期刊
JOURNAL OF THE MECHANICAL BEHAVIOR OF BIOMEDICAL MATERIALS
卷 119, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.jmbbm.2021.104512
关键词
Additive manufacturing; Temporomandibular joint; Surgical guides; Patient-specific implants
资金
- Interreg 2Seas programme - European Regional Development Fund [2S04014]
This study reviewed clinical studies on the use of AM patient-specific surgical guides and implants, finding that existing data often lack comprehensive evaluation of clinical outcomes.
Additive manufacturing (AM) offers great design freedom that enables objects with desired unique and complex geometry and topology to be readily and cost-effectively fabricated. The overall benefits of AM are well known, such as increased material and resource efficiency, enhanced design and production flexibility, the ability to create porous structures and on-demand manufacturing. When AM is applied to medical devices, these benefits are naturally assumed. However, hard clinical evidence collected from clinical trials and studies seems to be lacking and, as a result, systematic assessment is yet difficult. In the present work, we have reviewed 23 studies on the clinical use of AM patient-specific surgical guides (PSGs) for the mandible surgeries (n = 17) and temporomandibular joint (TMJ) patient-specific implants (PSIs) (n = 6) with respect to expected clinical outcomes. It is concluded that the data published on these AM medical devices are often lacking in comprehensive evaluation of clinical outcomes. A complete set of clinical data, including those on time management, costs, clinical outcomes, range of motion, accuracy of the placement with respect to the pre-operative planning, and extra complications, as well as manufacturing data are needed to demonstrate the real benefits gained from applying AM to these medical devices and to satisfy regulatory requirements.
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