Customized acrylic implants for reconstruction of extensive skull defects: an exception approach for selected patients

Denadai, Rafael; Raposo‐Amaral, Cesar Augusto; Guidi, Marcelo; Raposo-Amaral, Cássio Eduardo; Buzzo, Celso Luiz

doi:10.1590/0100-69912017002008

Cited by 6 publications

(4 citation statements)

References 32 publications

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“…Recent study on custom‐designed bone implants has mainly focuses on dentures or teeth, maxillary or mandible, and femurs. Other notable implant types include those for the humerus, the cranium/skull, and the tibia …”

Section: Features Of Customized Bone Implant Devicesmentioning

confidence: 99%

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Correlation Between Conditional Approval and Customized Bone Implant Devices

Guo¹,

Liu²,

Lu³

2019

Orthopaedic Surgery

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This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them. Based on the experience of approval of the first domestic custom‐designed bone implant, we consider the process of gaining conditional approval for urgently‐needed medical devices and medical devices for rare diseases, as well as the guidance available for clinical investigation. We also streamlined the scientifically administrative concept of this unique device, from the design and development of premarket technical evaluation to continuous post‐market study. The present study found that those two aspects have certain connections, but they are not directly correlated to each other. In contrast to the USA, Canada, Australia and the EU, where regulations and guidelines have been established for the use of customized devices, in this regard, China is still it its infancy. Thus, there is considerable potential for China to develop and perfect the policies relating to customized devices and to develop relevant strategies to ensure their efficacy with the aid of conditional approval. Appropriate scientific conditional approval for mass production of individualized anatomy‐matching bone implants could become a valuable approach for precision medicine.

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Section: Features Of Customized Bone Implant Devicesmentioning

confidence: 99%

“…Other notable implant types include those for the humerus, the cranium/skull, and the tibia. [11][12][13][14] . Among all the implants introduced, it should be noted that some are applied as a substitute for bone or scaffold, while others act as additions to support or fix an original bone in the correct position.…”

Section: Classificationmentioning

confidence: 99%

Correlation Between Conditional Approval and Customized Bone Implant Devices

Guo¹,

Liu²,

Lu³

2019

Orthopaedic Surgery

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“…In addition to reducing surgical time, digital software allows mirroring of contralateral structures or personalized reconstructions in a virtual environment. The object created for reconstruction can be made (printed or milled) in the grafting material or a negative impression can be used as a template for using the PMMA (Da Silva et al, 2017;Đurić et al, 2019). Inclusion of technologies for planning and making facial skull reconstructions, as observed in the present case, is a reality and should, in the authors' view, be encouraged to optimize clinical results.…”

Section: Discussionmentioning

confidence: 88%

“…The results obtained in the present case emphasize the importance of these techniques for achieving a satisfactory aesthetic resolution. When applicable, autogenous bone grafts are considered the gold standard for cranial reconstructions, however the bioavailability of this type of graft can be an obstacle for major reconstructions, as reported in this case (Da Silva et al, 2017).…”

Section: Discussionmentioning

confidence: 95%

The importance of reestablishing orbitary architecture for rehabilitation with an ocular prosthesis: a case report

Dallazen

Queiroz

Llantada

et al. 2021

RSD

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Anophthalmia is mainly caused by two etiological groups, trauma and medical conditions. In addition, anophthalmia creates difficulties in social, professional, and family adaptation due to psychological, and functional disorders related to eye loss. Studies show a positive influence on the personal relationship of patients with anophthalmia after being rehabilitated with ocular prostheses. However, in order to achieve a good aesthetic result in prosthetic eye rehabilitation, it is essential that the size and positioning of the orbital skeleton are adequate. Facial trauma can also cause defects associated with bone loss, and in these cases, reconstructive techniques aim to restore the appropriate bone contour. The aim of this work is to report a case where reconstructive treatment was performed on a patient victim of a long-term traffic accident sequel, using an alloplastic implant in polymethylmethacrylate (PMMA) and bone repositioning, so that an ocular prosthesis could be made. At the end of the treatment, after reconstruction of the frontal-nasal region in PMMA and repositioning of the left zygoma, the aesthetic objectives were achieved and the patient improved his self-esteem and social life.

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Anatomical Fat Grafting for Reconstruction of Frontotemporal Contour Deformities After Neurosurgical and Craniofacial Surgical Interventions: A Symmetry Outcome Study

et al. 2019

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Customized acrylic implants for reconstruction of extensive skull defects: an exception approach for selected patients

Abstract: as cranioplastias dos pacientes com defeitos da calota craniana extensos devem ser criteriosamente indicadas, obedecendo a critérios pré-determinados de seleção dos pacientes, bem como, do método de customização do implante de acrílico.

Cited by 6 publications

References 32 publications

Correlation Between Conditional Approval and Customized Bone Implant Devices

Correlation Between Conditional Approval and Customized Bone Implant Devices

The importance of reestablishing orbitary architecture for rehabilitation with an ocular prosthesis: a case report

Anatomical Fat Grafting for Reconstruction of Frontotemporal Contour Deformities After Neurosurgical and Craniofacial Surgical Interventions: A Symmetry Outcome Study

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