Bone Allograft Safety and Performance

Moucha, Calin S.; Renard, Régis; Gandhi, Ankur; Tuan, Rocky S.

doi:10.1007/978-1-84628-366-6_3

Cited by 6 publications

(9 citation statements)

References 57 publications

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“…9,10 The strength of structural allograft bone is affected by several factors including bone mineral density (BMD), donor age and sex, graft dimension, and sterilization and storage techniques. 2,3,[15][16][17][18][19][20][21] Despite this, no standard screening protocol utilized by allograft bone providers exists for factors such as donor age and sex, BMD, or structural graft dimensions. 1 One reason for this absence of consistent practices within the allograft industry may be a lack of objective data on which to base screening thresholds with respect to parameters related to structural allograft strength.…”

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confidence: 99%

Relationship of donor variables and graft dimension on biomechanical performance of femoral ring allograft

Hart

Daniels

Bahney

et al. 2011

Journal Orthopaedic Research

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Structural femoral ring allograft is commonly used in interbody spinal arthrodesis. Fractures of implanted femoral ring allograft have been reported. Data to guide donor screening and tissue processing by allograft tissue banks for factors that affect graft strength are incomplete. Fresh frozen human femora from 34 cadaveric donors were sectioned into ten 20-mm thick specimens. Bone mineral density (BMD), donor age, and graft dimensions were recorded for each specimen. Three hundred twenty-seven specimens were tested in quasi-static axial compression. Linear regression models compared load to failure with BMD, sex-specific donor age, minimum/maximum cortical wall thickness, and minimum/maximum outer ring diameter. Correlations between minimum and maximum cortical wall thickness and load to failure were significant (r ¼ 0.73, p < 0.001 and r ¼ 0.74, p < 0.001, respectively). BMD showed a weaker negative correlation with load to failure (r ¼ À0.11, p ¼ 0.05). Correlations between load to failure and minimum and maximum outer ring diameter and age (r ¼ 0.06, p ¼ 0.31) were not significant. We found that the minimum and maximum cortical wall thicknesses of femoral ring allograft are strongly correlated with the axial compressive load to failure of the graft. Other tested parameters did not prove to be effective predictors of resistance to axial loading. ß

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confidence: 99%

Relationship of donor variables and graft dimension on biomechanical performance of femoral ring allograft

Hart

Daniels

Bahney

et al. 2011

Journal Orthopaedic Research

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“…The same authors reported a Young's modulus of 445 ± 237 MPa for fresh-frozen CBG which is in the range of our findings with 311.4 ± 34.7 MPa for the untreated specimen. Treated CBGs, often applied as morselized allograft are used to fill bone cavities while cortical bone grafts are applied for the reconstruction of smaller cortical bone defects and for structural support [ 6 , 7 ]. From this point of view proper biomechanical performance of a cortical bone graft may be of higher clinical relevance compared to that of a CBG whereas the preservation of osteoinductive properties/biocompatibility and favorable remodeling rate are more relevant for CBGs.…”

Section: Discussionmentioning

confidence: 99%

“…When seeding with human mesenchymal stromal cells no negative effect in biocompatibility was found after PE treatment as already shown in our previous work [ 27 ]. In contrast to the chemical treatment with PE it has been reported that residual ethylene oxide in allografts caused moderate inflammation from residual ethylene oxide and impaired the new bone [ 7 , 62 ]. Therefore the disinfection with PE can be more recommended for bone graft sterilization when used as a filling material.…”

Section: Discussionmentioning

confidence: 99%

“…However, autologous bone grafting is associated with postoperative donor site morbidity, for example, neurovascular injury, persisting pain, hematoma, and fracture as well as limited availability and reduced quality in old patients and patients with bone metabolism compromising comorbidities, for example, osteoporosis [ 4 , 5 ]. In this context, the application of bone allografts possessing both osteoconductive and at best partially osteoinductive properties, usually provided by local bone or tissue banks, denotes an appealing alternative [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

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Comparative Biomechanical and Microstructural Analysis of Native versus Peracetic Acid-Ethanol Treated Cancellous Bone Graft

Rauh

Despang

Baas

et al. 2014

BioMed Research International

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Bone transplantation is frequently used for the treatment of large osseous defects. The availability of autologous bone grafts as the current biological gold standard is limited and there is a risk of donor site morbidity. Allogenic bone grafts are an appealing alternative, but disinfection should be considered to reduce transmission of infection disorders. Peracetic acid-ethanol (PE) treatment has been proven reliable and effective for disinfection of human bone allografts. The purpose of this study was to evaluate the effects of PE treatment on the biomechanical properties and microstructure of cancellous bone grafts (CBG). Forty-eight human CBG cylinders were either treated by PE or frozen at −20°C and subjected to compression testing and histological and scanning electron microscopy (SEM) analysis. The levels of compressive strength, stiffness (Young's modulus), and fracture energy were significantly decreased upon PE treatment by 54%, 59%, and 36%, respectively. Furthermore, PE-treated CBG demonstrated a 42% increase in ultimate strain. SEM revealed a modified microstructure of CBG with an exposed collagen fiber network after PE treatment. We conclude that the observed reduced compressive strength and reduced stiffness may be beneficial during tissue remodeling thereby explaining the excellent clinical performance of PE-treated CBG.

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“…The allograft bone industry is guided by practices intended to optimize safety and effectiveness of allograft bone in numerous clinical applications. Guidelines have been developed and used with respect to avoidance of transmission of neoplastic and infectious disease based on high level scientific data . Adherence to these guidelines has resulted in safe and successful allograft implantation over many years of experience .…”

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confidence: 99%

Bone mineral density and donor age are not predictive of femoral ring allograft bone mechanical strength

2014

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While metal or plastic interbody spinal fusion devices are manufactured to appropriate mechanical standards, mechanical properties of commercially prepared structural allograft bone remain relatively unassessed. Robust models predicting compressive load to failure of structural allograft bone based on easily measured variables would be useful. Three hundred twenty seven femoral rings from 34 cadaver femora were tested to failure in axial compression. Predictive variables included age, gender, bone mineral density (BMD), position along femoral shaft, maximum/minimum wall thickness, outer/inner diameter, and area. We used support vector regression and 10-fold cross-validation to develop robust nonlinear predictive models for load to failure. Model performance was measured by the root-mean-squared-deviation (RMSD) and correlation coefficients (r). A polynomial model using all variables had RMSD ¼ 7.92, r ¼ 0.84, indicating excellent performance. A model using all variables except BMD was essentially unchanged (RMSD ¼ 8.12, r ¼ 0.83). Eliminating both age and BMD produced a model with RMSD ¼ 8.41, r ¼ 0.82, again essentially unchanged. Compressive strength of structural allograft bone can be estimated using easily measured geometric parameters, without including BMD or age. As DEXA is costly and cumbersome, and setting upper age-limits for potential donors reduces the supply, our results may prove helpful to increase the quality and availability of structural allograft. Keywords: structural bone allograft; spinal fusion; biomechanics; bone mineral densityThe allograft bone industry is guided by practices intended to optimize safety and effectiveness of allograft bone in numerous clinical applications. Guidelines have been developed and used with respect to avoidance of transmission of neoplastic and infectious disease based on high level scientific data. 1,2 Adherence to these guidelines has resulted in safe and successful allograft implantation over many years of experience. 3 Despite this excellent track record, the mechanical properties of what is essentially a mechanical device 4 remain comparatively un-assessed. In fact, there are no guidelines prescribed with respect to material properties of structural allograft bone products within the Food and Drug Administration or the American Association of Tissue Banks. 2,5 A recent survey of allograft providers demonstrated that given this lack of guidelines, a variety of practices are employed with regard to screening of donors and allografts. 6 On the other hand, interbody spacers manufactured using materials such as carbon fiber, titanium, or polyetheretherketone are expected to have consistent biomechanical properties. 7-9 While the cited advantages of allograft bone over such implants include lower cost and equal or better clinical performance, 10-21 the mechanical performance of structural allograft bone intended for use as an interbody device should be similarly uniform and reliable.We have accumulated a database of load to failure measurements for fem...

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Bone Allograft Safety and Performance

Cited by 6 publications

References 57 publications

Relationship of donor variables and graft dimension on biomechanical performance of femoral ring allograft

Relationship of donor variables and graft dimension on biomechanical performance of femoral ring allograft

Comparative Biomechanical and Microstructural Analysis of Native versus Peracetic Acid-Ethanol Treated Cancellous Bone Graft

Bone mineral density and donor age are not predictive of femoral ring allograft bone mechanical strength

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