Dataset Information

Cochlear implant positioning and fixation using 3D-printed patient specific surgical guides; a cadaveric study.

ABSTRACT:

Hypothesis

To develop and validate the optimal design and evaluate accuracy of individualized 3D- printed surgical guides for cochlear implantation.

Background

Positioning and fixation of the cochlear implant (CI) are commonly performed free hand. Applications of 3-dimensional (3D) technology now allow us to make patient specific, bone supported surgical guides, to aid CI surgeons with precise placement and drilling out the bony well which accommodates the receiver/stimulator device of the CI.

Methods

Cone beam CT (CBCT) scans were acquired from temporal bones in 9 cadaveric heads (18 ears), followed by virtual planning of the CI position. Surgical, bone-supported drilling guides were designed to conduct a minimally invasive procedure and were 3D-printed. Fixation screws were used to keep the guide in place in predetermined bone areas. Specimens were implanted with 3 different CI models. After implantation, CBCT scans of the implanted specimens were performed. Accuracy of CI placement was assessed by comparing the 3D models of the planned and implanted CI's by calculating the translational and rotational deviations.

Results

Median translational deviations of placement in the X- and Y-axis were within the predetermined clinically relevant deviation range (< 3 mm per axis); median translational deviation in the Z-axis was 3.41 mm. Median rotational deviations of placement for X-, Y- and Z-rotation were 5.50°, 4.58° and 3.71°, respectively.

Conclusion

This study resulted in the first 3D-printed, patient- and CI- model specific surgical guide for positioning during cochlear implantation. The next step for the development and evaluation of this surgical guide will be to evaluate the method in clinical practice.

SUBMITTER: Markodimitraki LM

PROVIDER: S-EPMC9312396 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:3D printed surgical guides are used for prosthetically-driven oral implant placement. When manufacturing these guides, information regarding suitable printing techniques and materials as well as the necessity for additional, non-printed stock parts such as metal sleeves is scarce. The aim of the investigation was to determine the accuracy of a surgical workflow for oral implant placement using guides manufactured by means of fused deposition modeling (FDM) from a biodegradable and sterilizable biopolymer filament. Furthermore, the potential benefit of metal sleeve inserts should be assessed. A surgical guide was designed for the installation of two implants in the region of the second premolar (SP) and second molar (SM) in a mandibular typodont model. For two additive manufacturing techniques (stereolithography [SLA]: reference group, FDM: observational group) n = 10 surgical guides, with (S) and without (NS) metal sleeves, were used. This resulted in 4 groups of 10 samples each (SLA-S/NS, FDM-S/NS). Target and real implant positions were superimposed and compared using a dedicated software. Sagittal, transversal, and vertical discrepancies at the level of the implant shoulder, apex and regarding the main axis were determined. MANOVA with posthoc Tukey tests were performed for statistical analyses. Placed implants showed sagittal and transversal discrepancies of <1 mm, vertical discrepancies of <0.6 mm, and axial deviations of ?3°. In the vertical dimension, no differences between the four groups were measured (p ? 0.054). In the sagittal dimension, SLA groups showed decreased deviations in the implant shoulder region compared to FDM (p ? 0.033), whereas no differences in the transversal dimension between the groups were measured (p ? 0.054). The use of metal sleeves did not affect axial, vertical, and sagittal accuracy, but resulted in increased transversal deviations (p = 0.001). Regarding accuracy, biopolymer-based surgical guides manufactured by means of FDM present similar accuracy than SLA. Cytotoxicity tests are necessary to confirm their biocompatibility in the oral environment.