https://doi.org/10.1016/j.bioactmat.2022.04.014

Evidence-based biomaterials research

• This article elucidates the relationship between biomaterials & regulatory science. • Regulatory authorities approve/clear final medical products, not biomaterials. • No definition/regulation on the so-called medical-grade or implantable materials. • Regulatory science helps to assess safety and efficacy of medical products. • Safety and efficacy refer to final medical products, not biomaterials alone. The fast development of both biomaterials and regulatory science calls for a convergence, which is addressed in this article via their link through medical products of biomaterials and related safety and efficacy evaluation. The updated definition of biomaterials, and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly introduced. Then a brief overview of the concept and history of regulatory science and its assessment of safety and efficacy of medical products, as well as the currently ongoing biomaterials-related regulatory science programs are presented. Finally, the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed. As the first article in the field to elucidate the relationship between biomaterials and regulatory science, key take-home messages include (1) biomaterials alone are not medical products; (2) regulatory authorities approve/clear final medical products, not biomaterials; (3) there is no definition/regulation on the so-called medical-grade or implantable materials; and (4) safety and efficacy refer to final medical products, not biomaterials alone. 

Biomaterials and regulatory science

https://doi.org/10.1016/j.bioactmat.2022.02.005

Translation of biomaterials from bench to clinic

The clinical effects of two different methods–high-viscosity cement percutaneous vertebroplasty (PVP) and low-viscosity cement percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fractures (OVCFs) were investigated. From June 2010 to August 2013, 98 cases of OVCFs were included in our study. Forty-six patients underwent high-viscosity PVP and 52 patients underwent low-viscosity PKP. The occurrence of cement leakage was observed. Pain relief and functional activity were evaluated using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI), respectively. Restoration of the vertebral body height and angle of kyphosis were assessed by comparing preoperative and postoperative measurements of the anterior heights, middle heights and the kyphotic angle of the fractured vertebra. Nine out of the 54 vertebra bodies and 11 out of the 60 vertebra bodies were observed to have cement leakage in the high-viscosity PVP and low-viscosity PKP groups, respectively. The rate of cement leakage, correction of anterior vertebral height and kyphotic angles showed no significant differences between the two groups (P>0.05). Low-viscosity PKP had significant advantage in terms of the restoration of middle vertebral height as compared with the high-viscosity PVP (P<0.05). Both groups showed significant improvements in pain relief and functional capacity status after surgery (P<0.05). It was concluded that high-viscosity PVP and low-viscosity PKP have similar clinical effects in terms of the rate of cement leakage, restoration of the anterior vertebral body height, changes of kyphotic angles, functional activity, and pain relief. Low-viscosity PKP is better than high-viscosity PVP in restoring the height of the middle vertebra.

A Comparative Study of High-viscosity Cement Percutaneous Vertebroplasty vs. Low-viscosity Cement Percutaneous Kyphoplasty for Treatment of Osteoporotic Vertebral Compression Fractures

The long-term stability of total hip replacements (THRs) critically depends on the lasting integrity of the bond between the implant and the bone. Late failure in the absence of infection is known as ‘aseptic loosening’, a process characterised by the formation and progressive thickening of a continuous layer of fibrous tissue at the interface between the prosthesis and the bone. Aseptic loosening has been identified as the most common cause for long-term instability leading to the failure of ace-tabular cups. There is clearly a need to study the failure mechanisms in the acetabular fixation if the long-term stability of THR is to be significantly improved. The bonding strength in the presence of defects is measured using interfacial fracture toughness, and this information is not available currently. In this work, interfacial fracture toughness of synthetic and bovine bone-cement interface has been studied using sandwiched Brazilian disk specimens. Experiments were carried out using a common bone cement, CMW, and polyurethane foam under selected loading angles from 0 to 25 degrees to achieve full loading conditions from tensile (mode I) to shear (mode II). Finite element analyses were carried out to obtain the solutions for strain energy release rate at a given phase angle (ratio of shear and tensile stress) associated with the experimental models. The effects of crack length on the measured interfacial fracture toughness were examined. Microscopic studies were also carried out to obtain the morphology of the fractured interfaces at selected loading angles. The results show that both polyurethane foam and bovine cancellous bone seem to produce a similar type of interfacial failure of bone-cement interface, with cement pedicles being ‘pull-out’ of the pores of the foam/ bone. Damage sustained by the cement pedicles seems to increase progressively as the increase of shear loading component. The measured values of fracture toughness are a function of crack length and phase angle, and are comparable with those published in the literature on cortical bone and cement interface. The implication of these results on the assessment of fixation in acetabular replacements is discussed, particularly in the light of results from bovine cancellous bone-cement interface.

P51 determination of interfacial fracture toughness of bone-cement interface using sandwich brazilian disks

Translation of a spinal bone cement product from bench to bedside

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Translation of a spinal bone cement product from bench to bedside