In Vitro and In Vivo Evaluation of Lyophilized Bovine Bone Biocompatibility

INTRODUCTION: The use of bone grafts in orthopedic, maxillofacial and dental surgery has been growing. Nevertheless, both fresh autografts and frozen allografts have limitations, and therefore, alternative synthetic or natural biomaterials, such as processed and lyophilized bovine bone graft have been developed. OBJECTIVE: To evaluate in vitro and in vivo biocompatibility of lyophilized bovine bone manufactured in a semi-industrial scale, according to a modifical protocol developed by the authors. METHODS: Samples of bovine cancellous bone were processed according to a protocol developed by Kakiuchi et al., and modified to process samples of bovine cancellous bone. The following trials were performed: in vitro cytotoxicity, in vivo acute systemic toxicity, in vivo oral irritation potential, in vitro pyrogenic reaction, and bioburden. RESULTS: The in vitro evaluation of lyophilized bovine cancellous bone revealed an absence of cytotoxicity in 100% of the samples. Regarding in vivo evaluation of acute systemic toxicity, neither macroscopic abnormalities nor deaths were noted in the animals. Pyrogenicity was not greater than 0.125 UE/ml in any of the samples. The bioburden revealed negative results for microbial growth before sterilization. Regarding the oral irritation potential, in vivo evaluation at 24 and 72 hours showed that the animals had no edema or erythema on the oral mucosa. CONCLUSION: The protocol changes established by the authors to prepare lyophilized bovine cancellous bone at a semi-industrial scale is reproducible and yielded a product with excellent biocompatibility

Mid-term follow-up of acetabular reconstruction using bovine freeze-dried bone graft and reinforcement device

Relatar a capacidade clínica e radiográfica de integração de enxertos ósseos liofilizados bovinos. Método: Vinte e cinco pacientes foram incluídos. O período médio de acompanhamento foi de oito anos. Os enxertos foram purificados e liofilizados. A análise clínica baseou-se no escore de Merle d’Aubigné e Postel, e critérios de pontuação estabelecidos para a osteointegração radiográfica foram usados para as análises radiográficas. Resultados: Bons resultados clínicos e radiográficos foram observados em 80% e 72% dos casos, respectivamente. Conclusão: Enxertos liofilizados bovinos podem ser usados com segurança e adequadamente na revisão acetabular da artroplastia total de quadril.Objective: To report clinical and radiographic graft incorporation capability of bovine freeze-dried bone grafts. Methods: Twenty five patients were enrolled. The mean follow-up was eight years. Grafts were purified and freeze-dried. Clinical analysis was based on the score of Merle d’Aubigné and Postel and an established score criteria for radiographic bone incorporation was used for radiographic analyses. Results: Good clinical and radiographic results were found in 80% and 72% of the cases, respectively. Conclusion: Bovine freeze-dried grafts can be safely and adequately used in acetabular revision in total hip arthroplasty

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%) encontrado nas amostras, seguido por P (28%) e O (5%). 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%) found in the samples, followed by P (28%) and O (5%). 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

Acompanhamento a médio prazo da reconstrução acetabular com enxerto ósseo liofilizado bovino e dispositivo de reforço

OBJETIVO: Relatar a capacidade clínica e radiográfica de integração de enxertos ósseos liofilizados bovinos. MÉTODO: Vinte e cinco pacientes foram incluídos. O período médio de acompanhamento foi de oito anos. Os enxertos foram purificados e liofilizados. A análise clínica baseou-se no escore de Merle d'Aubigné e Postel, e critérios de pontuação estabelecidos para a osteointegração radiográfica foram usados para as análises radiográficas. RESULTADOS: Bons resultados clínicos e radiográficos foram observados em 80% e 72% dos casos, respectivamente. CONCLUSÃO: Enxertos liofilizados bovinos podem ser usados com segurança e adequadamente na revisão acetabular da artroplastia total de quadril

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% 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