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.
|Number of pages||11|
|Journal||Journal of the Mechanical Behavior of Biomedical Materials|
|Publication status||Published - 2021|
- Additive manufacturing
- Patient-specific implants
- Surgical guides
- Temporomandibular joint