A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation

Abstract Background During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We aim to compare the migration rates of two fixation techniques, the bony recess versus the subperiosteal tight pocket without bony sutures. Methods and analysis This single-blind randomized controlled trial will recruit a total of 112 primary cochlear implantation adult patients, eligible for implantation according to the current standard of practice. Randomization will be performed by an electronic data capture system Castor EDC, with participants block randomized to either bony recess or standard subperiosteal tight pocket in a 1:1 ratio, stratified by age. The primary outcome of this study is the R/S device migration rate; secondary outcomes include patient-experienced burden using the validated COMPASS questionnaire, electrode migration rate, electrode impedance values, speech perception scores, correlation between R/S migration, electrode array migration and patient complaints, assessment of complication rates, and validation of an implant position measurement method. Data will be collected at baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 12 months after surgery. All data analyses will be conducted according to the intention-to-treat principle. Discussion Cochlear implantation by means of creating a tight subperiosteal pocket without drilling a bony seat is a minimally invasive fixation technique with many advantages. However, the safety of this technique has not yet been proven with certainty. This is the first randomized controlled trial that directly compares the minimally invasive technique with the conventional method of drilling a bony seat. Trial registration Netherlands Trial Register NL9698. Registered on 31 August 2021

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

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 (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

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

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

Reliability and Agreement of 3D Anthropometric Measurements in Facial Palsy Patients Using a Low-Cost 4D Imaging System

The reliability (precision) and agreement (accuracy) of anthropometric measurements based on manually placed 3D landmarks using the RealSense D415 were investigated in this paper. Thirty facial palsy patients, with their face in neutral (resting) position, were recorded simultaneously with the RealSense and a professional 3dMD imaging system. First the RealSense depth accuracy was determined. Subsequently, two observers placed 14 facial landmarks on the 3dMD and RealSense image, assessing the distance between landmark placement. The respective intra- and inter-rater Euclidean distance between the landmark placements was 0.84 mm (±0.58) and 1.00 mm (±0.70) for the 3dMD landmarks and 1.32 mm (±1.27) and 1.62 mm (±1.42) for the RealSense landmarks. From these landmarks 14 anthropometric measurements were derived. The intra- and inter-rater measurements had an overall reliability of 0.95 (0.87 - 0.98) and 0.93 (0.85 - 0.97) for the 3dMD measurements, and 0.83 (0.70 - 0.91) and 0.80 (0.64 - 0.89) for the RealSense measurements, respectively, expressed as the intra-class correlation coefficient. Determined by the Bland-Altman analysis, the agreement between the RealSense measurements and 3dMD measurements was on average -0.90 mm (-4.04 - 2.24) and -0.89 mm (-4.65 - 2.86) for intra- and inter-rater agreement, respectively. Based on the reported reliability and agreement of the RealSense measurements, the RealSense D415 can be considered as a viable option to perform objective 3D anthropomorphic measurements on the face in a neutral position, where a low-cost and portable camera is required

Depth accuracy of the RealSense F200 : Low-cost 4D facial imaging

The RealSense F200 represents a new generation of economically viable 4-dimensional imaging (4D) systems for home use. However, its 3D geometric (depth) accuracy has not been clinically tested. Therefore, this study determined the depth accuracy of the RealSense, in a cohort of patients with a unilateral facial palsy (n = 34), by using the clinically validated 3dMD system as a gold standard. The patients were simultaneously recorded with both systems, capturing six Sunnybrook poses. This study has shown that the RealSense depth accuracy was not affected by a facial palsy (1.48 ± 0.28 mm), compared to a healthy face (1.46 ± 0.26 mm). Furthermore, the Sunnybrook poses did not influence the RealSense depth accuracy (p = 0.76). However, the distance of the patients to the RealSense was shown to affect the accuracy of the system, where the highest depth accuracy of 1.07 mm was measured at a distance of 35 cm. Overall, this study has shown that the RealSense can provide reliable and accurate depth data when recording a range of facial movements. Therefore, when the portability, low-costs, and availability of the RealSense are taken into consideration, the camera is a viable option for 4D close range imaging in telehealth