

Enxerto bovino liofilizado: comportamento histológico após seguimento de 49 meses em seres humanos / Bovine lyophilized graft (BLG): histological analysis on behavior in humans after 49 months

OBJETIVO: Analisar o comportamento histológico do ELB, produzido conforme protocolo desenvolvido pelo autor principal, em seres humanos no decorrer de 49 meses através da aferição da proporção enxerto/osso neoformado em relação ao total de área mineralizada. MÉTODOS: Série de casos com 12 pacientes, oito femininos (66%) e quatro masculinos (34%), totalizando 13 biópsias, nos quais utilizou-se ELB e que posteriormente houve necessidade de reintervenção cirúrgica, no período de 2000 a 2011. As lâminas produzidas, coradas com hematoxilina-eosina (HE), foram analisadas por patologista e digitalizadas para a avaliação proposta. RESULTADOS: A média etária foi de 57 anos e o tempo médio de seguimento de 49 meses (6-115). A proporção média de ELB foi de 42% (13-85) e de osso neoformado de 58% (15-87) em relação ao total de área mineralizada. CONCLUSÕES: O presente estudo demonstra que o ELB utilizado apresenta característica osteocondutora e biocompatibilidade. O ELB apresentado é opção terapêutica a ser utilizada em cirurgias ortopédicas que necessitem preenchimento de deficiências ósseas.

OBJECTIVE: To analyze the histological behavior of bovine lyophilized grafts (BLG) produced according to a protocol developed by the first author, in humans over a 49-month period by measuring the graft/bone neoformation ratio in relation to the total mineralized area. METHODS: This was a case series involving 12 patients: eight females (66%) and four males (34%), totaling 13 biopsies. BLG was used, and surgical reintervention was subsequently required during the period 2000 to 2011. The slides produced were stained with hematoxylin-eosin (HE), were analyzed by a pathologist and were digitized for the proposed evaluation. RESULTS: The mean age was 57 years and the mean follow-up was 49 months (range: 6-115). The average proportion of BLG was 42% range: 13-85) and neoformed bone, 58% (range: 15-87) in relation to the total area mineralized. CONCLUSIONS: This study demonstrated that the BLG used presented osteoconductive characteristics and biocompatibility. BLG is a therapeutic option that can be used in orthopedic surgery in which bone defects need to be filled.

Caracterização físico-química do enxerto de osso bovino liofilizado / Physicochemical characterization of lyophilized bovine bone grafts

OBJETIVO: Avaliar as características físico-químicas do enxerto bovino liofilizado manufaturado em escala semi-industrial (OrthoGen, Baumer S/A*) de acordo com protocolo previamente desenvolvido pelos autores. MÉTODOS: A caracterização do enxerto de osso bovino liofilizado foi feita por meio de microscopia eletrônica de varredura (MEV), energy dispersive spectroscopy (EDS), difratometria de raios-X, análise por termogravimetria, análise de calorimetria exploratória diferencial (DSC) e espectroscopia por infravermelho Fourier-transform (FT-IR). RESULTADOS: Ca foi o principal componente (60 por cento) encontrado nas amostras, seguido por P (28 por cento) e O (5 por cento). O tamanho médio (dp) dos poros foi 316µm (146,7), variando de 91,2 a 497,8µm, e 333,5µm (304,8), variando de 87,2 a 963,9µm com 50x e 150x magnificação, respectivamente. Picos de hidroxiapatita foram a 26ºC e 32ºC, e perda de massa foi observada entre 250ºC e 640ºC, correspondendo material orgânico e água. Duas transições de temperatura (45,67°C e 91,89°C) mostraram desnaturação de colágeno tipo I e desidratação da hidroxiapatita. CONCLUSÃO: A avaliação físico-química do enxerto de osso bovino liofilizado, de acordo com o protocolo desenvolvido em escala semi-industrial, confirma que este produto apresenta excelente biocompatibilidade, com características semelhantes ao osso in natura.

OBJECTIVE: To evaluate the physicochemical characteristics of lyophilized bovine grafts manufactured on a semi-industrial scale (Orthogen; Baumer S/A*) in accordance with a protocol previously developed by the authors. METHODS: The lyophilized bovine bone grafts were characterized by means of scanning electron microscopy (SEM), energy dispersive spectroscopy (EDS), X-ray diffractometry (XRD), thermogravimetric (TG) analysis, differential exploratory scanning calorimetry (DSC) and Fourier-transform infrared (FT-IR) spectroscopy. RESULTS: Ca was the main component (60 percent) found in the samples, followed by P (28 percent) and O (5 percent). The mean (sd) pore size was 316 µm (146.7), ranging from 91.2 to 497.8 µm, and 333.5 µm (304.8), ranging from 87.2 to 963.9 µm, at 50x and 150x magnification, respectively. The hydroxyapatite peaks were at 26°C and 32°C, and mass losses were observed between 250°C and 640°C, corresponding to organic material and water. Two temperature transitions (45.67°C and 91.89°C) showed denaturation of type 1 collagen and dehydration of hydroxyapatite. CONCLUSION: The physicochemical assessment of lyophilized bovine bone grafts in accordance with the protocol developed at semi-industrial scale confirmed that this product presents excellent biocompatibility, with characteristics similar to natural bone.

Caracterização de uma haste femoral de Ti-6Al-4V não cimentada / Characterization of a cementless Ti-6Al-4V femoral stem

O objetivo deste estudo foi determinar a viabilidade de produção de uma prótese femoral de titânio garantindo a qualidade da matéria prima e as características das superfícies. Um protótipo foi criado pelo Método de Elementos Finitos em AutoCad® 2000. A simulação dos esforços demonstrou uma tensão de von Mises 8,1 vezes menor que a tensão crítica para escoamento do material. Na determinação dos constituintes metálicos, obteve-se: Fe  =   0,06%, Al  = 6,20%, V  = 3,57%, O  = 0,115%, N  = 0,003%, H  = 0,010%, e ausência de metais pesados. As propriedades elasto-plásticas da amostra tiveram valor médio de dureza de 4,45 (3,92 a 4,79) GPa e o módulo de elasticidade variou de 112,12 a 140,77  GPa (média  = 134,33). O coeficiente de rugosidade médio (DP) no cone foi de 0,60  (0,03) μm; na região jateada de 12,2 (0,8) μm e na ponta de 0,41 (0,01) μm. Nos ensaios de fadiga e de corrosão não foram observadas alterações. A análisegranulométrica do pó do material depositado demonstrou predominância de partículas médias (75  μm a 180  μm; 84%). A espessura da camada do material depositado apresentou valor médio de 52,7  μm (0 a 318  μm), porosidade média de 16% (variandode 3% a 41%), poros de diâmetro médio de 88,5  μm e profundidade média de 28,2  μm. A tensão (força por unidade de área) de adesão da camada porosa depositada revelou valoresde 15 a 17  MPa. Em conclusão, os resultados dos testes e ensaios técnicos estão dentro das normas internacionalmente recomendadas e padronizadas para implantes metálicos em titânio estando essa prótese de acordo com os padrões internacionaisde qualidade e segurança.

The objective of this work was to study the feasibility of manufacturing a cementless femoral prosthesis in Brazil, in compliance with internationalstandards of quality assurance. A virtual prototype by the Finite Elements Model in AutoCad® 2000 was assessed and demonstrated a von Mises tension 8.1 below the deformation point. In determining the metallic components, the percentages were Fe  = 0.06%, Al  = 6.20%, V  = 3.57%, O  = 0.115%, N  = 0.003%, H  = 0.010% without any contamination due to heavy metals. The elasto-plastic properties showed an average value of hardness of 4.45 (3.92 to 4.79) GPa and elasticity module varied from 112.12 to 140.77  GPa (mean  = 134.33). The average coefficient of roughness (SD) in the cone was 0.60 (0.03) μm, 12.2 (0.8) μm in the plasma spray coating region, and 0.41 (0.01) μm in the tip. In the assays for fatigue and corrosion no changes were observed. The grain size analysis of the deposited material dust demonstrated predominantly (84%) medium size particles (75  μm to 180  μm). The thickness of the deposited material layer presented average value of 52.7  μm (0 to 318  μm), average porosity of 16% (varying from 3% to 41%) and pores of average diameterof 88.5  μm and average depth of 28.2  μm. The force of adhesion of the deposited porous layer showed values between 15  and  17  MPa. Results were in accordance with the norms and tests internationally recommended and standardized for metallic implants in titanium alloy and  the femoral prosthesis manufactured with national technology was in accordance with international standards of design, quality and safeness.

Acetabular reconstruction with human and bovine freeze-dried bone grafts and a reinforcement device.

BACKGROUND: This is a cohort trial (1997-2005) of 49 patients submitted to an acetabular component revision of a total hip arthroplasty, using impacted human and bovine freeze-dried cancellous bone grafts (H&FDBG) and a reinforcement device. OBJECTIVE: To compare clinical/radiographic graft incorporation capability between cancellous bone grafts. PATIENTS/METHODS: There were two groups: I (n=26) receiving human grafts and II (n=25) receiving bovine grafts. The average follow-up times were 55 and 49 months, respectively. Clinical analysis was based on the Merle d'Aubigné and Postel score, and the radiographic analysis involved an established score based on Conn's et al. criteria for radiographic bone incorporation. RESULTS: No clinical/radiographic differences were found between the groups and both showed an overall rate of 88.5% and 76% of graft incorporation (p=0.424). CONCLUSION: The results presented here are comparable to those in the literature with the use of deep-FG. Therefore, cancellous bone grafts can be safely and adequately used in acetabular component revision in total hip arthroplasty.

Acetabular reconstruction with human and bovine freeze-dried bone grafts and a reinforcement device

BACKGROUND: This is a cohort trial (1997-2005) of 49 patients submitted to an acetabular component revision of a total hip arthroplasty, using impacted human and bovine freeze-dried cancellous bone grafts (H&FDBG) and a reinforcement device. OBJECTIVE: To compare clinical/radiographic graft incorporation capability between cancellous bone grafts. PATIENTS/METHODS: There were two groups: I (n=26) receiving human grafts and II (n=25) receiving bovine grafts. The average follow-up times were 55 and 49 months, respectively. Clinical analysis was based on the Merle d'Aubigné and Postel score, and the radiographic analysis involved an established score based on Conn's et al. criteria for radiographic bone incorporation. RESULTS: No clinical/radiographic differences were found between the groups and both showed an overall rate of 88.5 percent and 76 percent of graft incorporation (p=0.424). CONCLUSION: The results presented here are comparable to those in the literature with the use of deep-FG. Therefore, cancellous bone grafts can be safely and adequately used in acetabular component revision in total hip arthroplasty.